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COMPLETED
NCT00951496
PHASE3

Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This randomized phase III trial studies bevacizumab and intravenous (given into a vein) chemotherapy to see how well they work compared with bevacizumab and intraperitoneal (given into the abdominal cavity) chemotherapy in treating patients with stage II-III ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Monoclonal antibodies, such as bevacizumab, can block the ability of tumor cells to grow and spread by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving bevacizumab together with intravenous chemotherapy is more effective than giving bevacizumab together with intraperitoneal chemotherapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Official title: A Phase III Clinical Trial of Bevacizumab With IV Versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1560

Start Date

2009-08-11

Completion Date

2016-01-11

Last Updated

2026-06-02

Healthy Volunteers

No

Conditions

Fallopian Tube Clear Cell AdenocarcinomaFallopian Tube Endometrioid AdenocarcinomaFallopian Tube Mucinous AdenocarcinomaFallopian Tube Serous AdenocarcinomaFallopian Tube Transitional Cell CarcinomaFallopian Tube Undifferentiated CarcinomaMalignant Ovarian Brenner TumorOvarian Clear Cell AdenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Mucinous AdenocarcinomaOvarian Seromucinous CarcinomaOvarian Serous AdenocarcinomaOvarian Transitional Cell CarcinomaOvarian Undifferentiated CarcinomaPrimary Peritoneal Clear Cell AdenocarcinomaPrimary Peritoneal Endometrioid AdenocarcinomaPrimary Peritoneal Serous AdenocarcinomaPrimary Peritoneal Transitional Cell CarcinomaPrimary Peritoneal Undifferentiated CarcinomaStage II Fallopian Tube Cancer AJCC v6 and v7Stage II Ovarian Cancer AJCC v6 and v7Stage IIA Fallopian Tube Cancer AJCC v6 and v7Stage IIA Ovarian Cancer AJCC V6 and v7Stage IIB Fallopian Tube Cancer AJCC v6 and v7Stage IIB Ovarian Cancer AJCC v6 and v7Stage IIC Fallopian Tube Cancer AJCC v6 and v7Stage IIC Ovarian Cancer AJCC v6 and v7Stage III Ovarian Cancer AJCC v6 and v7Stage III Primary Peritoneal Cancer AJCC v7Stage IIIA Ovarian Cancer AJCC v6 and v7Stage IIIA Primary Peritoneal Cancer AJCC v7Stage IIIB Ovarian Cancer AJCC v6 and v7Stage IIIB Primary Peritoneal Cancer AJCC v7Stage IIIC Ovarian Cancer AJCC v6 and v7Stage IIIC Primary Peritoneal Cancer AJCC v7Stage IV Fallopian Tube Cancer AJCC v6 and v7Stage IV Ovarian Cancer AJCC v6 and v7Stage IV Primary Peritoneal Cancer AJCC v7

Interventions

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Carboplatin

Given IV

DRUG

Carboplatin

Given IP

DRUG

Cisplatin

Given IP

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Paclitaxel

Given IV

DRUG

Paclitaxel

Given IP

OTHER

Quality-of-Life Assessment

Ancillary studies

Locations (503)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Saint Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

PCR Oncology

Arroyo Grande, California, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Mills-Peninsula Medical Center

Burlingame, California, United States

John Muir Medical Center-Concord Campus

Concord, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Marin General Hospital

Greenbrae, California, United States

Long Beach Memorial Medical Center-Todd Cancer Institute

Long Beach, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Palo Alto Medical Foundation-Gynecologic Oncology

Mountain View, California, United States

Sutter Cancer Research Consortium

Novato, California, United States

Saint Joseph Hospital - Orange

Orange, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Sutter Roseville Medical Center

Roseville, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

University of California San Diego

San Diego, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

UCSF Medical Center-Mount Zion

San Francisco, California, United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

John Muir Medical Center-Walnut Creek

Walnut Creek, California, United States

Colorado Gynecologic Oncology Group

Aurora, Colorado, United States

University of Colorado Hospital

Aurora, Colorado, United States

University of Colorado

Denver, Colorado, United States

Rocky Mountain Gynecologic Oncology PC

Englewood, Colorado, United States

Danbury Hospital

Danbury, Connecticut, United States

Hartford Hospital

Hartford, Connecticut, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Stamford Hospital/Bennett Cancer Center

Stamford, Connecticut, United States

Beebe Medical Center

Lewes, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Morton Plant Hospital

Clearwater, Florida, United States

Florida Gynecologic Oncology

Fort Myers, Florida, United States

Saint Vincent's Medical Center

Jacksonville, Florida, United States

Southeast Gynecologic Oncology Associates

Jacksonville, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

The Watson Clinic

Lakeland, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Bayfront Outpatient Health Clinic

St. Petersburg, Florida, United States

Women's Cancer Associates

St. Petersburg, Florida, United States

Northside Hospital

Atlanta, Georgia, United States

John B Amos Cancer Center

Columbus, Georgia, United States

Northeast Georgia Medical Center-Gainesville

Gainesville, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

Queen's Medical Center

Honolulu, Hawaii, United States

Straub Clinic and Hospital

Honolulu, Hawaii, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Wilcox Memorial Hospital and Kauai Medical Clinic

Lihue, Hawaii, United States

Maui Memorial Medical Center

Wailuku, Hawaii, United States

Pacific Cancer Institute of Maui

Wailuku, Hawaii, United States

Pali Momi Medical Center

‘Aiea, Hawaii, United States

Kootenai Cancer Center

Post Falls, Idaho, United States

Saint Joseph Medical Center

Bloomington, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Graham Hospital Association

Canton, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Memorial Hospital

Carthage, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Presence Resurrection Medical Center

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Heartland Cancer Research NCORP

Decatur, Illinois, United States

Advocate Sherman Hospital

Elgin, Illinois, United States

Eureka Hospital

Eureka, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Illinois CancerCare-Cottage

Galesburg, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Illinois CancerCare-Havana

Havana, Illinois, United States

Mason District Hospital

Havana, Illinois, United States

Hinsdale Hematology Oncology Associates Incorporated

Hinsdale, Illinois, United States

Sudarshan K Sharma MD Limited-Gynecologic Oncology

Hinsdale, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Mcdonough District Hospital

Macomb, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Holy Family Medical Center

Monmouth, Illinois, United States

Illinois CancerCare-Monmouth

Monmouth, Illinois, United States

And 403 more locations on ClinicalTrials.gov