Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

July 19, 2019 updated by: National Cancer Institute (NCI)

A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC # 704865) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women With Newly Diagnosed, Previously Untreated, Stage III or IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer

This randomized phase III trial studies carboplatin, paclitaxel, and bevacizumab to see how well they work compared to carboplatin, paclitaxel, and placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To determine if the addition of 5 concurrent cycles of bevacizumab to 6 cycles of standard therapy (carboplatin and paclitaxel) (Arm II) increases the duration of progression-free survival (PFS) when compared to 6 cycles of standard therapy alone (Arm I) in women with newly diagnosed stage III (with any gross residual disease) and stage IV, epithelial ovarian, peritoneal primary or fallopian tube cancer.

II. To determine if the addition of 5 concurrent cycles of bevacizumab plus extended bevacizumab for 16 cycles beyond the 6 cycles of standard therapy (carboplatin and paclitaxel) (Arm III) increases progression-free survival when compared to 6 cycles of standard therapy (Arm I) in women with newly diagnosed stage III (with any gross residual disease) and stage IV, epithelial ovarian, peritoneal primary or fallopian tube cancer.

SECONDARY OBJECTIVES:

I. In the event that both Arm II and Arm III regimens are superior to the Arm I regimen with respect to progression-free survival, to determine whether the Arm III regimen prolongs progression-free survival when compared to the Arm II regimen.

II. To determine whether the Arm II or Arm III regimen increases the duration of overall survival when compared with the Arm I regimen.

III. To compare each of the experimental regimens to the Arm I regimen with respect to the incidence of severe toxicities or serious adverse events.

IV. To determine the impact on Quality of Life (QOL, as measured by the Functional Assessment of Cancer Therapy-Ovarian [FACT-O] trial outcome index [TOI]) following treatment with the above regimens.

TERTIARY OBJECTIVES:

I. To assess the relationship between angiogenic markers and clinical outcome including tumor response, progression-free survival and overall survival in patients randomized to standard cytotoxic chemotherapy (paclitaxel and carboplatin) without bevacizumab, with concurrent bevacizumab or with extended bevacizumab.

II. To assess the predictive value of a set of genes whose expression correlates with survival of patients with stage III (with any gross residual disease) and stage IV, epithelial ovarian, peritoneal primary or fallopian tube cancer.

III. To bank whole blood for research. IV. To determine if genetic variations in genes associated with essential hypertension including WNK lysine deficient protein kinase 1 (WNK1), G protein-coupled receptor kinase 4 (GRK4) and kallikrein B (KLKB1) predict which patients are likely to develop bevacizumab-induced hypertension.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive paclitaxel intravenously (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.

ARM II: 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.

ARM III: 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.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study Type

Interventional

Enrollment (Actual)

1873

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Toronto, Ontario, Canada, M4N 3M5
    - Odette Cancer Centre- Sunnybrook Health Sciences Centre
Japan
- - Kobe, Japan, 654-0155
    - National Hospital Organization-Kobe Medical Center
  - Matsuyama, Japan, 791-0280
    - Shikoku Cancer Center
  - Saitama, Japan, 350-1298
    - Saitama Medical University International Medical Center
  - Tokyo, Japan, 104 0045
    - National Cancer Center Hospital
  - Tottori, Japan, 680-8550
    - Tottori University
- Aoba-ku
  - Sendai, Aoba-ku, Japan, 980-8574
    - Tohoku University School of Medicine
- Hiroshima
  - Kure, Hiroshima, Japan, 737
    - Kure National Hospital
- Iwate
  - Morioka, Iwate, Japan, 020-8505
    - Iwate Medical University School of Medicine
- Kagoshima
  - Kagoshima City, Kagoshima, Japan, 890-8760
    - Kagoshima City Hospital
- Tokyo
  - Shinjuku-ku, Tokyo, Japan, 160-8582
    - Keio University
Korea, Republic of
- - Seoul, Korea, Republic of, 138-736
    - Asan Medical Center
  - Seoul, Korea, Republic of, 110-744
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 139-706
    - Korea Cancer Center Hospital
  - Seoul, Korea, Republic of, 135-720
    - Yongdong Severence Hospital
  - Suwon, Korea, Republic of, 443-721
    - Ajou University Hospital
  - Youngdungpo-gu, Korea, Republic of, 150-071
    - KangNam Sacred Heart Hospital
- Korea
  - Seoul, Korea, Korea, Republic of, 135-710
    - Samsung Medical Center
United States
- Alabama
  - Anniston, Alabama, United States, 36202
    - Northeast Alabama Regional Medical Center
  - Birmingham, Alabama, United States, 35233
    - University of Alabama at Birmingham Cancer Center
  - Huntsville, Alabama, United States, 35805
    - Clearview Cancer Institute
  - Mobile, Alabama, United States, 36607
    - Mobile Infirmary Medical Center
- Arizona
  - Glendale, Arizona, United States, 85306
    - Banner Thunderbird Medical Center
  - Mesa, Arizona, United States, 85202
    - Banner Desert Medical Center
  - Mesa, Arizona, United States, 85206
    - Banner Baywood Medical Center
  - Phoenix, Arizona, United States, 85006
    - Banner Good Samaritan Medical Center
  - Phoenix, Arizona, United States, 85006
    - Western Regional CCOP
  - Scottsdale, Arizona, United States, 85259
    - Mayo Clinic in Arizona
- Arkansas
  - Fayetteville, Arkansas, United States, 72703
    - Highlands Oncology Group PA - Fayetteville
  - Fayetteville, Arkansas, United States, 72703
    - Washington Regional Medical Center - Fayetteville
  - Fort Smith, Arkansas, United States, 72903
    - Mercy Hospital Fort Smith
  - Little Rock, Arkansas, United States, 72205
    - University of Arkansas for Medical Sciences
- California
  - Burbank, California, United States, 91505
    - Providence Saint Joseph Medical Center/Disney Family Cancer Center
  - Castro Valley, California, United States, 94546
    - Eden Hospital Medical Center
  - Castro Valley, California, United States, 94546
    - East Bay Radiation Oncology Center
  - Castro Valley, California, United States, 94546
    - Valley Medical Oncology Consultants-Castro Valley
  - Concord, California, United States, 94520
    - John Muir Medical Center-Concord Campus
  - Emeryville, California, United States, 94608
    - Bay Area Breast Surgeons Inc
  - Fairfield, California, United States, 94533
    - Northbay Cancer Center
  - Fremont, California, United States, 94538
    - Kaiser Permanente-Fremont
  - Fremont, California, United States, 94538
    - Valley Medical Oncology Consultants-Fremont
  - Fresno, California, United States, 93720
    - Cancer Care Associates of Fresno Medical Group Inc
  - Fullerton, California, United States, 92835
    - Saint Jude Medical Center
  - Loma Linda, California, United States, 92354
    - Loma Linda University Medical Center
  - Long Beach, California, United States, 90806
    - Long Beach Memorial Medical Center-Todd Cancer Institute
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Medical Center
  - Los Angeles, California, United States, 90095
    - UCLA / Jonsson Comprehensive Cancer Center
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Los Angeles Medical Center
  - Martinez, California, United States, 94553-3156
    - Contra Costa Regional Medical Center
  - Mountain View, California, United States, 94040
    - El Camino Hospital
  - Oakland, California, United States, 94611
    - Kaiser Permanente-Oakland
  - Oakland, California, United States, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, United States, 94609
    - Hematology and Oncology Associates-Oakland
  - Oakland, California, United States, 94602
    - Highland General Hospital
  - Oakland, California, United States, 94609
    - Tom K Lee Inc
  - Oakland, California, United States, 94609
    - Bay Area Tumor Institute
  - Orange, California, United States, 92868
    - UC Irvine Health/Chao Family Comprehensive Cancer Center
  - Palo Alto, California, United States, 94304
    - Stanford Cancer Institute
  - Pleasanton, California, United States, 94588
    - Valley Care Health System - Pleasanton
  - Pleasanton, California, United States, 94588
    - Valley Medical Oncology Consultants
  - Redwood City, California, United States, 94063
    - Kaiser Permanente-Redwood City
  - Richmond, California, United States, 94801
    - Kaiser Permanente-Richmond
  - Roseville, California, United States, 95661
    - Kaiser Permanente-Roseville
  - Sacramento, California, United States, 95817
    - University of California Davis Comprehensive Cancer Center
  - Sacramento, California, United States, 95823
    - Kaiser Permanente-South Sacramento
  - Sacramento, California, United States, 95825
    - Kaiser Permanente - Sacramento
  - San Diego, California, United States, 92108
    - Kaiser Permanente-San Diego Mission
  - San Francisco, California, United States, 94115
    - Kaiser Permanente-San Francisco
  - San Francisco, California, United States, 94115
    - UCSF Medical Center-Mount Zion
  - San Jose, California, United States, 95119
    - Kaiser Permanente-Santa Teresa-San Jose
  - San Leandro, California, United States, 94577
    - Kaiser Permanente San Leandro
  - San Pablo, California, United States, 94806
    - Doctors Medical Center- JC Robinson Regional Cancer Center
  - San Rafael, California, United States, 94903
    - Kaiser Permanente-San Rafael
  - Santa Barbara, California, United States, 93105
    - Cancer Center of Santa Barbara
  - Santa Barbara, California, United States, 93105
    - Santa Barbara Hematology Oncology Group Inc-Santa Barbara
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara
  - Santa Rosa, California, United States, 95403
    - Kaiser Permanente-Santa Rosa
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente-South San Francisco
  - Stockton, California, United States, 95210
    - Kaiser Permanente-Stockton
  - Vallejo, California, United States, 94589
    - Kaiser Permanente-Vallejo
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente-Walnut Creek
  - Walnut Creek, California, United States, 94598
    - John Muir Medical Center-Walnut Creek
- Colorado
  - Aurora, Colorado, United States, 80012
    - The Medical Center of Aurora
  - Aurora, Colorado, United States, 80010
    - Colorado Gynecologic Oncology Group
  - Boulder, Colorado, United States, 80301
    - Boulder Community Hospital
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80909
    - Memorial Hospital Colorado Springs
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80218
    - Presbyterian - Saint Lukes Medical Center - Health One
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Exempla Saint Joseph Hospital
  - Denver, Colorado, United States, 80224-2522
    - Colorado Cancer Research Program CCOP
  - Englewood, Colorado, United States, 80113
    - Swedish Medical Center
  - Englewood, Colorado, United States, 80110
    - Rocky Mountain Gynecologic Oncology PC
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80528
    - Front Range Cancer Specialists
  - Grand Junction, Colorado, United States, 81502
    - Saint Mary's Hospital and Regional Medical Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Thornton, Colorado, United States, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Hartford, Connecticut, United States, 06102
    - Hartford Hospital
  - Hartford, Connecticut, United States, 06105
    - Saint Francis Hospital and Medical Center
  - Manchester, Connecticut, United States, 06040
    - Manchester Memorial Hospital
  - New Britain, Connecticut, United States, 06050
    - The Hospital of Central Connecticut
  - New Haven, Connecticut, United States, 06520
    - Yale University
  - Norwalk, Connecticut, United States, 06856
    - Norwalk Hospital
  - Stamford, Connecticut, United States, 06904
    - Stamford Hospital/Bennett Cancer Center
- Delaware
  - Lewes, Delaware, United States, 19958
    - Beebe Medical Center
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
  - Newark, Delaware, United States, 19713
    - Christiana Gynecologic Oncology LLC
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - Washington Hospital Center
- Florida
  - Clearwater, Florida, United States, 33756
    - Morton Plant Hospital
  - Fort Lauderdale, Florida, United States, 33308
    - Holy Cross Hospital
  - Fort Myers, Florida, United States, 33901
    - Lee Memorial Health System
  - Fort Myers, Florida, United States, 33905
    - Florida Gynecologic Oncology
  - Jacksonville, Florida, United States, 32224-9980
    - Mayo Clinic in Florida
  - Jacksonville, Florida, United States, 32204
    - Saint Vincent's Medical Center
  - Jupiter, Florida, United States, 33458
    - Jupiter Medical Center
  - Miami, Florida, United States, 33136
    - University of Miami Miller School of Medicine-Sylvester Cancer Center
  - Miami Beach, Florida, United States, 33140
    - Mount Sinai Medical Center
  - Orlando, Florida, United States, 32803
    - Florida Hospital Orlando
  - Orlando, Florida, United States, 32806
    - UF Cancer Center at Orlando Health
  - Saint Petersburg, Florida, United States, 33701
    - Bayfront Outpatient Health Clinic
  - Sarasota, Florida, United States, 34239
    - Sarasota Memorial Hospital
  - West Palm Beach, Florida, United States, 33401
    - Florida Cancer Specialists-West Palm Beach
- Georgia
  - Albany, Georgia, United States, 31701
    - Phoebe Putney Memorial Hospital
  - Atlanta, Georgia, United States, 30303
    - Grady Health System
  - Atlanta, Georgia, United States, 30322
    - Emory University/Winship Cancer Institute
  - Augusta, Georgia, United States, 30912
    - Georgia Regents University Medical Center
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Medical Center
  - Macon, Georgia, United States, 31201
    - Central Georgia Gynecologic Oncology
  - Savannah, Georgia, United States, 31404
    - Memorial University Medical Center
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96817
    - The Cancer Center of Hawaii-Liliha
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96859
    - Tripler Army Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Oncare Hawaii Inc-POB II
  - Honolulu, Hawaii, United States, 96817
    - Oncare Hawaii Inc-Kuakini
  - Wailuku, Hawaii, United States, 96793
    - Maui Memorial Medical Center
  - Wailuku, Hawaii, United States, 96793
    - Pacific Cancer Institute of Maui
- Idaho
  - Boise, Idaho, United States, 83712
    - Saint Luke's Mountain States Tumor Institute
- Illinois
  - Alton, Illinois, United States, 62002
    - Saint Anthony's Health
  - Arlington Heights, Illinois, United States, 60005
    - Northwest Community Hospital
  - Aurora, Illinois, United States, 60504
    - Rush - Copley Medical Center
  - Bloomington, Illinois, United States, 61701
    - Saint Joseph Medical Center
  - Canton, Illinois, United States, 61520
    - Graham Hospital Association
  - Carthage, Illinois, United States, 62321
    - Memorial Hospital
  - Chicago, Illinois, United States, 60611
    - Northwestern University
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
  - Chicago, Illinois, United States, 60637
    - University of Chicago Comprehensive Cancer Center
  - Chicago, Illinois, United States, 60612
    - University of Illinois
  - Chicago, Illinois, United States, 60608
    - Mount Sinai Hospital Medical Center
  - Chicago, Illinois, United States, 60625
    - Swedish Covenant Hospital
  - Chicago, Illinois, United States, 60631
    - Presence Resurrection Medical Center
  - Chicago, Illinois, United States, 60640
    - Weiss Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Elmhurst, Illinois, United States, 60126
    - Elmhurst Memorial Hospital
  - Eureka, Illinois, United States, 61530
    - Eureka Hospital
  - Evanston, Illinois, United States, 60201
    - NorthShore University HealthSystem-Evanston Hospital
  - Evanston, Illinois, United States, 60202
    - Saint Francis Hospital
  - Galesburg, Illinois, United States, 61401
    - Galesburg Cottage Hospital
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare Galesburg
  - Harvey, Illinois, United States, 60426
    - Ingalls Memorial Hospital
  - Havana, Illinois, United States, 62644
    - Mason District Hospital
  - Hopedale, Illinois, United States, 61747
    - Hopedale Medical Complex - Hospital
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associates Limited
  - Kewanee, Illinois, United States, 61443
    - Kewanee Hospital
  - Macomb, Illinois, United States, 61455
    - Mcdonough District Hospital
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center
  - Moline, Illinois, United States, 61265
    - Garneau, Stewart C MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Porubcin, Michael MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Sharis, Christine M MD (UIA Investigator)
  - Moline, Illinois, United States, 61265
    - Stoffel, Thomas J MD (UIA Investigator)
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Normal, Illinois, United States, 61761
    - Community Cancer Center Foundation
  - Normal, Illinois, United States, 61761
    - Bromenn Regional Medical Center
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Ottawa, Illinois, United States, 61350
    - Ottawa Regional Hospital and Healthcare Center
  - Palatine, Illinois, United States, 60067
    - Chicago Gynecologic Oncology SC
  - Park Ridge, Illinois, United States, 60068
    - Advocate Lutheran General Hospital
  - Pekin, Illinois, United States, 61554
    - Pekin Cancer Treatment Center
  - Pekin, Illinois, United States, 61554
    - Pekin Hospital
  - Peoria, Illinois, United States, 61637
    - OSF Saint Francis Medical Center
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peoria, Illinois, United States, 61614
    - Proctor Hospital
  - Peoria, Illinois, United States, 61603
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61615
    - Illinois Oncology Research Association CCOP
  - Peru, Illinois, United States, 61354
    - Illinois Valley Hospital
  - Princeton, Illinois, United States, 61356
    - Perry Memorial Hospital
  - Rockford, Illinois, United States, 61108
    - Saint Anthony Medical Center
  - Spring Valley, Illinois, United States, 61362
    - Saint Margaret's Hospital
  - Springfield, Illinois, United States, 62781
    - Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Urbana, Illinois, United States, 61801
    - Carle Clinic-Urbana Main
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - Franciscan St. Francis Health-Beech Grove
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Fort Wayne, Indiana, United States, 46845
    - Fort Wayne Medical Oncology and Hematology Inc-Parkview
  - Indianapolis, Indiana, United States, 46202
    - Indiana University/Melvin and Bren Simon Cancer Center
  - Indianapolis, Indiana, United States, 46260
    - Saint Vincent Hospital and Health Services
  - Kokomo, Indiana, United States, 46904
    - Community Howard Regional Health
  - La Porte, Indiana, United States, 46350
    - IU Health La Porte Hospital
  - Michigan City, Indiana, United States, 46360
    - Franciscan Saint Anthony Health-Michigan City
  - Mishawaka, Indiana, United States, 46545
    - Saint Joseph Regional Medical Center-Mishawaka
  - Munster, Indiana, United States, 46321
    - The Community Hospital
  - Richmond, Indiana, United States, 47374
    - Reid Hospital and Health Care Services
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46617
    - South Bend Clinic
  - South Bend, Indiana, United States, 46628
    - Northern Indiana Cancer Research Consortium CCOP
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic PC-William R Bliss Cancer Center
  - Bettendorf, Iowa, United States, 52722
    - Constantinou, Costas L MD (UIA Investigator)
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Oncology Associates at Mercy Medical Center
  - Cedar Rapids, Iowa, United States, 52403
    - Cedar Rapids Oncology Association
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates-West Des Moines
  - Davenport, Iowa, United States, 52803
    - Genesis Medical Center - East Campus
  - Davenport, Iowa, United States, 52804
    - Genesis Medical Center - West Campus
  - Des Moines, Iowa, United States, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates-Des Moines
  - Des Moines, Iowa, United States, 50316
    - Iowa Lutheran Hospital
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates-Laurel
  - Des Moines, Iowa, United States, 50307
    - Mercy Capitol
  - Des Moines, Iowa, United States, 50309
    - Iowa Oncology Research Association CCOP
  - Iowa City, Iowa, United States, 52242
    - University of Iowa/Holden Comprehensive Cancer Center
  - Sioux City, Iowa, United States, 51101
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, United States, 51104
    - Saint Luke's Regional Medical Center
  - Sioux City, Iowa, United States, 51101-1733
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, United States, 51104
    - Mercy Medical Center-Sioux City
  - Waterloo, Iowa, United States, 50702
    - Covenant Medical Center
  - Waterloo, Iowa, United States, 50701
    - Cedar Valley Medical Specialists
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas - El Dorado
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kansas City, Kansas, United States, 66160
    - University of Kansas Cancer Center
  - Kansas City, Kansas, United States, 66112
    - Providence Medical Center
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas-Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas - Newton
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, United States, 66210
    - Radiation Oncology Practice Corporation Southwest
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas - Parsons
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas - Salina
  - Shawnee Mission, Kansas, United States, 66204
    - Shawnee Mission Medical Center-KCCC
  - Topeka, Kansas, United States, 66606
    - Saint Francis Hospital and Medical Center - Topeka
  - Topeka, Kansas, United States, 66604
    - Stormont-Vail Regional Health Center
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67208
    - Associates In Womens Health
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Main Office
  - Wichita, Kansas, United States, 67214
    - Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67214
    - Wichita CCOP
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas - Winfield
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky/Markey Cancer Center
  - Louisville, Kentucky, United States, 40202
    - Norton Hospital Pavilion and Medical Campus
  - Louisville, Kentucky, United States, 40202
    - The James Graham Brown Cancer Center at University of Louisville
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - Tulane University Health Sciences Center
  - Shreveport, Louisiana, United States, 71101
    - Christus Schumpert Saint Mary's Place
- Maine
  - Bangor, Maine, United States, 04401
    - Eastern Maine Medical Center
  - Portland, Maine, United States, 04102
    - Maine Medical Center-Bramhall Campus
- Maryland
  - Baltimore, Maryland, United States, 21237
    - MedStar Franklin Square Medical Center/Weinberg Cancer Institute
  - Baltimore, Maryland, United States, 21287
    - Johns Hopkins University/Sidney Kimmel Cancer Center
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center
  - Easton, Maryland, United States, 21601
    - The Memorial Hospital at Easton
  - Easton, Maryland, United States, 21601
    - Memorial Hospital at Easton - Shore Regional Cancer Center
  - Elkton, Maryland, United States, 21921
    - Union Hospital of Cecil County
  - Kensington, Maryland, United States, 20895
    - Associates in Oncology Hematology PC -Kensington
  - Largo, Maryland, United States, 20774
    - Kaiser Permanente - Largo Medical Center
  - Lutherville, Maryland, United States, 21093
    - Kaiser Permanente - Towson Medical Center
  - Rockville, Maryland, United States, 20850
    - Kaiser Permanente - Shady Grove Medical Center
  - Rockville, Maryland, United States, 20850
    - Maryland Oncology Hematology PA-Aquilino Cancer Center
  - Silver Spring, Maryland, United States, 20910
    - Holy Cross Hospital
- Massachusetts
  - Pittsfield, Massachusetts, United States, 01201
    - Berkshire Hematology Oncology PC
  - Springfield, Massachusetts, United States, 01199
    - Baystate Medical Center
  - Worcester, Massachusetts, United States, 01655
    - University of Massachusetts Medical School
  - Worcester, Massachusetts, United States, 01605
    - Commonwealth Hematology Oncology PC-Worcester
- Michigan
  - Adrian, Michigan, United States, 49221
    - Bixby Medical Center
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Hospital
  - Ann Arbor, Michigan, United States, 48106
    - Michigan Cancer Research Consortium CCOP
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Comprehensive Cancer Center
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Big Rapids, Michigan, United States, 49307
    - Spectrum Health Big Rapids Hospital
  - Dearborn, Michigan, United States, 48124
    - Oakwood Hospital and Medical Center
  - Detroit, Michigan, United States, 48236
    - Saint John Hospital and Medical Center
  - Detroit, Michigan, United States, 48201
    - Wayne State University/Karmanos Cancer Institute
  - Escanaba, Michigan, United States, 49431
    - Green Bay Oncology - Escanaba
  - Flint, Michigan, United States, 48502
    - Hurley Medical Center
  - Flint, Michigan, United States, 48532
    - Genesys Regional Medical Center-West Flint Campus
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health at Butterworth Campus
  - Grand Rapids, Michigan, United States, 49503
    - Mercy Health Saint Mary's
  - Grand Rapids, Michigan, United States, 49503
    - Grand Rapids Clinical Oncology Program
  - Grand Rapids, Michigan, United States, 49506
    - Spectrum Health-Blodgett Campus
  - Grand Rapids, Michigan, United States, 49546
    - Gynecologic Oncology of West Michigan PLLC
  - Holland, Michigan, United States, 49423
    - Holland Community Hospital
  - Iron Mountain, Michigan, United States, 49801
    - Green Bay Oncology - Iron Mountain
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Saint Mary Mercy Hospital
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital
  - Monroe, Michigan, United States, 48162
    - Toledo Clinic Cancer Centers-Monroe
  - Muskegon, Michigan, United States, 49444
    - Mercy Health Mercy Campus
  - Muskegon, Michigan, United States, 49442
    - Mercy Health Partners-Hackley Campus
  - Petoskey, Michigan, United States, 49770
    - McLaren-Northern Michigan
  - Pontiac, Michigan, United States, 48341
    - Saint Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Saint Joseph Mercy Port Huron
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital-Royal Oak
  - Saginaw, Michigan, United States, 48601
    - Saint Mary's of Michigan
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Hospital
  - Southfield, Michigan, United States, 48075
    - Providence Hospital-Southfield Cancer Center
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
  - Wyoming, Michigan, United States, 49519
    - Metro Health Hospital
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Cancer Center
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Saint Mary's Medical Center
  - Duluth, Minnesota, United States, 55805
    - Miller-Dwan Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview-Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55455
    - University of Minnesota Medical Center-Fairview
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Robbinsdale, Minnesota, United States, 55422
    - Hubert H Humphrey Cancer Center
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro-Minnesota NCI Community Oncology Research Program
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology and Hematology PA-Woodbury
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - Saint Dominic-Jackson Memorial Hospital
  - Pascagoula, Mississippi, United States, 39581
    - Singing River Hospital
- Missouri
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63701
    - Southeast Missouri Hospital
  - Columbia, Missouri, United States, 65212
    - University of Missouri - Ellis Fischel
  - Independence, Missouri, United States, 64057
    - Centerpoint Medical Center LLC
  - Jefferson City, Missouri, United States, 65101
    - Capital Regional Medical Center
  - Kansas City, Missouri, United States, 64116
    - North Kansas City Hospital
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Hospital of Kansas City
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Kansas City, Missouri, United States, 64108
    - Truman Medical Center
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Cancer Institute
  - Kansas City, Missouri, United States, 64114
    - Saint Joseph Health Center
  - Kansas City, Missouri, United States, 64114
    - Radiation Oncology Practice Corporation South
  - Kansas City, Missouri, United States, 64154
    - Radiation Oncology Practice Corporation - North
  - Liberty, Missouri, United States, 64068
    - Liberty Radiation Oncology Center
  - Liberty, Missouri, United States, 64068
    - Liberty Hospital
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - Saint Louis, Missouri, United States, 63110
    - Saint Louis University Hospital
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - Saint Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - Saint Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Saint Louis, Missouri, United States, 63141
    - Saint Louis-Cape Girardeau CCOP
  - Saint Louis, Missouri, United States, 63141
    - Center for Cancer Care and Research
  - Springfield, Missouri, United States, 65804
    - Cancer Research for the Ozarks NCORP
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
- Montana
  - Billings, Montana, United States, 59101
    - Saint Vincent Healthcare
  - Billings, Montana, United States, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, United States, 59101
    - Montana Cancer Consortium CCOP
  - Billings, Montana, United States, 59102
    - Frontier Cancer Center and Blood Institute-Billings
  - Billings, Montana, United States, 59107
    - Billings Clinic Cancer Center
  - Billings, Montana, United States, 59107
    - Deaconess Medical Center
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare- Sletten Cancer Institute
  - Great Falls, Montana, United States, 59405
    - Berdeaux, Donald MD (UIA Investigator)
  - Great Falls, Montana, United States, 59405
    - Big Sky Oncology
  - Havre, Montana, United States, 59501
    - Northern Montana Hospital
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, United States, 59901
    - Glacier Oncology PLLC
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula, Montana, United States, 59804
    - Guardian Oncology and Center for Wellness
  - Missoula, Montana, United States, 59801
    - Community Medical Hospital
  - Missoula, Montana, United States, 59802
    - Montana Cancer Specialists
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Nebraska Cancer Research Center
  - Omaha, Nebraska, United States, 68114
    - Nebraska Methodist Hospital
  - Omaha, Nebraska, United States, 68198
    - University of Nebraska Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, United States, 68131
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68106
    - Missouri Valley Cancer Consortium
- Nevada
  - Reno, Nevada, United States, 89502
    - Renown Regional Medical Center
  - Reno, Nevada, United States, 89503
    - Saint Mary's Regional Medical Center
  - Reno, Nevada, United States, 89502
    - Center of Hope at Renown Medical Center
- New Hampshire
  - Exeter, New Hampshire, United States, 03833
    - Exeter Hospital
  - Keene, New Hampshire, United States, 03431
    - Cheshire Medical Center-Dartmouth-Hitchcock Keene
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Medical Center
  - Rochester, New Hampshire, United States, 03867
    - Frisbie Hospital
- New Jersey
  - Brick, New Jersey, United States, 08724
    - Ocean Medical Center
  - Camden, New Jersey, United States, 08103
    - Cooper Hospital University Medical Center
  - Hackensack, New Jersey, United States, 07601
    - Hackensack University Medical Center
  - Hackensack, New Jersey, United States, 07601
    - Hackensack University Medical CCOP
  - Hackensack, New Jersey, United States, 07601
    - Northern New Jersey CCOP
  - Long Branch, New Jersey, United States, 07740
    - Monmouth Medical Center
  - Morristown, New Jersey, United States, 07960
    - Morristown Medical Center
  - Mount Holly, New Jersey, United States, 08060
    - Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
  - Neptune, New Jersey, United States, 07753
    - Jersey Shore Medical Center
  - Newark, New Jersey, United States, 07103
    - UMDNJ - New Jersey Medical School
  - Red Bank, New Jersey, United States, 07701
    - Riverview Medical Center/Booker Cancer Center
  - Summit, New Jersey, United States, 07902
    - Overlook Hospital
  - Toms River, New Jersey, United States, 08755
    - Community Medical Center
  - Voorhees, New Jersey, United States, 08043
    - Virtua West Jersey Hospital Voorhees
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - Southwest Gynecologic Oncology Associates Inc
  - Albuquerque, New Mexico, United States, 87106
    - University of New Mexico Cancer Center
- New York
  - Albany, New York, United States, 12208
    - Women's Cancer Care Associates LLC
  - Brightwaters, New York, United States, 11718
    - Island Gynecologic Oncology
  - Brooklyn, New York, United States, 11203
    - State University of New York Downstate Medical Center
  - Buffalo, New York, United States, 14263
    - Roswell Park Cancer Institute
  - Jamaica, New York, United States, 11432
    - Queens Hospital Center
  - Manhasset, New York, United States, 11030
    - North Shore University Hospital
  - Middletown, New York, United States, 10940
    - Orange Regional Medical Center
  - New Hyde Park, New York, United States, 11040
    - Long Island Jewish Medical Center
  - New Hyde Park, New York, United States, 11040
    - North Shore-LIJ Health System/Center for Advanced Medicine
  - New York, New York, United States, 10032
    - Columbia University Medical Center
  - New York, New York, United States, 10065
    - Memorial Sloan-Kettering Cancer Center
  - New York, New York, United States, 10029
    - Mount Sinai Medical Center
  - New York, New York, United States, 10016
    - Laura and Issac Perlmutter Cancer Center at NYU Langone
  - Stony Brook, New York, United States, 11794
    - Stony Brook University Medical Center
  - Syracuse, New York, United States, 13210
    - State University of New York Upstate Medical University
  - Syracuse, New York, United States, 13203
    - Saint Joseph's Hospital Health Center
  - West Islip, New York, United States, 11795
    - Good Samaritan Hospital Medical Center
- North Carolina
  - Asheboro, North Carolina, United States, 27203
    - Randolph Hospital
  - Asheville, North Carolina, United States, 28816
    - Hope Women's Cancer Centers-Asheville
  - Burlington, North Carolina, United States, 27216
    - Cone Health Cancer Center at Alamance Regional
  - Chapel Hill, North Carolina, United States, 27599
    - University of North Carolina at Chapel Hill
  - Charlotte, North Carolina, United States, 28203
    - Carolinas Medical Center/Levine Cancer Institute
  - Charlotte, North Carolina, United States, 28204
    - Novant Health Presbyterian Medical Center
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Radiation Oncology
  - Greensboro, North Carolina, United States, 27403
    - Cone Health Cancer Center
  - Greenville, North Carolina, United States, 27834
    - Gynecologic Oncology Network
  - Kinston, North Carolina, United States, 28501
    - Kinston Medical Specialists PA
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth of the Carolinas-Moore Regional Hosiptal
  - Reidsville, North Carolina, United States, 27320
    - Annie Penn Memorial Hospital
  - Rutherfordton, North Carolina, United States, 28139
    - Rutherford Hospital
  - Wilmington, North Carolina, United States, 28401
    - New Hanover Regional Medical Center/Zimmer Cancer Center
  - Wilson, North Carolina, United States, 27893
    - Wilson Medical Center
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
  - Winston-Salem, North Carolina, United States, 27103
    - Novant Health Oncology Specialists
  - Winston-Salem, North Carolina, United States, 27104
    - Southeast Cancer Consortium-Upstate NCORP
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Bismarck, North Dakota, United States, 58501
    - Mid Dakota Clinic
  - Bismarck, North Dakota, United States, 58501
    - Saint Alexius Medical Center
  - Grand Forks, North Dakota, United States, 58201
    - Altru Cancer Center
- Ohio
  - Akron, Ohio, United States, 44304
    - Summa Akron City Hospital/Cooper Cancer Center
  - Akron, Ohio, United States, 44307
    - Akron General Medical Center
  - Bowling Green, Ohio, United States, 43402
    - Toledo Clinic Cancer Centers-Bowling Green
  - Canton, Ohio, United States, 44710
    - Aultman Health Foundation
  - Cincinnati, Ohio, United States, 45267
    - University of Cincinnati
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Foundation
  - Cleveland, Ohio, United States, 44111
    - Cleveland Clinic Cancer Center/Fairview Hospital
  - Clyde, Ohio, United States, 43410
    - North Coast Cancer Care-Clyde
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43210
    - Ohio State University Comprehensive Cancer Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital - Dayton
  - Dayton, Ohio, United States, 45415
    - Samaritan North Health Center
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45420
    - Dayton CCOP
  - Dayton, Ohio, United States, 45428
    - Veteran Affairs Medical Center
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center Incorporated
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Franklin, Ohio, United States, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Fremont, Ohio, United States, 43420
    - Fremont Memorial Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Maumee, Ohio, United States, 43537
    - Toledo Clinic Cancer Centers-Maumee
  - Maumee, Ohio, United States, 43537
    - Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
  - Maumee, Ohio, United States, 43537
    - Saint Luke's Hospital
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Hospital Cancer Center
  - Mentor, Ohio, United States, 44060
    - Lake University Ireland Cancer Center
  - Oregon, Ohio, United States, 43616
    - Saint Charles Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic Cancer Centers-Oregon
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care
  - Sandusky, Ohio, United States, 44870
    - Firelands Regional Medical Center
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - Saint Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic Cancer Centers-Toledo
  - Toledo, Ohio, United States, 43614
    - University of Toledo
  - Toledo, Ohio, United States, 43617
    - Toledo Community Hospital Oncology Program CCOP
  - Toledo, Ohio, United States, 43606
    - The Toledo Hospital/Toledo Children's Hospital
  - Toledo, Ohio, United States, 43623
    - Mercy Saint Anne Hospital
  - Troy, Ohio, United States, 45373
    - Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Wilmington, Ohio, United States, 45177
    - Clinton Memorial Hospital
  - Xenia, Ohio, United States, 45385
    - Greene Memorial Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Tulsa, Oklahoma, United States, 74146
    - Tulsa Cancer Institute
  - Tulsa, Oklahoma, United States, 74104
    - Cancer Care Associates-Midtown
- Oregon
  - Coos Bay, Oregon, United States, 97420
    - Bay Area Hospital
  - Portland, Oregon, United States, 97239
    - Oregon Health and Science University
  - Portland, Oregon, United States, 97210
    - Legacy Good Samaritan Hospital and Medical Center
  - Portland, Oregon, United States, 97227
    - Kaiser Permanente
  - Portland, Oregon, United States, 97227
    - Compass Oncology Rose Quarter
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Abington Memorial Hospital
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Bryn Mawr Hospital
  - Ephrata, Pennsylvania, United States, 17522
    - Ephrata Cancer Center
  - Hershey, Pennsylvania, United States, 17033-0850
    - Penn State Milton S Hershey Medical Center
  - Lancaster, Pennsylvania, United States, 17604
    - Lancaster General Hospital
  - Media, Pennsylvania, United States, 19063
    - Riddle Memorial Hospital
  - Paoli, Pennsylvania, United States, 19301
    - Paoli Memorial Hospital
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19107
    - Thomas Jefferson University Hospital
  - Philadelphia, Pennsylvania, United States, 19104
    - University of Pennsylvania/Abramson Cancer Center
  - Philadelphia, Pennsylvania, United States, 19107
    - Pennsylvania Hospital
  - Philadelphia, Pennsylvania, United States, 19118
    - Chestnut Hill Health System
  - Pittsburgh, Pennsylvania, United States, 15224
    - West Penn Hospital
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC-Magee Womens Hospital
  - Scranton, Pennsylvania, United States, 18510
    - Scranton Hematology Oncology
  - Scranton, Pennsylvania, United States, 18501
    - Mercy Hospital
  - Scranton, Pennsylvania, United States, 18508
    - Hematology and Oncology Associates of North East Pennsylvania
  - West Reading, Pennsylvania, United States, 19611
    - Reading Hospital
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Medical Center
  - Wynnewood, Pennsylvania, United States, 19096
    - Mainline Health CCOP
  - York, Pennsylvania, United States, 17403
    - WellSpan Health-York Cancer Center
  - York, Pennsylvania, United States, 17405
    - WellSpan Health-York Hospital
- Rhode Island
  - Providence, Rhode Island, United States, 02905
    - Women and Infants Hospital
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Hospital
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Greenville, South Carolina, United States, 29615
    - Greenville Health System Cancer Institute-Eastside
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Black Hills Obstetrics and Gynecology
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center-Oncology Clinic
- Tennessee
  - Chattanooga, Tennessee, United States, 37403
    - Chattanooga's Program in Women's Oncology
  - Chattanooga, Tennessee, United States, 37403
    - Chattanooga Gynecological Oncology
  - Johnson City, Tennessee, United States, 37614-0054
    - East Tennessee State University
  - Knoxville, Tennessee, United States, 37920
    - Knoxville Gynecologic Cancer Specialists PC
  - Memphis, Tennessee, United States, 38103
    - University of Tennesee Health Science Center
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University/Ingram Cancer Center
  - Nashville, Tennessee, United States, 37208
    - Meharry Medical College
- Texas
  - Amarillo, Texas, United States, 79106
    - The Don and Sybil Harrington Cancer Center
  - Fort Sam Houston, Texas, United States, 78234
    - Brooke Army Medical Center
  - Galveston, Texas, United States, 77555-0565
    - University of Texas Medical Branch
  - Houston, Texas, United States, 77030
    - M D Anderson Cancer Center
  - Lubbock, Texas, United States, 79430
    - Texas Tech University Health Sciences Center
  - Temple, Texas, United States, 76508
    - Scott and White Memorial Hospital
- Utah
  - American Fork, Utah, United States, 84003
    - American Fork Hospital
  - Cedar City, Utah, United States, 84720
    - Sandra L Maxwell Cancer Center
  - Logan, Utah, United States, 84321
    - Logan Regional Hospital
  - Murray, Utah, United States, 84107
    - Cottonwood Hospital Medical Center
  - Murray, Utah, United States, 84157
    - Intermountain Medical Center
  - Ogden, Utah, United States, 84403
    - McKay-Dee Hospital Center
  - Provo, Utah, United States, 84604
    - Utah Valley Regional Medical Center
  - Saint George, Utah, United States, 84770
    - Dixie Medical Center Regional Cancer Center
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute/University of Utah
  - Salt Lake City, Utah, United States, 84106
    - Utah Cancer Specialists-Salt Lake City
  - Salt Lake City, Utah, United States, 84143
    - LDS Hospital
  - Salt Lake City, Utah, United States, 84103
    - Intermountain Health Care
- Vermont
  - Burlington, Vermont, United States, 05401
    - University of Vermont Medical Center
- Virginia
  - Annandale, Virginia, United States, 22003
    - Northern Virginia Pelvic Surgery Associates
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia Cancer Center
  - Danville, Virginia, United States, 24541
    - Danville Regional Medical Center
  - Fairfax, Virginia, United States, 22033
    - Kaiser Permanente - Fair Oaks Medical Center
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology Inc
  - Kilmarnock, Virginia, United States, 22482
    - Rappahannock General Hospital
  - Newport News, Virginia, United States, 23602
    - Bon Secours Mary Immaculate Hospital
  - Norfolk, Virginia, United States, 23502
    - Virginia Oncology Associates - Lake Wright
  - Richmond, Virginia, United States, 23298
    - Virginia Commonwealth University/Massey Cancer Center
  - Roanoke, Virginia, United States, 24016
    - Carilion Clinic Gynecological Oncology
- Washington
  - Auburn, Washington, United States, 98001
    - MultiCare Auburn Medical Center
  - Centralia, Washington, United States, 98531
    - Providence Regional Cancer System-Centralia
  - Federal Way, Washington, United States, 98003
    - Saint Francis Hospital
  - Lakewood, Washington, United States, 98499
    - Saint Clare Hospital
  - Olympia, Washington, United States, 98506-5166
    - Providence - Saint Peter Hospital
  - Olympia, Washington, United States, 98507
    - Capital Medical Center
  - Puyallup, Washington, United States, 98372
    - MultiCare Good Samaritan Hospital
  - Seattle, Washington, United States, 98195
    - University of Washington Medical Center
  - Seattle, Washington, United States, 98109
    - Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  - Seattle, Washington, United States, 98101
    - Virginia Mason CCOP
  - Tacoma, Washington, United States, 98405
    - Northwest Medical Specialties PLLC
  - Tacoma, Washington, United States, 98431
    - Madigan Army Medical Center
  - Tacoma, Washington, United States, 98405
    - MultiCare Tacoma General Hospital
  - Tacoma, Washington, United States, 98405
    - MultiCare Allenmore Hospital
  - Tacoma, Washington, United States, 98405
    - Saint Joseph Medical Center
  - Tacoma, Washington, United States, 98415
    - MultiCare Health System
  - Tacoma, Washington, United States, 98405
    - Northwest CCOP
- Wisconsin
  - Chippewa Falls, Wisconsin, United States, 54729
    - Marshfield Clinic-Chippewa Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Center at Sacred Heart
  - Eau Claire, Wisconsin, United States, 54701
    - Sacred Heart Hospital
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology Limited at Saint Mary's Hospital
  - Green Bay, Wisconsin, United States, 54303
    - Saint Mary's Hospital
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology at Saint Vincent Hospital
  - Green Bay, Wisconsin, United States, 54311-6519
    - Aurora BayCare Medical Center
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Hospital and Clinics
  - Madison, Wisconsin, United States, 53717
    - Dean Hematology and Oncology Clinic
  - Manitowoc, Wisconsin, United States, 54221
    - Holy Family Memorial Hospital
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Medical Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic
  - Marshfield, Wisconsin, United States, 54449
    - Saint Joseph's Hospital
  - Milwaukee, Wisconsin, United States, 53226
    - Froedtert and The Medical College of Wisconsin
  - Milwaukee, Wisconsin, United States, 53215
    - Medical Consultants Limited
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic-Minocqua Center
  - Oconomowoc, Wisconsin, United States, 53066
    - Oconomowoc Memorial Hospital-ProHealth Care Inc
  - Oconto Falls, Wisconsin, United States, 54154
    - Green Bay Oncology - Oconto Falls
  - Rhinelander, Wisconsin, United States, 54501
    - Marshfield Clinic at James Beck Cancer Center
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic-Rice Lake Center
  - Sheboygan, Wisconsin, United States, 53081
    - Vince Lombardi Cancer Clinic-Sheboygan
  - Slinger, Wisconsin, United States, 53086
    - Vince Lombardi Cancer Clinic - Slinger
  - Stevens Point, Wisconsin, United States, 54481
    - Saint Michael's Hospital
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology - Sturgeon Bay
  - Waukesha, Wisconsin, United States, 53188
    - Waukesha Memorial Hospital
  - West Allis, Wisconsin, United States, 53227
    - Aurora West Allis Medical Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
- Wyoming
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (placebo, paclitaxel, carboplatin) 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.	Other: Laboratory Biomarker Analysis Correlative studies Drug: Carboplatin Given IV Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo Paraplat Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Drug: Paclitaxel Given IV Other Names: Taxol Anzatax Asotax Bristaxol Praxel Taxol Konzentrat Other: Placebo Given IV Other Names: placebo therapy PLCB sham therapy
Experimental: Arm II (placebo, paclitaxel, carboplatin, bevacizumab) 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.	Other: Laboratory Biomarker Analysis Correlative studies Drug: Carboplatin Given IV Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo Paraplat Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Drug: Paclitaxel Given IV Other Names: Taxol Anzatax Asotax Bristaxol Praxel Taxol Konzentrat Biological: Bevacizumab Given IV Other Names: Avastin Anti-VEGF Anti-VEGF Humanized Monoclonal Antibody Anti-VEGF rhuMAb Bevacizumab Biosimilar BEVZ92 Bevacizumab Biosimilar BI 695502 Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer Recombinant Humanized Anti-VEGF Monoclonal Antibody rhuMab-VEGF Other: Placebo Given IV Other Names: placebo therapy PLCB sham therapy
Experimental: Arm III (paclitaxel, carboplatin, bevacizumab) 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.	Other: Laboratory Biomarker Analysis Correlative studies Drug: Carboplatin Given IV Other Names: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo Paraplat Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Drug: Paclitaxel Given IV Other Names: Taxol Anzatax Asotax Bristaxol Praxel Taxol Konzentrat Biological: Bevacizumab Given IV Other Names: Avastin Anti-VEGF Anti-VEGF Humanized Monoclonal Antibody Anti-VEGF rhuMAb Bevacizumab Biosimilar BEVZ92 Bevacizumab Biosimilar BI 695502 Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer Recombinant Humanized Anti-VEGF Monoclonal Antibody rhuMab-VEGF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival Time Frame: From study entry until first disease progression, death or date of last contact, up to 6 years	Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria).	From study entry until first disease progression, death or date of last contact, up to 6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Time Frame: From study entry to death or last contact, up to 6 years	Median overall survival (OS)	From study entry to death or last contact, up to 6 years
Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0 Time Frame: Up to 5 years	Eligible and Evaluable patients	Up to 5 years
Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI) Time Frame: At baseline, 9, 18, 36, 60, and 84 weeks	Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means.	At baseline, 9, 18, 36, 60, and 84 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Collaborators

NRG Oncology

Investigators

Principal Investigator: Robert Burger, NRG Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

December 6, 2005

First Submitted That Met QC Criteria

December 6, 2005

First Posted (Estimate)

December 7, 2005

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 19, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

NCI-2009-00590 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
U10CA180868 (U.S. NIH Grant/Contract)
U10CA027469 (U.S. NIH Grant/Contract)
CDR0000455114
GOG-0218 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Ovarian Endometrioid Adenocarcinoma

Clinical Trials on Laboratory Biomarker Analysis

Search Similar Trials

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Drug Interventions

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Conditions

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