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ACTIVE NOT RECRUITING
NCT02446600
PHASE3

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)

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Carboplatin

Given IV

DRUG

Cediranib Maleate

Given PO

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Echocardiography Test

Undergo ECHO

DRUG

Gemcitabine

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Olaparib

Given PO

DRUG

Paclitaxel

Given IV

DRUG

Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

OTHER

Pharmacological Study

Correlative studies

OTHER

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

And 256 more locations on ClinicalTrials.gov