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

Who is this study for? Patients with Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Status: Active, not recruiting
Location: See all (358) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: No
View:

• Patients must have platinum-sensitive recurrent high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancers; patients with other (clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma) high-risk histologies are also eligible, provided that the patient has a known deleterious germline BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory; Note: Due to the long acceptance of germline BRCA testing through Myriad, Myriad testing will be accepted; if testing for germline BRCA is done by other organizations, documentation from a qualified medical professional (e.g., ovarian cancer specialty physician involved in the field, high risk genetics physician, genetics counselor) listing the mutation and confirming that the laboratory results showed a recognized germline deleterious BRCA1 or BRCA2 mutation or BRCA rearrangement is required; please collect a copy of Myriad or other BRCA mutational analysis (positive or VUS or negative) reports

• Platinum-sensitive disease defined as no clinical or radiographic evidence of disease recurrence for > 6 months (or 182 days) after last receipt of platinum-based therapy

• Patients must have had a complete clinical response to their prior line of platinum therapy and cannot have had progression through prior platinum-based therapy

• Patients must have signed an approved informed consent and authorization permitting release of personal health information

• Patients must have evaluable disease - defined as one of the following:

• Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable disease OR

• Evaluable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related) AND a cancer antigen 125 (CA125) that has doubled from the post-treatment nadir and is also greater than 2 times upper limit of normal (ULN)

• Prior therapy:

• Prior chemotherapy must have included a first-line platinum-based regimen with or without intravenous consolidation chemotherapy

• Patients may have received an unlimited number of platinum-based therapies in the recurrent setting

• Patients may have received up to 1 non-platinum-based line of therapy in the recurrent setting; prior hormonal therapy will not be considered to count as this non-platinum-based line

• Patients may not have had a prior anti-angiogenic agent in the recurrent setting; prior use of bevacizumab in the upfront or upfront maintenance setting is allowed

• Patients may not have previously received a poly adenosine diphosphate (ADP) ribose polymerase (PARP)-inhibitor

• Prior hormonal-based therapy for ovarian, primary peritoneal, or fallopian tube cancer is acceptable

• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (Karnofsky >= 60%)

• Absolute neutrophil count >= 1,500/mcL

• Platelets >= 100,000/mcL

• Hemoglobin >= 10 g/dL

• Creatinine =< the institutional upper limit of normal (ULN) OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

• Urine protein: creatinine ratio (UPC) of =< 1 or less than or equal to 2+ proteinuria on two consecutive dipsticks taken no less than 1 week apart; UPC is the preferred test; patients with >= 2+ proteinuria on dipstick must also have a 24 hour urine collection demonstrating =< 500 mg over 24 hours

• Total bilirubin =< 1.5 x the institutional ULN

• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 times institutional ULN

• Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE); patients with long-standing stable grade 2 neuropathy may be considered after discussion with the overall principal investigator (PI), but may not receive carboplatin and paclitaxel as the reference regimen, if randomized to that arm

• Patients must be able to swallow and retain oral medications and without gastrointestinal illnesses that would preclude absorption of cediranib or olaparib

• Patients must have adequately controlled blood pressure (BP), with a BP no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility; patients must have a BP of =< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of three antihypertensive medications; it is strongly recommended that patients who are on three antihypertensive medications be followed by a cardiologist or blood pressure specialist for management of blood pressure while on protocol

• Patients must be willing and able to check and record daily blood pressure readings; blood pressure cuffs will be provided to patients randomized to Arm III

• Cediranib has been shown to terminate fetal development in the rat, as expected for a process dependent on VEGF signaling; for this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential must agree to use two reliable forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 weeks after cediranib discontinuation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

• Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid stimulating hormone (TSH) within normal limits

• Age >= 18

Locations
United States
Alaska
Alaska Women's Cancer Care
Anchorage
Providence Alaska Medical Center
Anchorage
Alabama
University of Alabama at Birmingham Cancer Center
Birmingham
University of South Alabama Mitchell Cancer Institute
Mobile
Arkansas
University of Arkansas for Medical Sciences
Little Rock
Arizona
Arizona Oncology Associates-West Orange Grove
Tucson
Arizona Oncology Associates-Wilmot
Tucson
California
PCR Oncology
Arroyo Grande
Mercy San Juan Medical Center
Carmichael
Marin Cancer Care Inc
Greenbrae
UC San Diego Moores Cancer Center
La Jolla
Cedars Sinai Medical Center
Los Angeles
Palo Alto Medical Foundation-Camino Division
Mountain View
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View
Kaiser Permanente-Oakland
Oakland
Palo Alto Medical Foundation Health Care
Palo Alto
Sutter Roseville Medical Center
Roseville
Kaiser Permanente - Sacramento
Sacramento
Mercy Cancer Center - Sacramento
Sacramento
Sutter Medical Center Sacramento
Sacramento
University of California Davis Comprehensive Cancer Center
Sacramento
California Pacific Medical Center-Pacific Campus
San Francisco
Kaiser Permanente-San Francisco
San Francisco
UCSF Medical Center-Mission Bay
San Francisco
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo
Kaiser Permanente Medical Center - Santa Clara
Santa Clara
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz
Sutter Pacific Medical Foundation
Santa Rosa
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale
Kaiser Permanente-Vallejo
Vallejo
Kaiser Permanente-Walnut Creek
Walnut Creek
Woodland Memorial Hospital
Woodland
Colorado
Rocky Mountain Cancer Centers-Aurora
Aurora
University of Colorado Hospital
Aurora
Penrose-Saint Francis Healthcare
Colorado Springs
UCHealth Memorial Hospital Central
Colorado Springs
Kaiser Permanente-Franklin
Denver
Rocky Mountain Cancer Centers-Rose
Denver
Poudre Valley Hospital
Fort Collins
Kaiser Permanente-Rock Creek
Lafayette
Rocky Mountain Cancer Centers-Littleton
Littleton
Kaiser Permanente-Lone Tree
Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree
SCL Health Lutheran Medical Center
Wheat Ridge
Connecticut
Smilow Cancer Hospital Care Center-Fairfield
Fairfield
Hartford Hospital
Hartford
Smilow Cancer Hospital Care Center at Saint Francis
Hartford
Middlesex Hospital
Middletown
The Hospital of Central Connecticut
New Britain
Yale University
New Haven
Smilow Cancer Hospital-Torrington Care Center
Torrington
Smilow Cancer Hospital Care Center-Trumbull
Trumbull
Washington, D.c.
Sibley Memorial Hospital
Washington
Delaware
Christiana Care Health System-Christiana Hospital
Newark
Helen F Graham Cancer Center
Newark
Beebe Health Campus
Rehoboth Beach
TidalHealth Nanticoke / Allen Cancer Center
Seaford
Florida
University of Florida Health Science Center - Gainesville
Gainesville
Georgia
University Cancer and Blood Center LLC
Athens
Northside Hospital
Atlanta
Piedmont Hospital
Atlanta
Dekalb Medical Center
Decatur
Medical Center of Central Georgia
Macon
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah
Memorial Health University Medical Center
Savannah
Hawaii
Kapiolani Medical Center for Women and Children
Honolulu
Queen's Medical Center
Honolulu
Iowa
Medical Oncology and Hematology Associates-West Des Moines
Clive
Mercy Cancer Center-West Lakes
Clive
Iowa Methodist Medical Center
Des Moines
Medical Oncology and Hematology Associates-Des Moines
Des Moines
Mercy Medical Center - Des Moines
Des Moines
Mission Cancer and Blood - Laurel
Des Moines
University of Iowa/Holden Comprehensive Cancer Center
Iowa City
Mercy Medical Center-West Lakes
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Saint Luke's Cancer Institute - Boise
Boise
Saint Luke's Cancer Institute - Fruitland
Fruitland
Saint Luke's Cancer Institute - Meridian
Meridian
Saint Luke's Cancer Institute - Nampa
Nampa
Illinois
Rush - Copley Medical Center
Aurora
Illinois CancerCare-Bloomington
Bloomington
Illinois CancerCare-Canton
Canton
Illinois CancerCare-Carthage
Carthage
Centralia Oncology Clinic
Centralia
John H Stroger Jr Hospital of Cook County
Chicago
Northwestern University
Chicago
Rush University Medical Center
Chicago
UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
Chicago
Cancer Care Specialists of Illinois - Decatur
Decatur
Decatur Memorial Hospital
Decatur
Crossroads Cancer Center
Effingham
Illinois CancerCare-Eureka
Eureka
NorthShore University HealthSystem-Evanston Hospital
Evanston
Illinois CancerCare-Galesburg
Galesburg
Northwestern Medicine Cancer Center Delnor
Geneva
NorthShore University HealthSystem-Glenbrook Hospital
Glenview
NorthShore University HealthSystem-Highland Park Hospital
Highland Park
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale
Illinois CancerCare-Kewanee Clinic
Kewanee
Illinois CancerCare-Macomb
Macomb
Cancer Care Center of O'Fallon
O'fallon
Illinois CancerCare-Ottawa Clinic
Ottawa
Advocate Lutheran General Hospital
Park Ridge
Illinois CancerCare-Pekin
Pekin
Illinois CancerCare-Peoria
Peoria
Illinois CancerCare-Peru
Peru
Illinois CancerCare-Princeton
Princeton
Memorial Medical Center
Springfield
Springfield Clinic
Springfield
Northwestern Medicine Cancer Center Warrenville
Warrenville
Indiana
Ascension Saint Vincent Indianapolis Hospital
Indianapolis
Kansas
University of Kansas Cancer Center
Kansas City
Ascension Via Christi - Pittsburg
Pittsburg
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka
Ascension Via Christi Hospitals Wichita
Wichita
Associates In Womens Health
Wichita
Kentucky
University of Kentucky/Markey Cancer Center
Lexington
Norton Brownsboro Hospital and Medical Campus
Louisville
Norton Hospital Pavilion and Medical Campus
Louisville
Norton Suburban Hospital and Medical Campus
Louisville
Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge
Woman's Hospital
Baton Rouge
Women's Cancer Care-Covington
Covington
Ochsner Medical Center Jefferson
New Orleans
Massachusetts
Brigham and Women's Hospital
Boston
Dana-Farber Cancer Institute
Boston
Tufts Medical Center
Boston
Lahey Hospital and Medical Center
Burlington
Maryland
Greater Baltimore Medical Center
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore
University of Maryland Shore Medical Center at Easton
Easton
Maine
Eastern Maine Medical Center
Bangor
Lafayette Family Cancer Center-EMMC
Brewer
Maine Medical Center- Scarborough Campus
Scarborough
Michigan
Saint Joseph Mercy Hospital
Ann Arbor
University of Michigan Comprehensive Cancer Center
Ann Arbor
Henry Ford Cancer Institute-Downriver
Brownstown
Henry Ford Macomb Hospital-Clinton Township
Clinton Township
Henry Ford Hospital
Detroit
Wayne State University/Karmanos Cancer Institute
Detroit
Green Bay Oncology - Escanaba
Escanaba
Weisberg Cancer Treatment Center
Farmington Hills
Genesys Hurley Cancer Institute
Flint
Hurley Medical Center
Flint
Spectrum Health at Butterworth Campus
Grand Rapids
West Michigan Cancer Center
Kalamazoo
Sparrow Hospital
Lansing
Green Bay Oncology-Manistique
Manistique
Saint Joseph Mercy Oakland
Pontiac
Ascension Providence Hospitals - Southfield
Southfield
Munson Medical Center
Traverse City
Henry Ford West Bloomfield Hospital
West Bloomfield
Minnesota
Sanford Joe Lueken Cancer Center
Bemidji
Fairview Ridges Hospital
Burnsville
Mercy Hospital
Coon Rapids
Fairview Southdale Hospital
Edina
Mayo Clinic Health Systems-Mankato
Mankato
Fairview Clinics and Surgery Center Maple Grove
Maple Grove
Saint John's Hospital - Healtheast
Maplewood
Abbott-Northwestern Hospital
Minneapolis
University of Minnesota/Masonic Cancer Center
Minneapolis
Mayo Clinic in Rochester
Rochester
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park
Regions Hospital
Saint Paul
United Hospital
Saint Paul
Saint Francis Regional Medical Center
Shakopee
Minnesota Oncology Hematology PA-Woodbury
Woodbury
Missouri
Saint Francis Medical Center
Cape Girardeau
Mercy Hospital Joplin
Joplin
Barnes-Jewish Hospital
Saint Louis
Washington University School of Medicine
Saint Louis
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Mississippi
Saint Dominic-Jackson Memorial Hospital
Jackson
University of Mississippi Medical Center
Jackson
Montana
Billings Clinic Cancer Center
Billings
Benefis Healthcare- Sletten Cancer Institute
Great Falls
Kalispell Regional Medical Center
Kalispell
Community Medical Hospital
Missoula
North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill
Duke University Medical Center
Durham
Southeastern Medical Oncology Center-Goldsboro
Goldsboro
Southeastern Medical Oncology Center-Jacksonville
Jacksonville
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst
Duke Raleigh Hospital
Raleigh
Novant Health New Hanover Regional Medical Center
Wilmington
Wake Forest University Health Sciences
Winston-salem
North Dakota
Sanford Bismarck Medical Center
Bismarck
Sanford Broadway Medical Center
Fargo
Sanford Roger Maris Cancer Center
Fargo
Trinity Cancer Care Center
Minot
Nebraska
CHI Health Saint Francis
Grand Island
CHI Health Good Samaritan
Kearney
Alegent Health Bergan Mercy Medical Center
Omaha
Alegent Health Lakeside Hospital
Omaha
Nebraska Methodist Hospital
Omaha
New Hampshire
Wentworth-Douglass Hospital
Dover
Dartmouth Hitchcock Medical Center
Lebanon
Norris Cotton Cancer Center-Nashua
Nashua
New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge
Cooper Hospital University Medical Center
Camden
Englewood Hospital and Medical Center
Englewood
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees
New Mexico
Southwest Gynecologic Oncology Associates Inc
Albuquerque
University of New Mexico Cancer Center
Albuquerque
Memorial Medical Center - Las Cruces
Las Cruces
Nevada
Women's Cancer Center of Nevada
Las Vegas
New York
Montefiore Medical Center-Einstein Campus
Bronx
State University of New York Downstate Medical Center
Brooklyn
Roswell Park Cancer Institute
Buffalo
Memorial Sloan Kettering Commack
Commack
Memorial Sloan Kettering Westchester
Harrison
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
Memorial Sloan Kettering Cancer Center
New York
University of Rochester
Rochester
Memorial Sloan Kettering Nassau
Uniondale
Dickstein Cancer Treatment Center
White Plains
Ohio
Cleveland Clinic Akron General
Akron
Summa Health System - Akron Campus
Akron
UHHS-Chagrin Highlands Medical Center
Beachwood
Good Samaritan Hospital - Cincinnati
Cincinnati
TriHealth Cancer Institute-Westside
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati
Case Western Reserve University
Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland
Cleveland Clinic Foundation
Cleveland
MetroHealth Medical Center
Cleveland
Columbus Oncology and Hematology Associates Inc
Columbus
Ohio State University Comprehensive Cancer Center
Columbus
Riverside Methodist Hospital
Columbus
The Mark H Zangmeister Center
Columbus
Grandview Hospital
Dayton
Orion Cancer Care
Findlay
Hillcrest Hospital Cancer Center
Mayfield Heights
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor
ProMedica Flower Hospital
Sylvania
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo
University Hospitals Sharon Health Center
Wadsworth
UHHS-Westlake Medical Center
Westlake
Wright-Patterson Medical Center
Wright-patterson Air Force Base
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa
Oregon
Saint Charles Health System
Bend
Willamette Valley Cancer Center
Eugene
Legacy Mount Hood Medical Center
Gresham
Kaiser Permanente Northwest
Portland
Legacy Good Samaritan Hospital and Medical Center
Portland
Legacy Meridian Park Hospital
Tualatin
Pennsylvania
Jefferson Abington Hospital
Abington
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem
Geisinger Medical Center
Danville
Ephrata Cancer Center
Ephrata
Adams Cancer Center
Gettysburg
Lancaster General Hospital
Lancaster
Thomas Jefferson University Hospital
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Philadelphia
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
West Penn Hospital
Pittsburgh
Guthrie Medical Group PC-Robert Packer Hospital
Sayre
Geisinger Medical Oncology-Selinsgrove
Selinsgrove
Reading Hospital
West Reading
UPMC Susquehanna
Williamsport
WellSpan Health-York Hospital
York
Rhode Island
Women and Infants Hospital
Providence
South Carolina
AnMed Health Cancer Center
Anderson
Medical University of South Carolina
Charleston
Gibbs Cancer Center-Gaffney
Gaffney
Prisma Health Cancer Institute - Faris
Greenville
Saint Francis Cancer Center
Greenville
Saint Francis Hospital
Greenville
Gibbs Cancer Center-Pelham
Greer
South Carolina Cancer Specialists PC
Hilton Head Island
Spartanburg Medical Center
Spartanburg
MGC Hematology Oncology-Union
Union
South Dakota
Rapid City Regional Hospital
Rapid City
Avera Cancer Institute
Sioux Falls
Sanford Cancer Center Oncology Clinic
Sioux Falls
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Tennessee
Wellmont Medical Associates Oncology and Hematology-Johnson City
Johnson City
Ballad Health Cancer Care - Kingsport
Kingsport
Wellmont Holston Valley Hospital and Medical Center
Kingsport
Thompson Cancer Survival Center
Knoxville
Thompson Cancer Survival Center - West
Knoxville
Vanderbilt University/Ingram Cancer Center
Nashville
Texas
Texas Oncology - Central Austin Cancer Center
Austin
Texas Oncology - South Austin Cancer Center
Austin
Texas Oncology Bedford
Bedford
Parkland Memorial Hospital
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
Texas Oncology - Fort Worth Cancer Center
Fort Worth
Houston Methodist Hospital
Houston
Methodist Willowbrook Hospital
Houston
Houston Methodist Sugar Land Hospital
Sugar Land
Texas Oncology-The Woodlands
The Woodlands
Utah
Intermountain Medical Center
Murray
Saint George Regional Medical Center
Saint George
Utah Cancer Specialists-Salt Lake City
Salt Lake City
Virginia
University of Virginia Cancer Center
Charlottesville
Virginia Commonwealth University/Massey Cancer Center
Richmond
Washington
Kadlec Clinic Hematology and Oncology
Kennewick
Skagit Regional Health Cancer Care Center
Mount Vernon
Skagit Valley Hospital
Mount Vernon
FHCC South Lake Union
Seattle
Fred Hutchinson Cancer Research Center
Seattle
Pacific Gynecology Specialists
Seattle
Swedish Medical Center-First Hill
Seattle
University of Washington Medical Center - Montlake
Seattle
University of Washington Medical Center - Northwest
Seattle
Women's Cancer Center of Seattle
Seattle
Legacy Salmon Creek Hospital
Vancouver
Wenatchee Valley Hospital and Clinics
Wenatchee
Wisconsin
Marshfield Clinic-Chippewa Center
Chippewa Falls
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Green Bay
Gundersen Lutheran Medical Center
La Crosse
Marshfield Clinic - Ladysmith Center
Ladysmith
University of Wisconsin Carbone Cancer Center
Madison
Saint Vincent Hospital Cancer Center at Marinette
Marinette
Marshfield Medical Center-Marshfield
Marshfield
Medical College of Wisconsin
Milwaukee
Marshfield Clinic-Minocqua Center
Minocqua
ProHealth D N Greenwald Center
Mukwonago
ProHealth Oconomowoc Memorial Hospital
Oconomowoc
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls
Marshfield Medical Center-Rice Lake
Rice Lake
Ascension Saint Michael's Hospital
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Stevens Point
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay
ProHealth Waukesha Memorial Hospital
Waukesha
UW Cancer Center at ProHealth Care
Waukesha
Marshfield Clinic-Wausau Center
Wausau
Marshfield Medical Center - Weston
Weston
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids
West Virginia
West Virginia University Charleston Division
Charleston
Edwards Comprehensive Cancer Center
Huntington
Other Locations
Canada
Tom Baker Cancer Centre
Calgary
Cross Cancer Institute
Edmonton
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton
London Regional Cancer Program
London
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal
CHUM - Hopital Notre-Dame
Montreal
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
Montreal
Jewish General Hospital
Montreal
Ottawa Hospital and Cancer Center-General Campus
Ottawa
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Quebec City
Algoma District Cancer Program Sault Area Hospital
Sault Ste Marie
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto
University Health Network-Princess Margaret Hospital
Toronto
Japan
Kagoshima City Hospital
Kagoshima City
The Cancer Institute Hospital Of JFCR
Koto-ku
Saitama Medical University International Medical Center
Saitama
Iwate Medical University Hospital
Shiwa-gun
National Cancer Center Hospital
Tokyo
Republic of Korea
Seoul National University Hospital
Seoul
Time Frame
Start Date: February 4, 2016
Estimated Completion Date: December 30, 2023
Participants
Target number of participants: 579
Treatments
Active Comparator: Arm I (platinum-based chemotherapy)
REGIMEN I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.~REGIMEN II: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 for at least 4 cycles in the absence of disease progression or unacceptable toxicity.~REGIMEN III: Patients receive pegylated liposomal doxorubicin hydrochloride IV and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 28 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II (olaparib)
Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Experimental: Arm III (olaparib, cediranib maleate)
Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Authors
John O. Schorge, Nicole S. Nevadunsky, Merry J. Markham, Benjamin B. Bridges, Donald P. Seago, Ovadia Abulafia, Michael J. Callahan, Kristin K. Zorn, Walter H. Gajewski, David P. Warshal, Bhavana Pothuri, Stefanie M. Ueda, Nimesh P. Nagarsheth, Michael A. Bookman, Lori E. Weinberg, Adam W. Nowlan, Ira A. Oliff, Robert J. Behrens, Michael J. Sundborg, Carolyn Y. Muller, Thomas H. Openshaw, Heidi J. Gray, Paul G. Montgomery, Whitney S. Graybill, David G. Mutch, Dan Costin, Ramey D. Littell, Thomas J. Reid, James E. Hunter, Philip A. Lowry, David P. Bender, Keyur B. Thakar, William P. Tew, David Griffin, David C. Starks, Asheesh Shipstone, Neela Natarajan, Howard M. Gross, Jay W. Carlson, Leslie R. DeMars, Emily M. Ko, Pallavi P. Kumar, Steven J. Jubelirer, Thomas C. Krivak, Mehmet S. Copur, Peter D. Eisenberg, Maria C. Bell, Bobbie J. Rimel, Jennifer M. Scalici, Joyce Liu, Julia A. Chapman, Summer B. Dewdney, Delphine W. Ong, Timothy R. Wassenaar, Steven E. Waggoner, Howard A. Zaren, Katrina S. Wade, Charles A. Leath, Thomas E. Lad, Russell J. Schilder, Timothy D. Moore, Kimberly E. Resnick, James N. Atkins, Mehmood H. Hashmi, Linda R. Duska, Abdul H. Mansoor, Brent J. Tierney, Gregory A. Masters, Keren Sturtz, Deborah K. Armstrong, Susannah C. Cooper, David G. McIntosh, Mark A. Miller, Gregory J. Litton, Kendrith M. Rowland, Michael T. McHale, Janet G. Turner, Lisa M. Barroilhet, Thomas E. Buekers, Stephen N. Makoni, Joel I. Sorosky, Alexander Menter, David M. O'Malley, Corrine L. Zarwan, Vanessa A. Kennedy, Eric L. Eisenhauer, Barbara M. Buttin, Shohreh Shahabi, Marta A. Crispens, Adam C. Walter, Jean A. Hurteau, Michael J. Swartz, Terrence P. Cescon, Rachel E. Lerner, Jeffrey W. Elder, Peter G. Rose, Stephanie V. Blank, Carolyn M. Johnston, Nicholas P. Taylor, M. G. Fort, Saketh R. Guntupalli, Sudarshan K. Sharma, Paul Celano, Peter C. Morris, Anthony C. Evans, Shaker R. Dakhil, Mary E. Gordinier, Michael E. Carney, Brian A. DiCarlo, Aparna A. Kamat, Angeles A. Secord, Linda Van Le, Colleen C. McCormick, Jamie N. Bakkum-Gamez, Frederick R. Ueland, Parviz Hanjani, Paul A. DiSilvestro, James L. Wade, Benjamin T. Marchello, Jayanthi S. Lea, Vinay K. Malviya, Timothy M. Lestingi, Peter E. Schwartz, Augusto C. Ochoa, Richard G. Moore, Young B. Kim, Warren L. Robinson, Gretchen E. Glaser, Robert S. Mannel, Jonathan E. Tammela, Alexander B. Olawaiye, Susanna Hong, Kelly J. Wilkinson, Nicola M. Spirtos, Stephen J. Andrews, Patricia S. Braly, Brook A. Saunders, Yovanni Casablanca, Esther H. Rehmus, Michael P. Fung Kee Fung, Caitlin J. Stashwick, Stephen A. Welch, Stephanie Lheureux, James J. Burke, William E. Winter, Amy K. Brown, Toshiaki Nakamura, Susie K. Lau, Suzanne Fortin, Shashikant B. Lele, Jae W. Kim, Prafull Ghatage, Maria R. Tria Tirona, Sharad A. Ghamande, Melissa A. Geller, Mary S. De Shields, J. R. Liu, Guilherme Henrique C. Cantuaria, Robert T. Morris, Stacy D. D'Andre, Samuel S. Lentz, Kathleen J. Yost, John A. Ellerton, Lua R. Eiriksson, Vincent Castonguay, Ioannis A. Voutsadakis, William H. Bradley, Hiroyuki Yoshida, Satoshi Takeuchi, Helen J. Mackay, Radhika P. Gogoi, Katia S. Tonkin, Diane M. Provencher, Paul Bessette, William P. McGuire, Kan Yonemori, Shunji Takahashi, John K. Chan, Christopher J. Darus
Sponsors
Collaborators: NRG Oncology, AstraZeneca
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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