Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma
About this trial
This is an interventional treatment trial for Fallopian Tube Clear Cell Adenocarcinoma
Eligibility Criteria
Inclusion Criteria: Patients with a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma or fallopian tube cancer; International Federation of Gynecology and Obstetrics (FIGO) stage III with any gross (macroscopic or palpable) residual disease or FIGO stage IV, defined surgically at the completion of initial abdominal surgery and with appropriate tissue available for histologic evaluation; the minimum surgery required was an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage, as well as a maximal effort at tumor debulking; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual; however, the surgeon is not required to have performed all of the items contained in this section of the GOG Surgical Procedures Manual; those patients with stage III cancer in which the largest maximal diameter of any residual tumor implant at the completion of this initial surgery is no greater than 1 cm will be defined as "optimal;" all others will be defined as "suboptimal;" measurable disease on post-operative imaging studies is not required for eligibility Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, 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; if doubt exists, it is recommended that the investigator should have the slides reviewed by an independent pathologist or, if necessary, the Pathology Co-Chair, prior to entry; 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 Absolute neutrophil count (ANC) greater than or equal to 1,500/µl equivalent to Common Toxicity Criteria for Adverse Events version (v)3.0 (CTCAE) grade 1; this ANC cannot have been induced or supported by granulocyte colony stimulating factors Platelets greater than or equal to 100,000/µl; (CTCAE grade 0-1) Creatinine =< 1.5 x institutional upper limit normal (ULN), CTCAE grade 1 Bilirubin less than or equal to 1.5 x ULN (CTCAE grade 1) Serum glutamic oxaloacetic transaminase (SGOT) and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1) Neuropathy (sensory and motor) less than or equal to CTCAE grade 1 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 thrombo-embolus) and a partial thromboplastin time (PTT) < 1.2 times the upper limit of normal Patients with a GOG Performance Status of 0, 1, or 2 Patients must be entered between 1 and 12 weeks after initial surgery performed for the combined purpose of diagnosis, staging and cytoreduction Patients with measurable and non-measurable disease are eligible; patients may or may not have cancer-related symptoms Patients who have met the pre-entry requirements An approved informed consent and authorization permitting release of personal health information must be signed by the patient or guardian 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 progestins for management of anorexia while on protocol directed therapy or prior to disease progression 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 Ia or Ib 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 are excluded; 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 are excluded; 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 or peritoneal primary cancer Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: stage not greater than I-B; 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 and other specific malignancies as noted above, 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 are excluded Patients with acute hepatitis or active infection that requires parenteral antibiotics 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 clinically significant cardiovascular disease; this includes: Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 90 mm Hg 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 CTCAE grade 2 or greater peripheral vascular disease (at least brief (< 24 hrs) episodes of ischemia managed non-surgically and without permanent deficit) 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/placebo 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, interval or secondary cytoreductive surgery, or second look surgery; please consult with the study chair prior to patient entry for any questions related to the classification of surgical procedures Core biopsy, within 7 days prior to the first date of bevacizumab/placebo therapy (cycle 2) Patients with GOG Performance Grade of 3 or 4 Patients who are pregnant or nursing; bevacizumab should not be administered to nursing women; 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 clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition 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 study chair or study co-chairs for uncertainty in this regard
Sites / Locations
- Northeast Alabama Regional Medical Center
- University of Alabama at Birmingham Cancer Center
- Clearview Cancer Institute
- Mobile Infirmary Medical Center
- Banner Thunderbird Medical Center
- Banner Desert Medical Center
- Banner Baywood Medical Center
- Banner Good Samaritan Medical Center
- Western Regional CCOP
- Mayo Clinic in Arizona
- Highlands Oncology Group PA - Fayetteville
- Washington Regional Medical Center - Fayetteville
- Mercy Hospital Fort Smith
- University of Arkansas for Medical Sciences
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- East Bay Radiation Oncology Center
- Eden Hospital Medical Center
- Valley Medical Oncology Consultants-Castro Valley
- John Muir Medical Center-Concord Campus
- Bay Area Breast Surgeons Inc
- Northbay Cancer Center
- Kaiser Permanente-Fremont
- Valley Medical Oncology Consultants-Fremont
- Cancer Care Associates of Fresno Medical Group Inc
- Saint Jude Medical Center
- Loma Linda University Medical 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
- 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
- UC Irvine Health/Chao Family Comprehensive Cancer Center
- Stanford Cancer Institute
- Valley Care Health System - Pleasanton
- Valley Medical Oncology Consultants
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Roseville
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Kaiser Permanente-San Diego Mission
- 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
- Cancer Center of Santa Barbara
- Santa Barbara Hematology Oncology Group Inc-Santa Barbara
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- John Muir Medical Center-Walnut Creek
- Colorado Gynecologic Oncology Group
- The Medical Center of Aurora
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Memorial Hospital Colorado Springs
- Porter Adventist Hospital
- Exempla Saint Joseph Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- Rose Medical Center
- Colorado Cancer Research Program CCOP
- Rocky Mountain Gynecologic Oncology PC
- Swedish Medical Center
- Poudre Valley Hospital
- Front Range Cancer Specialists
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Saint Anthony Hospital
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical Center
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- Hartford Hospital
- Saint Francis Hospital and Medical Center
- Manchester Memorial Hospital
- The Hospital of Central Connecticut
- Yale University
- Norwalk Hospital
- Stamford Hospital/Bennett Cancer Center
- Beebe Medical Center
- Christiana Gynecologic Oncology LLC
- Christiana Care Health System-Christiana Hospital
- Washington Hospital Center
- Morton Plant Hospital
- Holy Cross Hospital
- Lee Memorial Health System
- Florida Gynecologic Oncology
- Saint Vincent's Medical Center
- Mayo Clinic in Florida
- Jupiter Medical Center
- Mount Sinai Medical Center
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Florida Hospital Orlando
- UF Cancer Center at Orlando Health
- Bayfront Outpatient Health Clinic
- Sarasota Memorial Hospital
- Florida Cancer Specialists-West Palm Beach
- Phoebe Putney Memorial Hospital
- Grady Health System
- Emory University/Winship Cancer Institute
- Georgia Regents University Medical Center
- Northeast Georgia Medical Center
- Central Georgia Gynecologic Oncology
- Memorial University Medical Center
- Pali Momi Medical Center
- Oncare Hawaii Inc-POB II
- Queen's Medical Center
- Straub Clinic and Hospital
- University of Hawaii Cancer Center
- Oncare Hawaii Inc-Kuakini
- The Cancer Center of Hawaii-Liliha
- Kapiolani Medical Center for Women and Children
- Tripler Army Medical Center
- Maui Memorial Medical Center
- Pacific Cancer Institute of Maui
- Saint Luke's Mountain States Tumor Institute
- Saint Anthony's Health
- Northwest Community Hospital
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Graham Hospital Association
- Memorial Hospital
- Mount Sinai Hospital Medical Center
- Northwestern University
- Rush University Medical Center
- University of Illinois
- Swedish Covenant Hospital
- Presence Resurrection Medical Center
- University of Chicago Comprehensive Cancer Center
- Weiss Memorial Hospital
- Decatur Memorial Hospital
- Elmhurst Memorial Hospital
- Eureka Hospital
- NorthShore University HealthSystem-Evanston Hospital
- Saint Francis Hospital
- Galesburg Cottage Hospital
- Illinois CancerCare Galesburg
- Ingalls Memorial Hospital
- Mason District Hospital
- Hopedale Medical Complex - Hospital
- Joliet Oncology-Hematology Associates Limited
- Kewanee Hospital
- Mcdonough District Hospital
- Loyola University Medical Center
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Sharis, Christine M MD (UIA Investigator)
- Stoffel, Thomas J MD (UIA Investigator)
- Good Samaritan Regional Health Center
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Chicago Gynecologic Oncology SC
- Advocate Lutheran General Hospital
- Pekin Cancer Treatment Center
- Pekin Hospital
- Methodist Medical Center of Illinois
- Proctor Hospital
- Illinois CancerCare-Peoria
- Illinois Oncology Research Association CCOP
- OSF Saint Francis Medical Center
- Illinois Valley Hospital
- Perry Memorial Hospital
- Saint Anthony Medical Center
- Saint Margaret's Hospital
- Memorial Medical Center
- Carle Cancer Center
- Carle Clinic-Urbana Main
- Franciscan St. Francis Health-Beech Grove
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Indiana University/Melvin and Bren Simon Cancer Center
- Saint Vincent Hospital and Health Services
- Community Howard Regional Health
- IU Health La Porte Hospital
- Franciscan Saint Anthony Health-Michigan City
- Saint Joseph Regional Medical Center-Mishawaka
- The Community Hospital
- Reid Hospital and Health Care Services
- Memorial Hospital of South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium CCOP
- McFarland Clinic PC-William R Bliss Cancer Center
- Constantinou, Costas L MD (UIA Investigator)
- Cedar Rapids Oncology Association
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Genesis Medical Center - East Campus
- Genesis Medical Center - West Campus
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa Oncology Research Association CCOP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- University of Iowa/Holden Comprehensive Cancer Center
- Siouxland Regional Cancer Center
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Cedar Valley Medical Specialists
- Covenant Medical Center
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas-Independence
- Providence Medical Center
- University of Kansas Cancer Center
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas - Newton
- Menorah Medical Center
- Radiation Oncology Practice Corporation Southwest
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Shawnee Mission Medical Center-KCCC
- Stormont-Vail Regional Health Center
- Saint Francis Hospital and Medical Center - Topeka
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Main Office
- Via Christi Regional Medical Center
- Wichita CCOP
- Cancer Center of Kansas - Winfield
- University of Kentucky/Markey Cancer Center
- Norton Hospital Pavilion and Medical Campus
- The James Graham Brown Cancer Center at University of Louisville
- Tulane University Health Sciences Center
- Christus Schumpert Saint Mary's Place
- Eastern Maine Medical Center
- Maine Medical Center-Bramhall Campus
- Greater Baltimore Medical Center
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Memorial Hospital at Easton - Shore Regional Cancer Center
- The Memorial Hospital at Easton
- Union Hospital of Cecil County
- Associates in Oncology Hematology PC -Kensington
- Kaiser Permanente - Largo Medical Center
- Kaiser Permanente - Towson Medical Center
- Kaiser Permanente - Shady Grove Medical Center
- Maryland Oncology Hematology PA-Aquilino Cancer Center
- Holy Cross Hospital
- Berkshire Hematology Oncology PC
- Baystate Medical Center
- Commonwealth Hematology Oncology PC-Worcester
- University of Massachusetts Medical School
- Bixby Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium CCOP
- University of Michigan Comprehensive Cancer Center
- Bronson Battle Creek
- Spectrum Health Big Rapids Hospital
- Oakwood Hospital and Medical Center
- Wayne State University/Karmanos Cancer Institute
- Saint John Hospital and Medical Center
- Green Bay Oncology - Escanaba
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- Grand Rapids Clinical Oncology Program
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Spectrum Health-Blodgett Campus
- Gynecologic Oncology of West Michigan PLLC
- Holland Community Hospital
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Mercy Memorial Hospital
- Toledo Clinic Cancer Centers-Monroe
- Mercy Health Partners-Hackley Campus
- Mercy Health Mercy Campus
- McLaren-Northern Michigan
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- William Beaumont Hospital-Royal Oak
- Saint Mary's of Michigan
- Lakeland Hospital
- Providence Hospital-Southfield Cancer Center
- Munson Medical Center
- Saint John Macomb-Oakland Hospital
- Metro Health Hospital
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Fairview-Southdale Hospital
- Unity Hospital
- Minnesota Oncology Hematology PA-Maplewood
- Abbott-Northwestern Hospital
- University of Minnesota Medical Center-Fairview
- Hubert H Humphrey Cancer Center
- North Memorial Medical Health Center
- Mayo Clinic
- Metro-Minnesota NCI Community Oncology Research Program
- Park Nicollet Clinic - Saint Louis Park
- United Hospital
- Saint Francis Regional Medical Center
- Ridgeview Medical Center
- Minnesota Oncology and Hematology PA-Woodbury
- Saint Dominic-Jackson Memorial Hospital
- Singing River Hospital
- Southeast Missouri Hospital
- Saint Francis Medical Center
- University of Missouri - Ellis Fischel
- Centerpoint Medical Center LLC
- Capital Regional Medical Center
- Truman Medical Center
- Saint Luke's Cancer Institute
- Saint Luke's Hospital of Kansas City
- Radiation Oncology Practice Corporation South
- Saint Joseph Health Center
- North Kansas City Hospital
- Research Medical Center
- Radiation Oncology Practice Corporation - North
- Liberty Hospital
- Liberty Radiation Oncology Center
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Saint Louis University Hospital
- Washington University School of Medicine
- Missouri Baptist Medical Center
- Center for Cancer Care and Research
- Mercy Hospital Saint Louis
- Saint Louis-Cape Girardeau CCOP
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Montana Cancer Consortium CCOP
- Northern Rockies Radiation Oncology Center
- Saint Vincent Healthcare
- Frontier Cancer Center and Blood Institute-Billings
- Billings Clinic Cancer Center
- Deaconess Medical Center
- Bozeman Deaconess Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Berdeaux, Donald MD (UIA Investigator)
- Big Sky Oncology
- Great Falls Clinic
- Northern Montana Hospital
- Saint Peter's Community Hospital
- Glacier Oncology PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Hospital
- Montana Cancer Specialists
- Saint Patrick Hospital - Community Hospital
- Guardian Oncology and Center for Wellness
- Nebraska Cancer Research Center
- Missouri Valley Cancer Consortium
- Nebraska Methodist Hospital
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Creighton University Medical Center
- University of Nebraska Medical Center
- Center of Hope at Renown Medical Center
- Renown Regional Medical Center
- Saint Mary's Regional Medical Center
- Exeter Hospital
- Cheshire Medical Center-Dartmouth-Hitchcock Keene
- Dartmouth Hitchcock Medical Center
- Frisbie Hospital
- Ocean Medical Center
- Cooper Hospital University Medical Center
- Hackensack University Medical CCOP
- Hackensack University Medical Center
- Northern New Jersey CCOP
- Monmouth Medical Center
- Morristown Medical Center
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
- Jersey Shore Medical Center
- UMDNJ - New Jersey Medical School
- Riverview Medical Center/Booker Cancer Center
- Overlook Hospital
- Community Medical Center
- Virtua West Jersey Hospital Voorhees
- Southwest Gynecologic Oncology Associates Inc
- University of New Mexico Cancer Center
- Women's Cancer Care Associates LLC
- Island Gynecologic Oncology
- State University of New York Downstate Medical Center
- Roswell Park Cancer Institute
- Queens Hospital Center
- North Shore University Hospital
- Orange Regional Medical Center
- Long Island Jewish Medical Center
- North Shore-LIJ Health System/Center for Advanced Medicine
- Laura and Issac Perlmutter Cancer Center at NYU Langone
- Mount Sinai Medical Center
- Columbia University Medical Center
- Memorial Sloan-Kettering Cancer Center
- Stony Brook University Medical Center
- Saint Joseph's Hospital Health Center
- State University of New York Upstate Medical University
- Good Samaritan Hospital Medical Center
- Randolph Hospital
- Hope Women's Cancer Centers-Asheville
- Cone Health Cancer Center at Alamance Regional
- University of North Carolina at Chapel Hill
- Carolinas Medical Center/Levine Cancer Institute
- Novant Health Presbyterian Medical Center
- Duke University Medical Center
- Wayne Memorial Hospital
- Wayne Radiation Oncology
- Cone Health Cancer Center
- Gynecologic Oncology Network
- Kinston Medical Specialists PA
- FirstHealth of the Carolinas-Moore Regional Hosiptal
- Annie Penn Memorial Hospital
- Rutherford Hospital
- New Hanover Regional Medical Center/Zimmer Cancer Center
- Wilson Medical Center
- Novant Health Oncology Specialists
- Southeast Cancer Consortium-Upstate NCORP
- Wake Forest University Health Sciences
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Altru Cancer Center
- Summa Akron City Hospital/Cooper Cancer Center
- Akron General Medical Center
- Toledo Clinic Cancer Centers-Bowling Green
- Aultman Health Foundation
- University of Cincinnati
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- North Coast Cancer Care-Clyde
- Ohio State University Comprehensive Cancer Center
- Riverside Methodist Hospital
- Mount Carmel Health Center West
- Grandview Hospital
- Good Samaritan Hospital - Dayton
- Samaritan North Health Center
- Dayton CCOP
- Veteran Affairs Medical Center
- Hematology Oncology Center Incorporated
- Blanchard Valley Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Fremont Memorial Hospital
- Wayne Hospital
- Kettering Medical Center
- Lima Memorial Hospital
- Saint Luke's Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Hillcrest Hospital Cancer Center
- Lake University Ireland Cancer Center
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- Firelands Regional Medical Center
- North Coast Cancer Care
- Flower Hospital
- Mercy Hospital of Tiffin
- The Toledo Hospital/Toledo Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- Fulton County Health Center
- Clinton Memorial Hospital
- Greene Memorial Hospital
- University of Oklahoma Health Sciences Center
- Cancer Care Associates-Midtown
- Tulsa Cancer Institute
- Bay Area Hospital
- Legacy Good Samaritan Hospital and Medical Center
- Compass Oncology Rose Quarter
- Kaiser Permanente
- Oregon Health and Science University
- Abington Memorial Hospital
- Lehigh Valley Hospital-Cedar Crest
- Bryn Mawr Hospital
- Ephrata Cancer Center
- Penn State Milton S Hershey Medical Center
- Lancaster General Hospital
- Riddle Memorial Hospital
- Paoli Memorial Hospital
- University of Pennsylvania/Abramson Cancer Center
- Pennsylvania Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Chestnut Hill Health System
- UPMC-Magee Womens Hospital
- West Penn Hospital
- Mercy Hospital
- Hematology and Oncology Associates of North East Pennsylvania
- Scranton Hematology Oncology
- Reading Hospital
- Lankenau Medical Center
- Mainline Health CCOP
- WellSpan Health-York Cancer Center
- WellSpan Health-York Hospital
- Women and Infants Hospital
- AnMed Health Hospital
- Medical University of South Carolina
- Greenville Health System Cancer Institute-Eastside
- Black Hills Obstetrics and Gynecology
- Sanford Cancer Center-Oncology Clinic
- Sanford USD Medical Center - Sioux Falls
- Chattanooga Gynecological Oncology
- Chattanooga's Program in Women's Oncology
- East Tennessee State University
- Knoxville Gynecologic Cancer Specialists PC
- University of Tennesee Health Science Center
- Meharry Medical College
- Vanderbilt University/Ingram Cancer Center
- The Don and Sybil Harrington Cancer Center
- Brooke Army Medical Center
- University of Texas Medical Branch
- M D Anderson Cancer Center
- Texas Tech University Health Sciences Center
- Scott and White Memorial Hospital
- American Fork Hospital
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Cottonwood Hospital Medical Center
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Dixie Medical Center Regional Cancer 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
- Kaiser Permanente - Fair Oaks Medical Center
- Fredericksburg Oncology Inc
- Rappahannock General Hospital
- Bon Secours Mary Immaculate Hospital
- Virginia Oncology Associates - Lake Wright
- Virginia Commonwealth University/Massey Cancer Center
- Carilion Clinic Gynecological Oncology
- MultiCare Auburn Medical Center
- Providence Regional Cancer System-Centralia
- Saint Francis Hospital
- Saint Clare Hospital
- Providence - Saint Peter Hospital
- Capital Medical Center
- MultiCare Good Samaritan Hospital
- Virginia Mason CCOP
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
- University of Washington Medical Center
- MultiCare Allenmore Hospital
- MultiCare Tacoma General Hospital
- Northwest CCOP
- Northwest Medical Specialties PLLC
- Saint Joseph Medical Center
- Multicare Health System
- Madigan Army Medical Center
- Marshfield Clinic-Chippewa Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Sacred Heart Hospital
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Mary's Hospital
- Aurora BayCare Medical Center
- Dean Hematology and Oncology Clinic
- University of Wisconsin Hospital and Clinics
- Holy Family Memorial Hospital
- Bay Area Medical Center
- Marshfield Clinic
- Saint Joseph's Hospital
- Medical Consultants Limited
- Froedtert and the Medical College of Wisconsin
- Marshfield Clinic-Minocqua Center
- Oconomowoc Memorial Hospital-ProHealth Care Inc
- Green Bay Oncology - Oconto Falls
- Marshfield Clinic at James Beck Cancer Center
- Marshfield Clinic-Rice Lake Center
- Vince Lombardi Cancer Clinic-Sheboygan
- Vince Lombardi Cancer Clinic - Slinger
- Saint Michael's Hospital
- Green Bay Oncology - Sturgeon Bay
- Waukesha Memorial Hospital
- Aurora West Allis Medical Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Welch Cancer Center
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
- Tohoku University School of Medicine
- Kure National Hospital
- Iwate Medical University School of Medicine
- Kagoshima City Hospital
- Keio University
- National Hospital Organization-Kobe Medical Center
- Shikoku Cancer Center
- Saitama Medical University International Medical Center
- National Cancer Center Hospital
- Tottori University
- Samsung Medical Center
- Seoul National University Hospital
- Yongdong Severence Hospital
- Asan Medical Center
- Korea Cancer Center Hospital
- Ajou University Hospital
- Kangnam Sacred Heart Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Arm I (placebo, paclitaxel, carboplatin)
Arm II (placebo, paclitaxel, carboplatin, bevacizumab)
Arm III (paclitaxel, carboplatin, bevacizumab)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Beginning in course 2, patients also receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive placebo alone IV over 30-90 minutes on day 1. Treatment with placebo repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity.
Patients receive paclitaxel and carboplatin as in arm I. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive placebo alone IV over 30-90 minutes on day 1. Treatment with placebo repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity.
Patients receive paclitaxel and carboplatin as in arm I. Beginning in course 2, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses. Beginning in course 7, patients receive bevacizumab alone IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity.