Back to resultsTesting the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Primary Purpose
Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Fallopian Tube Undifferentiated Carcinoma
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Biospecimen Collection
Carboplatin
Cediranib Maleate
Computed Tomography
Echocardiography
Gemcitabine
Gemcitabine Hydrochloride
Laboratory Biomarker Analysis
Magnetic Resonance Imaging
Multigated Acquisition Scan
Olaparib
Paclitaxel
Pegylated Liposomal Doxorubicin Hydrochloride
Pharmacological Study
Quality-of-Life Assessment
Sponsored by
About this trial
This is an interventional treatment trial for Fallopian Tube Clear Cell Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
Patients must have platinum-sensitive recurrent high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancers; patients with other (clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma) high-risk histologies are also eligible, provided that the patient has a known deleterious germline BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory; Note: Due to the long acceptance of germline BRCA testing through Myriad, Myriad testing will be accepted; if testing for germline BRCA is done by other organizations, documentation from a qualified medical professional (e.g., ovarian cancer specialty physician involved in the field, high risk genetics physician, genetics counselor) listing the mutation and confirming that the laboratory results showed a recognized germline deleterious BRCA1 or BRCA2 mutation or BRCA rearrangement is required; please collect a copy of Myriad or other BRCA mutational analysis (positive or VUS or negative) reports
- Platinum-sensitive disease defined as no clinical or radiographic evidence of disease recurrence for > 6 months (or 182 days) after last receipt of platinum-based therapy
- Patients must have had a complete clinical response to their prior line of platinum therapy and cannot have had progression through prior platinum-based therapy
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
Patients must have evaluable disease - defined as one of the following:
- Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable disease OR
- Evaluable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related) AND a cancer antigen 125 (CA125) that has doubled from the post-treatment nadir and is also greater than 2 times upper limit of normal (ULN)
Prior therapy:
- Prior chemotherapy must have included a first-line platinum-based regimen with or without intravenous consolidation chemotherapy
- Patients may have received an unlimited number of platinum-based therapies in the recurrent setting
- Patients may have received up to 1 non-platinum-based line of therapy in the recurrent setting; prior hormonal therapy will not be considered to count as this non-platinum-based line
- Patients may not have had a prior anti-angiogenic agent in the recurrent setting; prior use of bevacizumab in the upfront or upfront maintenance setting is allowed
- Patients may not have previously received a poly adenosine diphosphate (ADP) ribose polymerase (PARP)-inhibitor
- Prior hormonal-based therapy for ovarian, primary peritoneal, or fallopian tube cancer is acceptable
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (Karnofsky >= 60%)
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Hemoglobin >= 10 g/dL
- Creatinine =< the institutional upper limit of normal (ULN) OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- Urine protein: creatinine ratio (UPC) of =< 1 or less than or equal to 2+ proteinuria on two consecutive dipsticks taken no less than 1 week apart; UPC is the preferred test; patients with >= 2+ proteinuria on dipstick must also have a 24 hour urine collection demonstrating =< 500 mg over 24 hours
- Total bilirubin =< 1.5 x the institutional ULN
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 times institutional ULN
- Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE); patients with long-standing stable grade 2 neuropathy may be considered after discussion with the overall principal investigator (PI), but may not receive carboplatin and paclitaxel as the reference regimen, if randomized to that arm
- Patients must be able to swallow and retain oral medications and without gastrointestinal illnesses that would preclude absorption of cediranib or olaparib
- Patients must have adequately controlled blood pressure (BP), with a BP no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility; patients must have a BP of =< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of three antihypertensive medications; it is strongly recommended that patients who are on three antihypertensive medications be followed by a cardiologist or blood pressure specialist for management of blood pressure while on protocol
- Patients must be willing and able to check and record daily blood pressure readings; blood pressure cuffs will be provided to patients randomized to Arm III
- Cediranib has been shown to terminate fetal development in the rat, as expected for a process dependent on VEGF signaling; for this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential must agree to use two reliable forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 weeks after cediranib discontinuation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid stimulating hormone (TSH) within normal limits
- Age >= 18
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of starting treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients may not have had hormonal therapy within 2 weeks prior to entering the study; patients receiving raloxifene for bone health as per Food and Drug Administration (FDA) indication may remain on raloxifene absent other drug interactions
- Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks
- Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)
- Patients may not have received prior treatment affecting the vascular endothelial growth factor (VEGF) pathway (including, but not limited to thalidomide, sunitinib, pazopanib, sorafenib, and nintedanib); bevacizumab used in the upfront setting in conjunction with chemotherapy and/or as maintenance to treat newly diagnosed disease will be allowed
- Patients may not have previously received a PARP inhibitor
- CA-125 only disease without RECIST 1.1 measurable or otherwise evaluable disease
- Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on CT or MRI scans should not be included on this study, since neurologic dysfunction may confound the evaluation of neurologic and other adverse events; screening imaging to rule out brain metastases is not required for screening, but should be performed prior to study enrollment if clinically indicated; patients with treated brain metastases and resolution of any associated symptoms must demonstrate stable post-therapeutic imaging for at least 6 months following therapy prior to starting study drug
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib
- Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; strong inhibitors and inducers of UGT/PgP should be used with caution
- History of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula
- History of intra-abdominal abscess within the past 3 months
- Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
- Dependency on intravenous (IV) hydration or total parenteral nutrition (TPN)
Any concomitant or prior invasive malignancies with the following curatively treated exceptions:
- Treated limited stage basal cell or squamous cell carcinoma of the skin
- Carcinoma in situ of the breast or cervix
- Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous/serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
- Prior cancer treated with a curative intent with no evidence of recurrent disease 3 years following diagnosis and judged by the investigator to be at low risk of recurrence
Patients with any of the following:
- History of myocardial infarction within six months
- Unstable angina
- Resting electrocardiogram (ECG) with clinically significant abnormal findings
- New York Heart Association (NYHA) classification of III or IV
If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines
Patients with the following risk factors should have a baseline cardiac function assessment:
- Prior treatment with anthracyclines
- Prior treatment with trastuzumab
- Prior central thoracic radiation therapy (RT), including RT to the heart
- History of myocardial infarction within 6 to 12 months (patients with history of myocardial infarction within 6 months are excluded from the study)
- Prior history of impaired cardiac function
- History of stroke or transient ischemic attack within six months
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- Clinically significant peripheral vascular disease or vascular disease (including aortic aneurysm or aortic dissection)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (other than atrial fibrillation with controlled ventricular rate), or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study because cediranib and olaparib are agents with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with cediranib and olaparib, breastfeeding should be discontinued if the mother is treated with cediranib or olaparib; these potential risks may also apply to other agents used in this study
- Known HIV-positive individuals are ineligible because of the potential for pharmacokinetic interactions with cediranib or olaparib; in addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy
- Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies as they may interfere with the effectiveness of the study treatments
- No features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated
- No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- University of South Alabama Mitchell Cancer Institute
- Alaska Women's Cancer Care
- Providence Alaska Medical Center
- Arizona Oncology Associates-West Orange Grove
- Arizona Oncology Associates-Wilmot
- University of Arkansas for Medical Sciences
- PCR Oncology
- Mercy San Juan Medical Center
- Marin Cancer Care Inc
- UC San Diego Moores Cancer Center
- Cedars Sinai Medical Center
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Kaiser Permanente-Oakland
- Palo Alto Medical Foundation Health Care
- Sutter Roseville Medical Center
- Mercy Cancer Center - Sacramento
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente - Sacramento
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- UCSF Medical Center-Mission Bay
- Pacific Central Coast Health Center-San Luis Obispo
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Sutter Pacific Medical Foundation
- Palo Alto Medical Foundation-Sunnyvale
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- Woodland Memorial Hospital
- Rocky Mountain Cancer Centers-Aurora
- UCHealth University of Colorado Hospital
- Penrose-Saint Francis Healthcare
- UCHealth Memorial Hospital Central
- Kaiser Permanente-Franklin
- Rocky Mountain Cancer Centers-Rose
- Poudre Valley Hospital
- Kaiser Permanente-Rock Creek
- Rocky Mountain Cancer Centers-Littleton
- Kaiser Permanente-Lone Tree
- Rocky Mountain Cancer Centers-Sky Ridge
- SCL Health Lutheran Medical Center
- Smilow Cancer Hospital Care Center-Fairfield
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- Middlesex Hospital
- The Hospital of Central Connecticut
- Yale University
- Smilow Cancer Hospital-Torrington Care Center
- Smilow Cancer Hospital Care Center-Trumbull
- Helen F Graham Cancer Center
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- TidalHealth Nanticoke / Allen Cancer Center
- Sibley Memorial Hospital
- University of Florida Health Science Center - Gainesville
- University Cancer and Blood Center LLC
- Piedmont Hospital
- Northside Hospital
- Dekalb Medical Center
- Medical Center of Central Georgia
- Memorial Health University Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Queen's Medical Center
- Kapiolani Medical Center for Women and Children
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Cancer Institute - Boise
- Saint Luke's Cancer Institute - Fruitland
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Rush - Copley Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- Rush University Medical Center
- UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Illinois CancerCare-Galesburg
- Northwestern Medicine Cancer Center Delnor
- NorthShore University HealthSystem-Glenbrook Hospital
- NorthShore University HealthSystem-Highland Park Hospital
- Sudarshan K Sharma MD Limited-Gynecologic Oncology
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Cancer Care Center of O'Fallon
- Illinois CancerCare-Ottawa Clinic
- Advocate Lutheran General Hospital
- Illinois CancerCare-Pekin
- Illinois CancerCare-Peoria
- Illinois CancerCare-Peru
- Illinois CancerCare-Princeton
- Springfield Clinic
- Memorial Medical Center
- Northwestern Medicine Cancer Center Warrenville
- Ascension Saint Vincent Indianapolis Hospital
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- University of Iowa/Holden Comprehensive Cancer Center
- Mercy Medical Center-West Lakes
- University of Kansas Cancer Center
- Ascension Via Christi - Pittsburg
- Cotton O'Neil Cancer Center / Stormont Vail Health
- Associates In Womens Health
- Ascension Via Christi Hospitals Wichita
- University of Kentucky/Markey Cancer Center
- Norton Hospital Pavilion and Medical Campus
- Norton Suburban Hospital and Medical Campus
- Norton Brownsboro Hospital and Medical Campus
- Mary Bird Perkins Cancer Center
- Woman's Hospital
- Women's Cancer Care-Covington
- Ochsner Medical Center Jefferson
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Maine Medical Center- Scarborough Campus
- Greater Baltimore Medical Center
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- Johns Hopkins University/Sidney Kimmel Cancer Center
- University of Maryland Shore Medical Center at Easton
- Tufts Medical Center
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
- Lahey Hospital and Medical Center
- Saint Joseph Mercy Hospital
- University of Michigan Comprehensive Cancer Center
- Henry Ford Cancer Institute-Downriver
- Henry Ford Macomb Hospital-Clinton Township
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Green Bay Oncology - Escanaba
- Weisberg Cancer Treatment Center
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Spectrum Health at Butterworth Campus
- West Michigan Cancer Center
- Sparrow Hospital
- Green Bay Oncology-Manistique
- Saint Joseph Mercy Oakland
- Ascension Providence Hospitals - Southfield
- Munson Medical Center
- Henry Ford West Bloomfield Hospital
- Sanford Joe Lueken Cancer Center
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview Southdale Hospital
- Mayo Clinic Health Systems-Mankato
- Fairview Clinics and Surgery Center Maple Grove
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- University of Minnesota/Masonic Cancer Center
- Mayo Clinic in Rochester
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Minnesota Oncology Hematology PA-Woodbury
- Saint Dominic-Jackson Memorial Hospital
- University of Mississippi Medical Center
- Saint Francis Medical Center
- Mercy Hospital Joplin
- Barnes-Jewish Hospital
- Washington University School of Medicine
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Billings Clinic Cancer Center
- Benefis Healthcare- Sletten Cancer Institute
- Kalispell Regional Medical Center
- Community Medical Hospital
- CHI Health Saint Francis
- CHI Health Good Samaritan
- Nebraska Methodist Hospital
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Women's Cancer Center of Nevada
- Wentworth-Douglass Hospital
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- Dartmouth Cancer Center - Nashua
- Memorial Sloan Kettering Basking Ridge
- Cooper Hospital University Medical Center
- Englewood Hospital and Medical Center
- MD Anderson Cancer Center at Cooper-Voorhees
- University of New Mexico Cancer Center
- Southwest Gynecologic Oncology Associates Inc
- Memorial Medical Center - Las Cruces
- Montefiore Medical Center-Einstein Campus
- State University of New York Downstate Medical Center
- Roswell Park Cancer Institute
- Memorial Sloan Kettering Commack
- Memorial Sloan Kettering Westchester
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Memorial Sloan Kettering Cancer Center
- University of Rochester
- Memorial Sloan Kettering Nassau
- Dickstein Cancer Treatment Center
- UNC Lineberger Comprehensive Cancer Center
- Duke University Medical Center
- Southeastern Medical Oncology Center-Goldsboro
- Southeastern Medical Oncology Center-Jacksonville
- FirstHealth of the Carolinas-Moore Regional Hospital
- Duke Raleigh Hospital
- Novant Health New Hanover Regional Medical Center
- Wake Forest University Health Sciences
- Sanford Bismarck Medical Center
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- Trinity Cancer Care Center
- Summa Health System - Akron Campus
- Cleveland Clinic Akron General
- UHHS-Chagrin Highlands Medical Center
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- TriHealth Cancer Institute-Westside
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- The Mark H Zangmeister Center
- Grandview Hospital
- Orion Cancer Care
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- ProMedica Flower Hospital
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
- University Hospitals Sharon Health Center
- UHHS-Westlake Medical Center
- Wright-Patterson Medical Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Charles Health System
- Willamette Valley Cancer Center
- Legacy Mount Hood Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Kaiser Permanente Northwest
- Legacy Meridian Park Hospital
- Jefferson Abington Hospital
- Saint Luke's University Hospital-Bethlehem Campus
- Geisinger Medical Center
- Ephrata Cancer Center
- Adams Cancer Center
- Lancaster General Hospital
- University of Pennsylvania/Abramson Cancer Center
- Thomas Jefferson University Hospital
- West Penn Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- Guthrie Medical Group PC-Robert Packer Hospital
- Geisinger Medical Oncology-Selinsgrove
- Reading Hospital
- UPMC Susquehanna
- WellSpan Health-York Hospital
- Women and Infants Hospital
- AnMed Health Cancer Center
- Medical University of South Carolina
- Gibbs Cancer Center-Gaffney
- Saint Francis Hospital
- Prisma Health Cancer Institute - Faris
- Saint Francis Cancer Center
- Gibbs Cancer Center-Pelham
- South Carolina Cancer Specialists PC
- Spartanburg Medical Center
- MGC Hematology Oncology-Union
- Rapid City Regional Hospital
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Wellmont Medical Associates Oncology and Hematology-Johnson City
- Ballad Health Cancer Care - Kingsport
- Wellmont Holston Valley Hospital and Medical Center
- Thompson Cancer Survival Center
- Thompson Cancer Survival Center - West
- Vanderbilt University/Ingram Cancer Center
- Texas Oncology - Central Austin Cancer Center
- Texas Oncology - South Austin Cancer Center
- Texas Oncology Bedford
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Texas Oncology - Fort Worth Cancer Center
- Houston Methodist Hospital
- Methodist Willowbrook Hospital
- Houston Methodist Sugar Land Hospital
- Texas Oncology-The Woodlands
- Intermountain Medical Center
- Saint George Regional Medical Center
- Utah Cancer Specialists-Salt Lake City
- University of Virginia Cancer Center
- Virginia Commonwealth University/Massey Cancer Center
- Kadlec Clinic Hematology and Oncology
- Skagit Regional Health Cancer Care Center
- Skagit Valley Hospital
- Pacific Gynecology Specialists
- FHCC South Lake Union
- Fred Hutchinson Cancer Research Center
- Swedish Medical Center-First Hill
- University of Washington Medical Center - Northwest
- Women's Cancer Center of Seattle
- University of Washington Medical Center - Montlake
- Legacy Salmon Creek Hospital
- Wenatchee Valley Hospital and Clinics
- West Virginia University Charleston Division
- Edwards Comprehensive Cancer Center
- Marshfield Clinic-Chippewa Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Saint Vincent Hospital Cancer Center Green Bay
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Gundersen Lutheran Medical Center
- Marshfield Clinic - Ladysmith Center
- University of Wisconsin Carbone Cancer Center
- Saint Vincent Hospital Cancer Center at Marinette
- Marshfield Medical Center-Marshfield
- Medical College of Wisconsin
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- ProHealth Oconomowoc Memorial Hospital
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Marshfield Medical Center-Rice Lake
- Ascension Saint Michael's Hospital
- Marshfield Medical Center-River Region at Stevens Point
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
- ProHealth Waukesha Memorial Hospital
- UW Cancer Center at ProHealth Care
- Marshfield Clinic-Wausau Center
- Marshfield Medical Center - Weston
- Marshfield Clinic - Wisconsin Rapids Center
- Tom Baker Cancer Centre
- Cross Cancer Institute
- Juravinski Cancer Centre at Hamilton Health Sciences
- London Regional Cancer Program
- Ottawa Hospital and Cancer Center-General Campus
- Algoma District Cancer Program Sault Area Hospital
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
- University Health Network-Princess Margaret Hospital
- CIUSSSEMTL-Hopital Maisonneuve-Rosemont
- CHUM - Hopital Notre-Dame
- CHUM - Centre Hospitalier de l'Universite de Montreal
- Jewish General Hospital
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
- Iwate Medical University Hospital
- Kagoshima City Hospital
- The Cancer Institute Hospital Of JFCR
- Saitama Medical University International Medical Center
- National Cancer Center Hospital
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Arm I (platinum-based chemotherapy)
Arm II (olaparib)
Arm III (olaparib, cediranib maleate)
Arm Description
See detailed description.
Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
Outcomes
Primary Outcome Measures
Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments. Japanese cohort not included in progression free survival analysis, only included in toxicity assessments.
Secondary Outcome Measures
Overall Survival
Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. Japanese cohort not included in overall survival analysis, the cohort was only included in toxicity assessments.
Frequency and Severity of Adverse Effects
Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy, by Preferred term with incidence rate greater than 5%.
Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical
Disease-related physical symptoms were measured by the Disease-Related Symptom-Physical (DRS-P) subscale of the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NCCN/FOSI-18). The DRS-P subscale is composed of 9 items. For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The DRS-P score ranges 0-36 with a larger score suggesting better QOL (Quality of Life) or less symptoms. This analysis did not include the Japanese cohort.
Full Information
NCT ID
NCT02446600
First Posted
May 11, 2015
Last Updated
September 12, 2023
Sponsor
National Cancer Institute (NCI)
Collaborators
AstraZeneca, NRG Oncology
1. Study Identification
Unique Protocol Identification Number
NCT02446600
Brief Title
Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official Title
A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 28, 2016 (Actual)
Primary Completion Date
February 23, 2020 (Actual)
Study Completion Date
August 9, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)
Collaborators
AstraZeneca, NRG Oncology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.
Detailed Description
PRIMARY OBJECTIVE:
I. Assess the efficacy of either single agent olaparib or the combination of cediranib (cediranib maleate) and olaparib, as measured by progression free survival (PFS), as compared to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.
SECONDARY OBJECTIVES:
I. Assess the efficacy of single agent olaparib or the combination of cediranib and olaparib, as measured by response rate and overall survival as compared to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.
II. Assess the efficacy of single agent olaparib or the combination of cediranib and olaparib, as measured by PFS, in women with or without deleterious germline breast cancer (BRCA) mutations (gBRCAmt) in the setting of recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer.
III. Assess the effect on disease-related symptoms (DRS) as measured by the 9-item DRS-P subscale of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) Ovarian Symptom Index-18 (NFOSI-18), of single agent olaparib or cediranib and olaparib, compared to standard platinum-based chemotherapy, in the setting of recurrent platinum sensitive ovarian, primary peritoneal or fallopian tube cancer.
IV. Assess the efficacy of single agent olaparib or the combination of cediranib and olaparib, as measured by PFS, in women with or without homologous repair deficiencies as measured by BROCA in the setting of recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer.
V. To assess changes in the number of circulating endothelial cells (CECs) following three days of treatment with olaparib, combination olaparib/cediranib, or standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer.
VI. To assess whether change in the number of circulating endothelial cells (CECs) following three days of treatment with olaparib, combination olaparib/cediranib, or standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer is prognostic for PFS.
VII. To develop a profile from a panel of angiogenic biomarkers in women with recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer which is associated with PFS, and then validate the predictive value of this biomarker profile.
EXPLORATORY OBJECTIVES:
I. To assess the time from randomization to the first non-study, anti-cancer therapy, surgery or death (TFST) for single-agent olaparib or combination cediranib and olaparib relative to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.
II. To assess the time from randomization to the second non-study, anti-cancer therapy, surgery or death (TSST) for single-agent olaparib or combination cediranib and olaparib relative to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.
III. Assess the effect on secondary measures of quality of life, as assessed by the treatment side effects (TSE) and function/well-being (F/WB) subscales of the NFOSI-18, sensory neuropathy as measured by the FACT/Gynecologic Oncology Group-Neurotoxicity version 4 (GOG-Ntx-4), and health utility as measured by the Euro Quality of Life-5 Dimension (EQ-5D), of single agent olaparib or cediranib and olaparib, compared to standard platinum-based chemotherapy, in the setting of recurrent platinum sensitive ovarian, primary peritoneal or fallopian tube cancer.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients may be treated with one of the three regimens per investigator discretion.
REGIMEN I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30-60 minutes and on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) as well as blood sample collection throughout the trial.
REGIMEN II: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 for at least 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
REGIMEN III: Patients receive pegylated liposomal doxorubicin hydrochloride IV and carboplatin IV over 30-60 minutes and on day 1. Treatment repeats every 28 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
ARM II: Patients receive olaparib orally (PO) twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
ARM III: Patients receive olaparib PO BID and cediranib maleate PO once daily (QD). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Fallopian Tube Undifferentiated Carcinoma, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Tumor, Ovarian Seromucinous Carcinoma, Ovarian Serous Tumor, Ovarian Transitional Cell Carcinoma, Ovarian Undifferentiated Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Ovarian Endometrioid Adenocarcinoma, Recurrent Primary Peritoneal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
579 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (platinum-based chemotherapy)
Arm Type
Active Comparator
Arm Description
See detailed description.
Arm Title
Arm II (olaparib)
Arm Type
Experimental
Arm Description
Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
Arm Title
Arm III (olaparib, cediranib maleate)
Arm Type
Experimental
Arm Description
Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Undergo blood sample collection
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Cediranib Maleate
Other Intervention Name(s)
AZD2171, AZD2171 Maleate, Recentin
Intervention Description
Given PO
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo CT
Intervention Type
Procedure
Intervention Name(s)
Echocardiography
Other Intervention Name(s)
EC
Intervention Description
Undergo ECHO
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
dFdC, dFdCyd, Difluorodeoxycytidine
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Gemcitabine Hydrochloride
Other Intervention Name(s)
dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar, LY-188011, LY188011
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MRI
Intervention Type
Procedure
Intervention Name(s)
Multigated Acquisition Scan
Other Intervention Name(s)
Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning
Intervention Description
Undergo MUGA
Intervention Type
Drug
Intervention Name(s)
Olaparib
Other Intervention Name(s)
AZD 2281, AZD-2281, AZD2281, KU-0059436, Lynparza, Olanib, Olaparix, PARP Inhibitor AZD2281
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Pegylated Liposomal Doxorubicin Hydrochloride
Other Intervention Name(s)
ATI-0918, Caelyx, Dox-SL, Doxil, Doxilen, Doxorubicin HCl Liposomal, Doxorubicin HCl Liposome, Doxorubicin Hydrochloride Liposome, Duomeisu, Evacet, LipoDox, Lipodox 50, Liposomal Adriamycin, Liposomal Doxorubicin Hydrochloride, Liposomal-Encapsulated Doxorubicin, Pegylated Doxorubicin HCl Liposome, Pegylated Liposomal Doxorubicin, S-Liposomal Doxorubicin, Stealth Liposomal Doxorubicin, TLC D-99
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Pharmacological Study
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria
Description
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments. Japanese cohort not included in progression free survival analysis, only included in toxicity assessments.
Time Frame
The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. Japanese cohort not included in overall survival analysis, the cohort was only included in toxicity assessments.
Time Frame
Approximately 30 months
Title
Frequency and Severity of Adverse Effects
Description
Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy, by Preferred term with incidence rate greater than 5%.
Time Frame
During treatment period and up to 100 days after stopping the study treatment, up to 39 months.
Title
Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical
Description
Disease-related physical symptoms were measured by the Disease-Related Symptom-Physical (DRS-P) subscale of the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NCCN/FOSI-18). The DRS-P subscale is composed of 9 items. For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The DRS-P score ranges 0-36 with a larger score suggesting better QOL (Quality of Life) or less symptoms. This analysis did not include the Japanese cohort.
Time Frame
Prior to cycle 1, week 12, week 24, week 36, week 48, week 60, week 72, week 84, week 96 and 108 weeks after starting treatment
Other Pre-specified Outcome Measures:
Title
Time From Randomization to the First Non-study, Anti-cancer Treatment or Death
Time Frame
Up to 5 years
Title
Time From Randomization to the Second Non-study, Anti-cancer Treatment or Death
Time Frame
Up to 5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have platinum-sensitive recurrent high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancers; patients with other (clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma) high-risk histologies are also eligible, provided that the patient has a known deleterious germline BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory; Note: Due to the long acceptance of germline BRCA testing through Myriad, Myriad testing will be accepted; if testing for germline BRCA is done by other organizations, documentation from a qualified medical professional (e.g., ovarian cancer specialty physician involved in the field, high risk genetics physician, genetics counselor) listing the mutation and confirming that the laboratory results showed a recognized germline deleterious BRCA1 or BRCA2 mutation or BRCA rearrangement is required; please collect a copy of Myriad or other BRCA mutational analysis (positive or VUS or negative) reports
Platinum-sensitive disease defined as no clinical or radiographic evidence of disease recurrence for > 6 months (or 182 days) after last receipt of platinum-based therapy
Patients must have had a complete clinical response to their prior line of platinum therapy and cannot have had progression through prior platinum-based therapy
Patients must have signed an approved informed consent and authorization permitting release of personal health information
Patients must have evaluable disease - defined as one of the following:
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable disease OR
Evaluable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related) AND a cancer antigen 125 (CA125) that has doubled from the post-treatment nadir and is also greater than 2 times upper limit of normal (ULN)
Prior therapy:
Prior chemotherapy must have included a first-line platinum-based regimen with or without intravenous consolidation chemotherapy
Patients may have received an unlimited number of platinum-based therapies in the recurrent setting
Patients may have received up to 1 non-platinum-based line of therapy in the recurrent setting; prior hormonal therapy will not be considered to count as this non-platinum-based line
Patients may not have had a prior anti-angiogenic agent in the recurrent setting; prior use of bevacizumab in the upfront or upfront maintenance setting is allowed
Patients may not have previously received a poly adenosine diphosphate (ADP) ribose polymerase (PARP)-inhibitor
Prior hormonal-based therapy for ovarian, primary peritoneal, or fallopian tube cancer is acceptable
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (Karnofsky >= 60%)
Absolute neutrophil count >= 1,500/mcL
Platelets >= 100,000/mcL
Hemoglobin >= 10 g/dL
Creatinine =< the institutional upper limit of normal (ULN) OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Urine protein: creatinine ratio (UPC) of =< 1 or less than or equal to 2+ proteinuria on two consecutive dipsticks taken no less than 1 week apart; UPC is the preferred test; patients with >= 2+ proteinuria on dipstick must also have a 24 hour urine collection demonstrating =< 500 mg over 24 hours
Total bilirubin =< 1.5 x the institutional ULN
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 times institutional ULN
Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE); patients with long-standing stable grade 2 neuropathy may be considered after discussion with the overall principal investigator (PI), but may not receive carboplatin and paclitaxel as the reference regimen, if randomized to that arm
Patients must be able to swallow and retain oral medications and without gastrointestinal illnesses that would preclude absorption of cediranib or olaparib
Patients must have adequately controlled blood pressure (BP), with a BP no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility; patients must have a BP of =< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of three antihypertensive medications; it is strongly recommended that patients who are on three antihypertensive medications be followed by a cardiologist or blood pressure specialist for management of blood pressure while on protocol
Patients must be willing and able to check and record daily blood pressure readings; blood pressure cuffs will be provided to patients randomized to Arm III
Cediranib has been shown to terminate fetal development in the rat, as expected for a process dependent on VEGF signaling; for this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential must agree to use two reliable forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 weeks after cediranib discontinuation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid stimulating hormone (TSH) within normal limits
Age >= 18
Exclusion Criteria:
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of starting treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients may not have had hormonal therapy within 2 weeks prior to entering the study; patients receiving raloxifene for bone health as per Food and Drug Administration (FDA) indication may remain on raloxifene absent other drug interactions
Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks
Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)
Patients may not have received prior treatment affecting the vascular endothelial growth factor (VEGF) pathway (including, but not limited to thalidomide, sunitinib, pazopanib, sorafenib, and nintedanib); bevacizumab used in the upfront setting in conjunction with chemotherapy and/or as maintenance to treat newly diagnosed disease will be allowed
Patients may not have previously received a PARP inhibitor
CA-125 only disease without RECIST 1.1 measurable or otherwise evaluable disease
Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on CT or MRI scans should not be included on this study, since neurologic dysfunction may confound the evaluation of neurologic and other adverse events; screening imaging to rule out brain metastases is not required for screening, but should be performed prior to study enrollment if clinically indicated; patients with treated brain metastases and resolution of any associated symptoms must demonstrate stable post-therapeutic imaging for at least 6 months following therapy prior to starting study drug
History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib
Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; strong inhibitors and inducers of UGT/PgP should be used with caution
History of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula
History of intra-abdominal abscess within the past 3 months
Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
Dependency on intravenous (IV) hydration or total parenteral nutrition (TPN)
Any concomitant or prior invasive malignancies with the following curatively treated exceptions:
Treated limited stage basal cell or squamous cell carcinoma of the skin
Carcinoma in situ of the breast or cervix
Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous/serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
Prior cancer treated with a curative intent with no evidence of recurrent disease 3 years following diagnosis and judged by the investigator to be at low risk of recurrence
Patients with any of the following:
History of myocardial infarction within six months
Unstable angina
Resting electrocardiogram (ECG) with clinically significant abnormal findings
New York Heart Association (NYHA) classification of III or IV
If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines
Patients with the following risk factors should have a baseline cardiac function assessment:
Prior treatment with anthracyclines
Prior treatment with trastuzumab
Prior central thoracic radiation therapy (RT), including RT to the heart
History of myocardial infarction within 6 to 12 months (patients with history of myocardial infarction within 6 months are excluded from the study)
Prior history of impaired cardiac function
History of stroke or transient ischemic attack within six months
Any prior history of hypertensive crisis or hypertensive encephalopathy
Clinically significant peripheral vascular disease or vascular disease (including aortic aneurysm or aortic dissection)
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (other than atrial fibrillation with controlled ventricular rate), or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because cediranib and olaparib are agents with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with cediranib and olaparib, breastfeeding should be discontinued if the mother is treated with cediranib or olaparib; these potential risks may also apply to other agents used in this study
Known HIV-positive individuals are ineligible because of the potential for pharmacokinetic interactions with cediranib or olaparib; in addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy
Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies as they may interfere with the effectiveness of the study treatments
No features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated
No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce F Liu
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of South Alabama Mitchell Cancer Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36688
Country
United States
Facility Name
Alaska Women's Cancer Care
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Arizona Oncology Associates-West Orange Grove
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Arizona Oncology Associates-Wilmot
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
PCR Oncology
City
Arroyo Grande
State/Province
California
ZIP/Postal Code
93420
Country
United States
Facility Name
Mercy San Juan Medical Center
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Marin Cancer Care Inc
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Palo Alto Medical Foundation-Camino Division
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Palo Alto Medical Foundation-Gynecologic Oncology
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Kaiser Permanente-Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Palo Alto Medical Foundation Health Care
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
Facility Name
Sutter Roseville Medical Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Mercy Cancer Center - Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Sutter Medical Center Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente - Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
California Pacific Medical Center-Pacific Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente-San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
UCSF Medical Center-Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Pacific Central Coast Health Center-San Luis Obispo
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
Kaiser Permanente Medical Center - Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Palo Alto Medical Foundation-Santa Cruz
City
Santa Cruz
State/Province
California
ZIP/Postal Code
95065
Country
United States
Facility Name
Sutter Pacific Medical Foundation
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Palo Alto Medical Foundation-Sunnyvale
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94086
Country
United States
Facility Name
Kaiser Permanente-Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Kaiser Permanente-Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Woodland Memorial Hospital
City
Woodland
State/Province
California
ZIP/Postal Code
95695
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
UCHealth University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Penrose-Saint Francis Healthcare
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
UCHealth Memorial Hospital Central
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Kaiser Permanente-Franklin
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Rose
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
Kaiser Permanente-Rock Creek
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Littleton
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Kaiser Permanente-Lone Tree
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Sky Ridge
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
SCL Health Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Smilow Cancer Hospital Care Center-Fairfield
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Smilow Cancer Hospital Care Center at Saint Francis
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Middlesex Hospital
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
The Hospital of Central Connecticut
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Smilow Cancer Hospital-Torrington Care Center
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
Smilow Cancer Hospital Care Center-Trumbull
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Christiana Care Health System-Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Beebe Health Campus
City
Rehoboth Beach
State/Province
Delaware
ZIP/Postal Code
19971
Country
United States
Facility Name
TidalHealth Nanticoke / Allen Cancer Center
City
Seaford
State/Province
Delaware
ZIP/Postal Code
19973
Country
United States
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
University of Florida Health Science Center - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University Cancer and Blood Center LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Dekalb Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Medical Center of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Saint Alphonsus Cancer Care Center-Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Saint Luke's Cancer Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Saint Luke's Cancer Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Facility Name
Saint Luke's Cancer Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saint Luke's Cancer Institute - Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Rush - Copley Medical Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Illinois CancerCare-Bloomington
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Illinois CancerCare-Canton
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Illinois CancerCare-Carthage
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Centralia Oncology Clinic
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
John H Stroger Jr Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Cancer Care Specialists of Illinois - Decatur
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Crossroads Cancer Center
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Illinois CancerCare-Eureka
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
NorthShore University HealthSystem-Evanston Hospital
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Illinois CancerCare-Galesburg
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Northwestern Medicine Cancer Center Delnor
City
Geneva
State/Province
Illinois
ZIP/Postal Code
60134
Country
United States
Facility Name
NorthShore University HealthSystem-Glenbrook Hospital
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
NorthShore University HealthSystem-Highland Park Hospital
City
Highland Park
State/Province
Illinois
ZIP/Postal Code
60035
Country
United States
Facility Name
Sudarshan K Sharma MD Limited-Gynecologic Oncology
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Illinois CancerCare-Kewanee Clinic
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
Illinois CancerCare-Macomb
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Cancer Care Center of O'Fallon
City
O'Fallon
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Facility Name
Illinois CancerCare-Ottawa Clinic
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Illinois CancerCare-Pekin
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Illinois CancerCare-Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Illinois CancerCare-Peru
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois CancerCare-Princeton
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Facility Name
Northwestern Medicine Cancer Center Warrenville
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Facility Name
Ascension Saint Vincent Indianapolis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Medical Oncology and Hematology Associates-West Des Moines
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Mercy Cancer Center-West Lakes
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mission Cancer and Blood - Laurel
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Mercy Medical Center-West Lakes
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Ascension Via Christi - Pittsburg
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Cotton O'Neil Cancer Center / Stormont Vail Health
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Associates In Womens Health
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Ascension Via Christi Hospitals Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
University of Kentucky/Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Norton Hospital Pavilion and Medical Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Norton Suburban Hospital and Medical Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Norton Brownsboro Hospital and Medical Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Mary Bird Perkins Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Woman's Hospital
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70817
Country
United States
Facility Name
Women's Cancer Care-Covington
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Ochsner Medical Center Jefferson
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Lafayette Family Cancer Center-EMMC
City
Brewer
State/Province
Maine
ZIP/Postal Code
04412
Country
United States
Facility Name
Maine Medical Center- Scarborough Campus
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Johns Hopkins University/Sidney Kimmel Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Maryland Shore Medical Center at Easton
City
Easton
State/Province
Maryland
ZIP/Postal Code
21601
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lahey Hospital and Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Cancer Institute-Downriver
City
Brownstown
State/Province
Michigan
ZIP/Postal Code
48183
Country
United States
Facility Name
Henry Ford Macomb Hospital-Clinton Township
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Green Bay Oncology - Escanaba
City
Escanaba
State/Province
Michigan
ZIP/Postal Code
49829
Country
United States
Facility Name
Weisberg Cancer Treatment Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Spectrum Health at Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Green Bay Oncology-Manistique
City
Manistique
State/Province
Michigan
ZIP/Postal Code
49854
Country
United States
Facility Name
Saint Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Ascension Providence Hospitals - Southfield
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Henry Ford West Bloomfield Hospital
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Sanford Joe Lueken Cancer Center
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mayo Clinic Health Systems-Mankato
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56001
Country
United States
Facility Name
Fairview Clinics and Surgery Center Maple Grove
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55369
Country
United States
Facility Name
Saint John's Hospital - Healtheast
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
University of Minnesota/Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Park Nicollet Clinic - Saint Louis Park
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Saint Francis Regional Medical Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Minnesota Oncology Hematology PA-Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Saint Dominic-Jackson Memorial Hospital
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Mercy Hospital Joplin
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Benefis Healthcare- Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Community Medical Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
CHI Health Saint Francis
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
CHI Health Good Samaritan
City
Kearney
State/Province
Nebraska
ZIP/Postal Code
68847
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Alegent Health Bergan Mercy Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Alegent Health Lakeside Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Women's Cancer Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Wentworth-Douglass Hospital
City
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Dartmouth Cancer Center - Nashua
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03063
Country
United States
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Cooper Hospital University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
MD Anderson Cancer Center at Cooper-Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Southwest Gynecologic Oncology Associates Inc
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Memorial Medical Center - Las Cruces
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
Montefiore Medical Center-Einstein Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
State University of New York Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Facility Name
Dickstein Cancer Treatment Center
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Southeastern Medical Oncology Center-Goldsboro
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Southeastern Medical Oncology Center-Jacksonville
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
FirstHealth of the Carolinas-Moore Regional Hospital
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
Duke Raleigh Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Novant Health New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Sanford Bismarck Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Sanford Broadway Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Sanford Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Trinity Cancer Care Center
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Facility Name
Summa Health System - Akron Campus
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Cleveland Clinic Akron General
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
UHHS-Chagrin Highlands Medical Center
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
University of Cincinnati Cancer Center-UC Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Good Samaritan Hospital - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
TriHealth Cancer Institute-Westside
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45247
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic Cancer Center/Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Columbus Oncology and Hematology Associates Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
The Mark H Zangmeister Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Orion Cancer Care
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Hillcrest Hospital Cancer Center
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
UH Seidman Cancer Center at Lake Health Mentor Campus
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
ProMedica Flower Hospital
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
University Hospitals Sharon Health Center
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
UHHS-Westlake Medical Center
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Wright-Patterson Medical Center
City
Wright-Patterson Air Force Base
State/Province
Ohio
ZIP/Postal Code
45433
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute-Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Saint Charles Health System
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Willamette Valley Cancer Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Legacy Mount Hood Medical Center
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Legacy Good Samaritan Hospital and Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Kaiser Permanente Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Legacy Meridian Park Hospital
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Jefferson Abington Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Saint Luke's University Hospital-Bethlehem Campus
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Ephrata Cancer Center
City
Ephrata
State/Province
Pennsylvania
ZIP/Postal Code
17522
Country
United States
Facility Name
Adams Cancer Center
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
University of Pennsylvania/Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
University of Pittsburgh Cancer Institute (UPCI)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Guthrie Medical Group PC-Robert Packer Hospital
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Geisinger Medical Oncology-Selinsgrove
City
Selinsgrove
State/Province
Pennsylvania
ZIP/Postal Code
17870
Country
United States
Facility Name
Reading Hospital
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
UPMC Susquehanna
City
Williamsport
State/Province
Pennsylvania
ZIP/Postal Code
17701
Country
United States
Facility Name
WellSpan Health-York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
AnMed Health Cancer Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Gibbs Cancer Center-Gaffney
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29341
Country
United States
Facility Name
Saint Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Prisma Health Cancer Institute - Faris
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Saint Francis Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Gibbs Cancer Center-Pelham
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
South Carolina Cancer Specialists PC
City
Hilton Head Island
State/Province
South Carolina
ZIP/Postal Code
29926-3827
Country
United States
Facility Name
Spartanburg Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
MGC Hematology Oncology-Union
City
Union
State/Province
South Carolina
ZIP/Postal Code
29379
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Sanford Cancer Center Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Facility Name
Wellmont Medical Associates Oncology and Hematology-Johnson City
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Ballad Health Cancer Care - Kingsport
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Wellmont Holston Valley Hospital and Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Thompson Cancer Survival Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Thompson Cancer Survival Center - West
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37932
Country
United States
Facility Name
Vanderbilt University/Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Oncology - Central Austin Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology - South Austin Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Texas Oncology Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
UT Southwestern/Simmons Cancer Center-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Oncology - Fort Worth Cancer Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Methodist Willowbrook Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Houston Methodist Sugar Land Hospital
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Texas Oncology-The Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Saint George Regional Medical Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Utah Cancer Specialists-Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Skagit Regional Health Cancer Care Center
City
Mount Vernon
State/Province
Washington
ZIP/Postal Code
98274
Country
United States
Facility Name
Skagit Valley Hospital
City
Mount Vernon
State/Province
Washington
ZIP/Postal Code
98274
Country
United States
Facility Name
Pacific Gynecology Specialists
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
FHCC South Lake Union
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University of Washington Medical Center - Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Women's Cancer Center of Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
University of Washington Medical Center - Montlake
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Legacy Salmon Creek Hospital
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98686
Country
United States
Facility Name
Wenatchee Valley Hospital and Clinics
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
West Virginia University Charleston Division
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Edwards Comprehensive Cancer Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Marshfield Clinic-Chippewa Center
City
Chippewa Falls
State/Province
Wisconsin
ZIP/Postal Code
54729
Country
United States
Facility Name
Marshfield Clinic Cancer Center at Sacred Heart
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Facility Name
Saint Vincent Hospital Cancer Center Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Saint Vincent Hospital Cancer Center at Saint Mary's
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Marshfield Clinic - Ladysmith Center
City
Ladysmith
State/Province
Wisconsin
ZIP/Postal Code
54848
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Saint Vincent Hospital Cancer Center at Marinette
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Marshfield Medical Center-Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Marshfield Clinic-Minocqua Center
City
Minocqua
State/Province
Wisconsin
ZIP/Postal Code
54548
Country
United States
Facility Name
ProHealth D N Greenwald Center
City
Mukwonago
State/Province
Wisconsin
ZIP/Postal Code
53149
Country
United States
Facility Name
ProHealth Oconomowoc Memorial Hospital
City
Oconomowoc
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Facility Name
Saint Vincent Hospital Cancer Center at Oconto Falls
City
Oconto Falls
State/Province
Wisconsin
ZIP/Postal Code
54154
Country
United States
Facility Name
Marshfield Medical Center-Rice Lake
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States
Facility Name
Ascension Saint Michael's Hospital
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54481
Country
United States
Facility Name
Marshfield Medical Center-River Region at Stevens Point
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54482
Country
United States
Facility Name
Saint Vincent Hospital Cancer Center at Sturgeon Bay
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235-1495
Country
United States
Facility Name
ProHealth Waukesha Memorial Hospital
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
UW Cancer Center at ProHealth Care
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Marshfield Clinic-Wausau Center
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Marshfield Medical Center - Weston
City
Weston
State/Province
Wisconsin
ZIP/Postal Code
54476
Country
United States
Facility Name
Marshfield Clinic - Wisconsin Rapids Center
City
Wisconsin Rapids
State/Province
Wisconsin
ZIP/Postal Code
54494
Country
United States
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Juravinski Cancer Centre at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Ottawa Hospital and Cancer Center-General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Algoma District Cancer Program Sault Area Hospital
City
Sault Ste Marie
State/Province
Ontario
ZIP/Postal Code
P6B 0A8
Country
Canada
Facility Name
Odette Cancer Centre- Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network-Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
CHUM - Hopital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
CHUM - Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Iwate Medical University Hospital
City
Shiwa-gun
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
Kagoshima City Hospital
City
Kagoshima City
State/Province
Kagoshima
ZIP/Postal Code
890-8760
Country
Japan
Facility Name
The Cancer Institute Hospital Of JFCR
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104 0045
Country
Japan
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
35290101
Citation
Liu JF, Brady MF, Matulonis UA, Miller A, Kohn EC, Swisher EM, Cella D, Tew WP, Cloven NG, Muller CY, Bender DP, Moore RG, Michelin DP, Waggoner SE, Geller MA, Fujiwara K, D'Andre SD, Carney M, Alvarez Secord A, Moxley KM, Bookman MA. Olaparib With or Without Cediranib Versus Platinum-Based Chemotherapy in Recurrent Platinum-Sensitive Ovarian Cancer (NRG-GY004): A Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2022 Jul 1;40(19):2138-2147. doi: 10.1200/JCO.21.02011. Epub 2022 Mar 15.
Results Reference
derived
PubMed Identifier
35170751
Citation
Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
Results Reference
derived
Learn more about this trial
Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
We'll reach out to this number within 24 hrs