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Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Sponsor: National Cancer Institute (NCI)
Summary
This phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.
Official title: A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
579
Start Date
2016-03-28
Completion Date
2027-03-04
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
Biospecimen Collection
Undergo blood sample collection
Carboplatin
Given IV
Cediranib Maleate
Given PO
Computed Tomography
Undergo CT
Echocardiography Test
Undergo ECHO
Gemcitabine
Given IV
Gemcitabine Hydrochloride
Given IV
Laboratory Biomarker Analysis
Correlative studies
Magnetic Resonance Imaging
Undergo MRI
Multigated Acquisition Scan
Undergo MUGA
Olaparib
Given PO
Paclitaxel
Given IV
Pegylated Liposomal Doxorubicin Hydrochloride
Given IV
Pharmacological Study
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Locations (356)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Arizona Oncology Associates-West Orange Grove
Tucson, Arizona, United States
Arizona Oncology Associates-Wilmot
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
PCR Oncology
Arroyo Grande, California, United States
Mercy San Juan Medical Center
Carmichael, California, United States
Marin Cancer Care Inc
Greenbrae, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Mercy Cancer Center - Sacramento
Sacramento, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Kaiser Permanente-San Francisco
San Francisco, California, United States
UCSF Medical Center-Mission Bay
San Francisco, California, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States
Kaiser Permanente-Vallejo
Vallejo, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
Woodland Memorial Hospital
Woodland, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, United States
Kaiser Permanente-Franklin
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Kaiser Permanente-Rock Creek
Lafayette, Colorado, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Middlesex Hospital
Middletown, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
TidalHealth Nanticoke / Allen Cancer Center
Seaford, Delaware, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States
University Cancer and Blood Center LLC
Athens, Georgia, United States
Piedmont Hospital
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Emory Decatur Hospital
Decatur, Georgia, United States
Atrium Health Navicent
Macon, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States
Rush-Copley Medical Center
Aurora, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
Northwestern University
Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, United States
UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
Chicago, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, 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
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States