Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma
About this trial
This is an interventional treatment trial for Fallopian Tube Endometrioid Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Primary Surgery and Neoadjuvant Chemotherapy with Interval Cytoreductive Surgery Patients:
Patients must have measurable disease; at least one target lesion must have a minimum length of 1 cm in both the long and short axis (determined at the local site); for primary surgery patients, if no radiographic evidence of measurable disease is obtained prior to registration this can be based on surgical findings; imaging then would need to be completed in the 14 days between Gynecology Oncology Group (GOG) registration and chemotherapy initiation
- After GOG registration, the American College of Radiology [ACR] Imaging Core Laboratory will confirm target lesion as required per protocol; the GOG-eligibility (RECIST) scan and baseline T0 perfusion CT scans will be reviewed prior to the intermediate T1 perfusion CT time point
- Primary Surgery Patients:
- Patients with a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma or fallopian tube cancer, stage II -IV suboptimally debulked (any residual disease > 1 cm); International Federation of Gynecology and Obstetrics (FIGO) stage is assessed following the completion of initial abdominal surgery, appropriate imaging studies and with appropriate tissue available for histologic evaluation; the minimum surgery required is an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the GOG Surgical Procedures Manual
- Neoadjuvant Chemotherapy (NAC) with Interval Cytoreductive Surgery (ICS) Patients:
- For patients undergoing NAC-ICS, a core tissue (not fine needle aspiration) biopsy is required; the tissue must be consistent with a Müllerian origin; patients will require documentation of at least stage II or extraovarian sites of disease acquired via imaging or surgery (without attempt at cytoreduction)
- Patients with the following histologic epithelial cell types are eligible: serous, endometrioid, clear cell, mucinous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma; patients may have co-existing fallopian tube carcinoma in-situ so long as the primary origin of invasive tumor is ovarian, peritoneal or fallopian tube; of note, patients with clear cell and mucinous tumors will be eligible unless there is a higher priority protocol
- Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl; this ANC cannot have been induced or supported by granulocyte colony stimulating factors
- Platelets greater than or equal to 100,000/mcl
- Creatinine =< 1.5 x institutional upper limit normal (ULN)
- Bilirubin less than or equal to 1.5 x ULN
- Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 x ULN
- Alkaline phosphatase less than or equal to 2.5 x ULN
- Neuropathy (sensory or motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) grade 1
- Patients must have a GOG performance status of 0, 1, or 2
- Patients must be entered within 12 weeks of diagnostic/staging surgery
- Patients who have met the pre-entry requirements
- An approved informed consent and authorization permitting release of personal health information and must be signed by the patient or guardian
Only applies for patients who elect to receive bevacizumab:
- Patients in this trial may receive ovarian estrogen +/- progestin replacement therapy as indicated at the lowest effective dose(s) for control of menopausal symptoms at any time, but not high-dose progestins for management of anorexia while on protocol-directed therapy or prior to disease progression due to thrombophlebitis risk
- Prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a partial prothrombin time (PTT) < 1.2 times the upper limit of normal; (heparin, lovenox or alternative anticoagulants are acceptable)
- All patients enrolled into GOG-0262 at sites where ACRIN 6695 is open will be enrolled in the advanced imaging protocol; patients receiving adjuvant or neoadjuvant chemotherapy are eligible for ACRIN 6695; the following sentence does not apply to those patients entered after 02/08/2012: if a patient declines to participate in the perfusion imaging portion of the protocol, a clinical rationale for declination of imaging form will be completed as part of the data submission for ACRIN 6695
ACRIN 6695 Eligible Patients:
- Confirmation of ACRIN 6695 eligibility after the baseline T0 perfusion computed tomography (CT) will be assessed by the ACR Imaging Core Lab: At least one target lesion must have a minimum length of 1 cm in both the long and short axis (as determined by the local site), at least half of the target lesion must have attenuation greater than or equal to 10 Hounsfield Units (HU) on the unenhanced CT, and at least half of the lesion must have maximum enhancement greater than or equal to 5 HU in the perfusion CT scan (as determined by the ACR Imaging Core Lab)
Exclusion Criteria:
- Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only (such as patients with stage I-A or I-B low grade epithelial ovarian or fallopian tube cancers) are not eligible; patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian, peritoneal primary or fallopian tube cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
- Patients who have received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or fallopian tube cancer; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
- Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer
- Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, unless all of the following conditions are met: stage not greater than I-A, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO grade 3 lesions
- With the exception of non-melanoma skin cancer, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy
- Patients with acute hepatitis or active infection that requires parenteral antibiotics
Patients with clinically significant cardiovascular disease; this includes:
- Myocardial infarction or unstable angina < 6 months prior to registration
- New York Heart Association (NYHA) grade II or greater congestive heart failure
- Serious cardiac arrhythmia requiring medication; this does not include asymptomatic, atrial fibrillation with controlled ventricular rate
- Patients who are pregnant or nursing; patients of childbearing potential must agree to use contraceptive measures during study therapy and for at least six months after completion of bevacizumab therapy
- Patients who have received prior therapy with any anti-vascular endothelial growth factor (VEGF) drug, including bevacizumab
- Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study; the investigator should feel free to consult the Statistical and Data Center (SDC) randomization desk for uncertainty in this regard
- Patients with known allergy to cremophor or polysorbate 80
- Only applies to patients who elect to receive bevacizumab:
- Patients with serious non-healing wound, ulcer, or bone fracture; this includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations
- Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study
- Patients with CTCAE grade 2 or greater peripheral vascular disease (at least brief [< 24 hours] episodes of ischemia managed non-surgically and without permanent deficit)
- Patients with a history of CVA within six months
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
- Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection; specifically, a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24-hour urine collection; obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24-hour urine); send sample to lab with request for urine protein and creatinine levels (separate requests); the lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL); the UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR < 1.0 to allow participation in the study
Patients with or with anticipation of invasive procedures as defined below:
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of bevacizumab therapy (cycle 2)
- Major surgical procedure anticipated during the course of the study; this includes, but is not limited to abdominal surgery (laparotomy or laparoscopy) prior to disease progression such as colostomy or enterostomy reversal, secondary cytoreductive surgery, or second look surgery; please consult with the SDC Randomization Desk prior to patient entry for any questions related to the classification of surgical procedures
- Any tissue biopsy, such as a core biopsy, within 7 days prior to the first date of bevacizumab therapy (cycle 2)
- Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition
- Patients with metastasis tumor in the parenchyma of the liver or lungs with proximity to large vessels which could make the patients at high risk of lethal hemorrhage during treatment with bevacizumab (ie. hemoptysis, liver rupture)
ACRIN 6695 Ineligible Patients:
- Patients with contraindication to iodinated contrast for perfusion CT imaging
- Patients who receive Metformin within 48 hours before perfusion CT imaging
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- University of South Alabama Mitchell Cancer Institute
- Providence Alaska Medical Center
- Saint Joseph's Hospital and Medical Center
- Mayo Clinic in Arizona
- University of Arizona Cancer Center-Orange Grove Campus
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- CHI Saint Vincent Cancer Center Hot Springs
- University of Arkansas for Medical Sciences
- Kaiser Permanente-Deer Valley Medical Center
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- East Bay Radiation Oncology Center
- Valley Medical Oncology Consultants-Castro Valley
- John Muir Medical Center-Concord Campus
- Bay Area Breast Surgeons Inc
- Kaiser Permanente-Fremont
- Valley Medical Oncology Consultants-Fremont
- Kaiser Permanente-Fresno
- Marin Cancer Care Inc
- UC San Diego Moores Cancer Center
- Long Beach Memorial Medical Center-Todd Cancer Institute
- Kaiser Permanente Los Angeles Medical Center
- Cedars Sinai Medical Center
- UCLA / Jonsson Comprehensive Cancer Center
- Contra Costa Regional Medical Center
- El Camino Hospital
- Palo Alto Medical Foundation-Gynecologic Oncology
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Tom K Lee Inc
- Kaiser Permanente Oakland-Broadway
- Kaiser Permanente-Oakland
- Stanford Cancer Institute Palo Alto
- Kaiser Permanente-Rancho Cordova Cancer Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Rohnert Park Cancer Center
- Kaiser Permanente-Roseville
- Sutter Roseville Medical Center
- The Permanente Medical Group-Roseville Radiation Oncology
- Sutter Medical Center Sacramento
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-South Sacramento
- South Sacramento Cancer Center
- Kaiser Permanente - Sacramento
- Sharp Memorial Hospital
- Kaiser Permanente-San Francisco
- UCSF Medical Center-Mount Zion
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente Cancer Treatment Center
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Olive View-University of California Los Angeles Medical Center
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- John Muir Medical Center-Walnut Creek
- UCHealth University of Colorado Hospital
- Kaiser Permanente-Franklin
- Rocky Mountain Gynecologic Oncology PC
- Poudre Valley Hospital
- Kaiser Permanente-Rock Creek
- Hartford HealthCare - Saint Vincent's Medical Center
- Danbury Hospital
- Hartford Hospital
- Smilow Cancer Hospital Care Center at Saint Francis
- The Hospital of Central Connecticut
- Yale University
- Eastern Connecticut Hematology and Oncology Associates
- Stamford Hospital/Bennett Cancer Center
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- MedStar Washington Hospital Center
- Sibley Memorial Hospital
- Morton Plant Hospital
- Broward Health Medical Center
- Florida Gynecologic Oncology
- Southeast Gynecologic Oncology Associates
- Mayo Clinic in Florida
- The Watson Clinic
- AdventHealth Orlando
- Orlando Health Cancer Institute
- Women's Cancer Associates
- Northside Hospital
- Northeast Georgia Medical Center-Gainesville
- Central Georgia Gynecologic Oncology
- Memorial Health University Medical Center
- Pali Momi Medical Center
- Hawaii Cancer Care Inc - Waterfront Plaza
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Kaiser Permanente Moanalua Medical Center
- Kapiolani Medical Center for Women and Children
- Wilcox Memorial Hospital and Kauai Medical Clinic
- Maui Memorial Medical Center
- Pacific Cancer Institute of Maui
- Saint Alphonsus Cancer Care Center-Boise
- Kootenai Clinic Cancer Services - Post Falls
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Graham Hospital Association
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Memorial Hospital
- Northwestern University
- John H Stroger Jr Hospital of Cook County
- Rush University Medical Center
- Presence Resurrection Medical Center
- University of Chicago Comprehensive Cancer Center
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Elmhurst Memorial Hospital
- Eureka Hospital
- Illinois CancerCare-Eureka
- Illinois CancerCare-Galesburg
- Illinois CancerCare-Havana
- Mason District Hospital
- Sudarshan K Sharma MD Limited-Gynecologic Oncology
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Mcdonough District Hospital
- Loyola University Medical Center
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Trinity Medical Center
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Bromenn Regional Medical Center
- Carle Cancer Institute Normal
- Illinois CancerCare-Community Cancer Center
- Advocate Christ Medical Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Advocate Lutheran General Hospital
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Proctor Hospital
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Illinois CancerCare-Princeton
- Perry Memorial Hospital
- Illinois CancerCare-Spring Valley
- Memorial Medical Center
- Carle Cancer Center
- Northwestern Medicine Cancer Center Warrenville
- Northwestern Medicine Central DuPage Hospital
- Franciscan Saint Francis Health-Beech Grove
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Indiana University/Melvin and Bren Simon Cancer Center
- Ascension Saint Vincent Indianapolis Hospital
- Community Howard Regional Health
- IU Health La Porte Hospital
- Franciscan Saint Anthony Health-Michigan City
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- The Community Hospital
- Michiana Hematology Oncology PC-Plymouth
- Reid Health
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- Michiana Hematology Oncology PC-Westville
- McFarland Clinic - Ames
- Constantinou, Costas L MD (UIA Investigator)
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- University of Iowa/Holden Comprehensive Cancer Center
- Mercy Medical Center - North Iowa
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- University of Kansas Cancer Center
- Menorah Medical Center
- Saint Luke's South Hospital
- Kansas City NCI Community Oncology Research Program
- Saint Elizabeth Healthcare Edgewood
- Baptist Health Lexington
- University of Kentucky/Markey Cancer Center
- Norton Hospital Pavilion and Medical Campus
- The James Graham Brown Cancer Center at University of Louisville
- Pikeville Medical Center
- Woman's Hospital
- Louisiana State University Health Science Center
- Tulane University Health Sciences Center
- University Medical Center New Orleans
- Ochsner Medical Center Jefferson
- LSU Health Sciences Center at Shreveport
- Highland Clinic
- Eastern Maine Medical Center
- Maine Medical Center-Bramhall Campus
- University of Maryland/Greenebaum Cancer Center
- Greater Baltimore Medical Center
- Sinai Hospital of Baltimore
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- Johns Hopkins University/Sidney Kimmel Cancer Center
- University of Maryland Shore Medical Center at Easton
- Christiana Care - Union Hospital
- Holy Cross Hospital
- Sturdy Memorial Hospital
- Tufts Medical Center
- Massachusetts General Hospital Cancer Center
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- Lahey Hospital and Medical Center
- Holy Family Hospital
- Baystate Medical Center
- UMass Memorial Medical Center - Memorial Division
- Michigan Cancer Research Consortium NCORP
- Saint Joseph Mercy Hospital
- Bronson Battle Creek
- Spectrum Health Big Rapids Hospital
- Beaumont Hospital - Dearborn
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Ascension Saint John Hospital
- Green Bay Oncology - Escanaba
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- Genesys Regional Medical Center
- Cancer Research Consortium of West Michigan NCORP
- Spectrum Health at Butterworth Campus
- Trinity Health Grand Rapids Hospital
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Trinity Health Saint Mary Mercy Livonia Hospital
- Trinity Health Muskegon Hospital
- Lakeland Hospital Niles
- Saint Joseph Mercy Oakland
- Lake Huron Medical Center
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Ascension Providence Hospitals - Southfield
- Munson Medical Center
- Saint John Macomb-Oakland Hospital
- University of Michigan Health - West
- Sanford Joe Lueken Cancer Center
- Essentia Health Saint Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Saint Luke's Hospital of Duluth
- Fairview Southdale Hospital
- Lake Region Healthcare Corporation-Cancer Care
- Unity Hospital
- Hutchinson Area Health Care
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- New Ulm Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in Rochester
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Park Nicollet Frauenshuh Cancer Center
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Saint Dominic-Jackson Memorial Hospital
- University of Mississippi Medical Center
- Freeman Health System
- Saint Luke's Hospital of Kansas City
- Saint Joseph Health Center
- North Kansas City Hospital
- Heartland Hematology and Oncology Associates Incorporated
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Heartland Regional Medical Center
- Saint Joseph Oncology Inc
- Washington University School of Medicine
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Montana Cancer Consortium NCORP
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- CHI Health Good Samaritan
- Nebraska Cancer Research Center
- Missouri Valley Cancer Consortium
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- University of Nebraska Medical Center
- Women's Cancer Center of Nevada
- Center of Hope at Renown Medical Center
- Renown Regional Medical Center
- Cooper Hospital University Medical Center
- Hackensack University Medical Center
- Morristown Medical Center
- Virtua Memorial
- Jersey Shore Medical Center
- Saint Luke's Hospital-Warren Campus
- Valley Hospital
- Overlook Hospital
- Inspira Medical Center Vineland
- Virtua Voorhees
- University of New Mexico Cancer Center
- Southwest Gynecologic Oncology Associates Inc
- Memorial Medical Center - Las Cruces
- Women's Cancer Care Associates LLC
- Island Gynecologic Oncology
- Montefiore Medical Center-Einstein Campus
- State University of New York Downstate Medical Center
- Roswell Park Cancer Institute
- Queens Hospital Center
- Northwell Health/Center for Advanced Medicine
- North Shore University Hospital
- Garnet Health Medical Center
- NYU Winthrop Hospital
- Long Island Jewish Medical Center
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
- Memorial Sloan Kettering Cancer Center
- Staten Island University Hospital
- Stony Brook University Medical Center
- State University of New York Upstate Medical University
- Hope Women's Cancer Centers-Asheville
- Cone Health Cancer Center at Alamance Regional
- UNC Lineberger Comprehensive Cancer Center
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Presbyterian Medical Center
- Duke University Medical Center
- Wayne Memorial Hospital
- Margaret R Pardee Memorial Hospital
- FirstHealth of the Carolinas-Moore Regional Hospital
- Rutherford Hospital
- Novant Health New Hanover Regional Medical Center
- Wake Forest University Health Sciences
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Sanford Broadway Medical Center
- Sanford Clinic North-Fargo
- Sanford Roger Maris Cancer Center
- Summa Health System - Akron Campus
- Cleveland Clinic Akron General
- Mary Rutan Hospital
- Aultman Health Foundation
- Adena Regional Medical Center
- University of Cincinnati Cancer Center-UC Medical Center
- Good Samaritan Hospital - Cincinnati
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Miami Valley Hospital North
- Dayton NCI Community Oncology Research Program
- Grady Memorial Hospital
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Wayne Hospital
- Kettering Medical Center
- Fairfield Medical Center
- Saint Rita's Medical Center
- Marietta Memorial Hospital
- Hillcrest Hospital Cancer Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- Knox Community Hospital
- Licking Memorial Hospital
- Southern Ohio Medical Center
- Springfield Regional Medical Center
- Upper Valley Medical Center
- Saint Ann's Hospital
- Clinton Memorial Hospital
- Greene Memorial Hospital
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Oklahoma Cancer Specialists and Research Institute-Tulsa
- Saint Charles Health System
- Legacy Good Samaritan Hospital and Medical Center
- Compass Oncology Rose Quarter
- Oregon Health and Science University
- Jefferson Abington Hospital
- Lehigh Valley Hospital-Cedar Crest
- Saint Luke's University Hospital-Bethlehem Campus
- Bryn Mawr Hospital
- Delaware County Memorial Hospital
- Penn State Milton S Hershey Medical Center
- Lancaster General Hospital
- Paoli Memorial Hospital
- University of Pennsylvania/Abramson Cancer Center
- Pennsylvania Hospital
- Fox Chase Cancer Center
- Temple University Hospital
- Phoenixville Hospital
- UPMC-Magee Womens Hospital
- West Penn Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- Mercy Hospital
- Hematology and Oncology Associates of North East Pennsylvania
- Scranton Hematology Oncology
- Associates In Hematology Oncology PC-Upland
- Chester County Hospital
- Reading Hospital
- Lankenau Medical Center
- Main Line Health NCORP
- Women and Infants Hospital
- AnMed Health Cancer Center
- AnMed Health Hospital
- Prisma Health Cancer Institute - Spartanburg
- Medical University of South Carolina
- Saint Francis Hospital
- Prisma Health Cancer Institute - Faris
- Prisma Health Cancer Institute - Eastside
- Spartanburg Medical Center
- Black Hills Obstetrics and Gynecology
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Wellmont Holston Valley Hospital and Medical Center
- University of Tennessee - Knoxville
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Brooke Army Medical Center
- University of Texas Medical Branch
- Lyndon Baines Johnson General Hospital
- Houston Methodist Hospital
- M D Anderson Cancer Center
- Scott and White Memorial Hospital
- American Fork Hospital / Huntsman Intermountain Cancer Center
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Saint George Regional Medical Center
- Intermountain Health Care
- Utah Cancer Specialists-Salt Lake City
- Huntsman Cancer Institute/University of Utah
- LDS Hospital
- University of Vermont Medical Center
- Northern Virginia Pelvic Surgery Associates
- University of Virginia Cancer Center
- Danville Regional Medical Center
- Hematology Oncology Associates of Fredericksburg Inc
- Virginia Oncology Associates-Hampton
- Centra Lynchburg Hematology-Oncology Clinic Inc
- Virginia Oncology Associates - Lake Wright
- Southwest VA Regional Cancer Center
- Virginia Commonwealth University/Massey Cancer Center
- Carilion Clinic Gynecological Oncology
- PeaceHealth Medical Group PC
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Providence Regional Cancer Partnership
- Skagit Regional Health Cancer Care Center
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Virginia Mason Medical Center
- Pacific Gynecology Specialists
- FHCC South Lake Union
- Fred Hutchinson Cancer Research Center
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- University of Washington Medical Center - Northwest
- University of Washington Medical Center - Montlake
- Olympic Medical Cancer Care Center
- Cancer Care Northwest - Spokane South
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
- MultiCare Tacoma General Hospital
- Saint Joseph Medical Center
- Providence Saint Mary Regional Cancer Center
- Wenatchee Valley Hospital and Clinics
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Langlade Hospital and Cancer Center
- ThedaCare Regional Cancer Center
- Marshfield Clinic-Chippewa Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital Cancer Center Green Bay
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Vincent Hospital Cancer Center at Saint Mary's
- Aurora BayCare Medical Center
- Gundersen Lutheran Medical Center
- University of Wisconsin Carbone Cancer Center
- Holy Family Memorial Hospital
- Bay Area Medical Center
- Marshfield Medical Center-Marshfield
- Aurora Saint Luke's Medical Center
- Medical College of Wisconsin
- Aurora Sinai Medical Center
- Marshfield Clinic-Minocqua Center
- ProHealth D N Greenwald Center
- ProHealth Oconomowoc Memorial Hospital
- Saint Vincent Hospital Cancer Center at Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- Ascension Saint Mary's Hospital
- Marshfield Medical Center-Rice Lake
- Vince Lombardi Cancer Clinic-Sheboygan
- Ascension Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- ProHealth Waukesha Memorial Hospital
- Aspirus Regional Cancer Center
- Aurora West Allis Medical Center
- Diagnostic and Treatment Center
- Marshfield Medical Center - Weston
- Marshfield Clinic - Wisconsin Rapids Center
- Rocky Mountain Oncology
- Welch Cancer Center
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
- Asan Medical Center
- Gangnam Severance Hospital
- Seoul National University Hospital
- Yongdong Severence Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (adjuvant chemotherapy suboptimally debulked)
Arm II (neoadjuvant chemotherapy)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.