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Testen van het gebruik van één enkel geneesmiddel (Olaparib) of de combinatie van twee geneesmiddelen (Cediranib en Olaparib) in vergelijking met de gebruikelijke chemotherapie voor vrouwen met platinagevoelige ovarium-, eileider- of primaire peritoneale kanker

30 september 2026 bijgewerkt door: National Cancer Institute (NCI)

Een fase III-studie waarin olaparib als enkelvoudig middel of de combinatie van cediranib en olaparib wordt vergeleken met standaard op platina gebaseerde chemotherapie bij vrouwen met recidiverende platinagevoelige ovarium-, eileider- of primaire peritoneale kanker

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

PRIMARY OBJECTIVE:

I. Assess the efficacy of either single agent olaparib or the combination of cediranib (cediranib maleate) and olaparib, as measured by progression free survival (PFS), as compared to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.

SECONDARY OBJECTIVES:

I. Assess the efficacy of single agent olaparib or the combination of cediranib and olaparib, as measured by response rate and overall survival as compared to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.

II. Assess the efficacy of single agent olaparib or the combination of cediranib and olaparib, as measured by PFS, in women with or without deleterious germline breast cancer (BRCA) mutations (gBRCAmt) in the setting of recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer.

III. Assess the effect on disease-related symptoms (DRS) as measured by the 9-item DRS-P subscale of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) Ovarian Symptom Index-18 (NFOSI-18), of single agent olaparib or cediranib and olaparib, compared to standard platinum-based chemotherapy, in the setting of recurrent platinum sensitive ovarian, primary peritoneal or fallopian tube cancer.

IV. Assess the efficacy of single agent olaparib or the combination of cediranib and olaparib, as measured by PFS, in women with or without homologous repair deficiencies as measured by BROCA in the setting of recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer.

V. To assess changes in the number of circulating endothelial cells (CECs) following three days of treatment with olaparib, combination olaparib/cediranib, or standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer.

VI. To assess whether change in the number of circulating endothelial cells (CECs) following three days of treatment with olaparib, combination olaparib/cediranib, or standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer is prognostic for PFS.

VII. To develop a profile from a panel of angiogenic biomarkers in women with recurrent platinum-sensitive ovarian, primary peritoneal, or fallopian tube cancer which is associated with PFS, and then validate the predictive value of this biomarker profile.

EXPLORATORY OBJECTIVES:

I. To assess the time from randomization to the first non-study, anti-cancer therapy, surgery or death (TFST) for single-agent olaparib or combination cediranib and olaparib relative to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.

II. To assess the time from randomization to the second non-study, anti-cancer therapy, surgery or death (TSST) for single-agent olaparib or combination cediranib and olaparib relative to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.

III. Assess the effect on secondary measures of quality of life, as assessed by the treatment side effects (TSE) and function/well-being (F/WB) subscales of the NFOSI-18, sensory neuropathy as measured by the FACT/Gynecologic Oncology Group-Neurotoxicity version 4 (GOG-Ntx-4), and health utility as measured by the Euro Quality of Life-5 Dimension (EQ-5D), of single agent olaparib or cediranib and olaparib, compared to standard platinum-based chemotherapy, in the setting of recurrent platinum sensitive ovarian, primary peritoneal or fallopian tube cancer.

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

ARM I: Patients may be treated with one of the three regimens per investigator discretion.

REGIMEN I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30-60 minutes and on day 1. Treatment repeats every 21 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) as well as blood sample collection throughout the trial.

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. Patients undergo ECHO or MUGA during screening. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.

REGIMEN III: Patients receive pegylated liposomal doxorubicin hydrochloride IV and carboplatin IV over 30-60 minutes and on day 1. Treatment repeats every 28 days for at least 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.

ARM II: Patients receive olaparib orally (PO) twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.

ARM III: Patients receive olaparib PO BID and cediranib maleate PO once daily (QD). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.

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

Studietype

Ingrijpend

Inschrijving (Werkelijk)

579

Fase

  • Fase 3

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Studie Locaties

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital and Cancer Center-General Campus
      • Sault Ste. Marie, Ontario, Canada, P6B 0A8
        • Algoma District Cancer Program Sault Area Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network-Princess Margaret Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Odette Cancer Centre- Sunnybrook Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM - Centre Hospitalier de l'Universite de Montreal
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSSEMTL-Hopital Maisonneuve-Rosemont
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
  • Japan
      • Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center
      • Tokyo, Japan, 104 0045
        • National Cancer Center Hospital
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Iwate Medical University Hospital
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-8760
        • Kagoshima City Hospital
    • Tokyo
      • Koto-ku, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital Of JFCR
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35233
        • University of Alabama at Birmingham Cancer Center
      • Mobile, Alabama, Verenigde Staten, 36688
        • University of South Alabama Mitchell Cancer Institute
    • Alaska
      • Anchorage, Alaska, Verenigde Staten, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Verenigde Staten, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Tucson, Arizona, Verenigde Staten, 85704
        • Arizona Oncology Associates-West Orange Grove
      • Tucson, Arizona, Verenigde Staten, 85710
        • Arizona Oncology Associates-Wilmot
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Arroyo Grande, California, Verenigde Staten, 93420
        • PCR Oncology
      • Carmichael, California, Verenigde Staten, 95608
        • Mercy San Juan Medical Center
      • Greenbrae, California, Verenigde Staten, 94904
        • Marin Cancer Care Inc
      • La Jolla, California, Verenigde Staten, 92093
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, Verenigde Staten, 90048
        • Cedars-Sinai Medical Center
      • Mountain View, California, Verenigde Staten, 94040
        • Palo Alto Medical Foundation-Camino Division
      • Mountain View, California, Verenigde Staten, 94040
        • Palo Alto Medical Foundation-Gynecologic Oncology
      • Oakland, California, Verenigde Staten, 94611
        • Kaiser Permanente-Oakland
      • Palo Alto, California, Verenigde Staten, 94301
        • Palo Alto Medical Foundation Health Care
      • Roseville, California, Verenigde Staten, 95661
        • Sutter Roseville Medical Center
      • Sacramento, California, Verenigde Staten, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, Verenigde Staten, 95817
        • University of California Davis Comprehensive Cancer Center
      • Sacramento, California, Verenigde Staten, 95825
        • Kaiser Permanente Sacramento Medical Center
      • Sacramento, California, Verenigde Staten, 95816
        • Mercy Cancer Center - Sacramento
      • San Francisco, California, Verenigde Staten, 94115
        • Kaiser Permanente-San Francisco
      • San Francisco, California, Verenigde Staten, 94158
        • UCSF Medical Center-Mission Bay
      • San Francisco, California, Verenigde Staten, 94115
        • California Pacific Medical Center-Pacific Campus
      • San Luis Obispo, California, Verenigde Staten, 93401
        • Pacific Central Coast Health Center-San Luis Obispo
      • Santa Clara, California, Verenigde Staten, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Cruz, California, Verenigde Staten, 95065
        • Palo Alto Medical Foundation-Santa Cruz
      • Santa Rosa, California, Verenigde Staten, 95403
        • Sutter Pacific Medical Foundation
      • Sunnyvale, California, Verenigde Staten, 94086
        • Palo Alto Medical Foundation-Sunnyvale
      • Vallejo, California, Verenigde Staten, 94589
        • Kaiser Permanente-Vallejo
      • Walnut Creek, California, Verenigde Staten, 94596
        • Kaiser Permanente-Walnut Creek
      • Woodland, California, Verenigde Staten, 95695
        • Woodland Memorial Hospital
    • Colorado
      • Aurora, Colorado, Verenigde Staten, 80012
        • Rocky Mountain Cancer Centers-Aurora
      • Aurora, Colorado, Verenigde Staten, 80045
        • UCHealth University of Colorado Hospital
      • Colorado Springs, Colorado, Verenigde Staten, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, Verenigde Staten, 80909
        • UCHealth Memorial Hospital Central
      • Denver, Colorado, Verenigde Staten, 80205
        • Kaiser Permanente-Franklin
      • Denver, Colorado, Verenigde Staten, 80220
        • Rocky Mountain Cancer Centers-Rose
      • Fort Collins, Colorado, Verenigde Staten, 80524
        • Poudre Valley Hospital
      • Lafayette, Colorado, Verenigde Staten, 80026
        • Kaiser Permanente-Rock Creek
      • Littleton, Colorado, Verenigde Staten, 80120
        • Rocky Mountain Cancer Centers-Littleton
      • Lone Tree, Colorado, Verenigde Staten, 80124
        • Kaiser Permanente-Lone Tree
      • Lone Tree, Colorado, Verenigde Staten, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Wheat Ridge, Colorado, Verenigde Staten, 80401
        • Intermountain Health Lutheran Hospital
    • Connecticut
      • Fairfield, Connecticut, Verenigde Staten, 06824
        • Smilow Cancer Hospital Care Center-Fairfield
      • Hartford, Connecticut, Verenigde Staten, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • Hartford, Connecticut, Verenigde Staten, 06102
        • Hartford Hospital
      • Middletown, Connecticut, Verenigde Staten, 06457
        • Middlesex Hospital
      • New Britain, Connecticut, Verenigde Staten, 06050
        • The Hospital of Central Connecticut
      • New Haven, Connecticut, Verenigde Staten, 06520
        • Yale University
      • Torrington, Connecticut, Verenigde Staten, 06790
        • Smilow Cancer Hospital-Torrington Care Center
      • Trumbull, Connecticut, Verenigde Staten, 06611
        • Smilow Cancer Hospital Care Center-Trumbull
    • Delaware
      • Newark, Delaware, Verenigde Staten, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, Verenigde Staten, 19718
        • Christiana Care Health System-Christiana Hospital
      • Rehoboth Beach, Delaware, Verenigde Staten, 19971
        • Beebe Health Campus
      • Seaford, Delaware, Verenigde Staten, 19973
        • TidalHealth Nanticoke / Allen Cancer Center
    • District of Columbia
      • Washington D.C., District of Columbia, Verenigde Staten, 20016
        • Sibley Memorial Hospital
    • Florida
      • Gainesville, Florida, Verenigde Staten, 32610
        • UF Health Cancer Institute - Gainesville
    • Georgia
      • Athens, Georgia, Verenigde Staten, 30607
        • University Cancer and Blood Center LLC
      • Atlanta, Georgia, Verenigde Staten, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, Verenigde Staten, 30342
        • Northside Hospital
      • Decatur, Georgia, Verenigde Staten, 30033
        • Emory Decatur Hospital
      • Macon, Georgia, Verenigde Staten, 31201
        • Atrium Health Navicent
      • Savannah, Georgia, Verenigde Staten, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
      • Savannah, Georgia, Verenigde Staten, 31404
        • Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, Verenigde Staten, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, Verenigde Staten, 96826
        • Kapiolani Medical Center for Women and Children
    • Idaho
      • Boise, Idaho, Verenigde Staten, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise, Idaho, Verenigde Staten, 83712
        • Saint Luke's Cancer Institute - Boise
      • Fruitland, Idaho, Verenigde Staten, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, Verenigde Staten, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, Verenigde Staten, 83687
        • Saint Luke's Cancer Institute - Nampa
    • Illinois
      • Aurora, Illinois, Verenigde Staten, 60504
        • Rush-Copley Medical Center
      • Bloomington, Illinois, Verenigde Staten, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, Verenigde Staten, 61520
        • Illinois CancerCare-Canton
      • Carthage, Illinois, Verenigde Staten, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, Verenigde Staten, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, Verenigde Staten, 60611
        • Northwestern University
      • Chicago, Illinois, Verenigde Staten, 60612
        • John H Stroger Jr Hospital of Cook County
      • Chicago, Illinois, Verenigde Staten, 60657
        • UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
      • Chicago, Illinois, Verenigde Staten, 60612
        • Rush MD Anderson Cancer Center
      • Decatur, Illinois, Verenigde Staten, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, Verenigde Staten, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Effingham, Illinois, Verenigde Staten, 62401
        • Crossroads Cancer Center
      • Eureka, Illinois, Verenigde Staten, 61530
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, Verenigde Staten, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, Verenigde Staten, 61401
        • Illinois CancerCare-Galesburg
      • Geneva, Illinois, Verenigde Staten, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Glenview, Illinois, Verenigde Staten, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Highland Park, Illinois, Verenigde Staten, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Hinsdale, Illinois, Verenigde Staten, 60521
        • Sudarshan K Sharma MD Limited-Gynecologic Oncology
      • Kewanee, Illinois, Verenigde Staten, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, Verenigde Staten, 61455
        • Illinois CancerCare-Macomb
      • O'Fallon, Illinois, Verenigde Staten, 62269
        • Cancer Care Center of O'Fallon
      • Ottawa, Illinois, Verenigde Staten, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Park Ridge, Illinois, Verenigde Staten, 60068
        • Advocate Lutheran General Hospital
      • Pekin, Illinois, Verenigde Staten, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, Verenigde Staten, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, Verenigde Staten, 61354
        • Illinois CancerCare-Peru
      • Princeton, Illinois, Verenigde Staten, 61356
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, Verenigde Staten, 62702
        • Springfield Clinic
      • Springfield, Illinois, Verenigde Staten, 62781
        • Springfield Memorial Hospital
      • Warrenville, Illinois, Verenigde Staten, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46260
        • Ascension Saint Vincent Indianapolis Hospital
    • Iowa
      • Clive, Iowa, Verenigde Staten, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, Verenigde Staten, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Des Moines, Iowa, Verenigde Staten, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Verenigde Staten, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Verenigde Staten, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Des Moines, Iowa, Verenigde Staten, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • Iowa City, Iowa, Verenigde Staten, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • West Des Moines, Iowa, Verenigde Staten, 50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Kansas City, Kansas, Verenigde Staten, 66160
        • University of Kansas Cancer Center
      • Pittsburg, Kansas, Verenigde Staten, 66762
        • Mercy Hospital Pittsburg
      • Topeka, Kansas, Verenigde Staten, 66606
        • Cotton O'Neil Cancer Center / Stormont Vail Health
      • Wichita, Kansas, Verenigde Staten, 67214
        • Ascension Via Christi Hospitals Wichita
      • Wichita, Kansas, Verenigde Staten, 67208
        • Associates In Womens Health
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40536
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, Verenigde Staten, 40202
        • Norton Hospital Pavilion and Medical Campus
      • Louisville, Kentucky, Verenigde Staten, 40241
        • Norton Brownsboro Hospital and Medical Campus
      • Louisville, Kentucky, Verenigde Staten, 40207
        • Norton Suburban Hospital and Medical Campus
    • Louisiana
      • Baton Rouge, Louisiana, Verenigde Staten, 70809
        • Mary Bird Perkins Cancer Center
      • Baton Rouge, Louisiana, Verenigde Staten, 70817
        • Woman's Hospital
      • Covington, Louisiana, Verenigde Staten, 70433
        • Women's Cancer Care-Covington
      • New Orleans, Louisiana, Verenigde Staten, 70121
        • Ochsner Medical Center Jefferson
    • Maine
      • Bangor, Maine, Verenigde Staten, 04401
        • Eastern Maine Medical Center
      • Brewer, Maine, Verenigde Staten, 04412
        • Lafayette Family Cancer Center-EMMC
      • Scarborough, Maine, Verenigde Staten, 04074
        • MaineHealth Maine Medical Center- Scarborough
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21237
        • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
      • Baltimore, Maryland, Verenigde Staten, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Baltimore, Maryland, Verenigde Staten, 21204
        • Greater Baltimore Medical Center
      • Easton, Maryland, Verenigde Staten, 21601
        • University of Maryland Shore Medical Center at Easton
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Verenigde Staten, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Verenigde Staten, 02111
        • Tufts Medical Center
      • Burlington, Massachusetts, Verenigde Staten, 01805
        • Lahey Clinic
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • University of Michigan Rogel Cancer Center
      • Ann Arbor, Michigan, Verenigde Staten, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Brownstown, Michigan, Verenigde Staten, 48183
        • Henry Ford Cancer Institute-Downriver
      • Clinton Township, Michigan, Verenigde Staten, 48038
        • Henry Ford Macomb Hospital-Clinton Township
      • Detroit, Michigan, Verenigde Staten, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Verenigde Staten, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Escanaba, Michigan, Verenigde Staten, 49829
        • OSF Saint Francis Hospital and Medical Group
      • Farmington Hills, Michigan, Verenigde Staten, 48334
        • Weisberg Cancer Treatment Center
      • Flint, Michigan, Verenigde Staten, 48503
        • Hurley Medical Center
      • Flint, Michigan, Verenigde Staten, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, Verenigde Staten, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Kalamazoo, Michigan, Verenigde Staten, 49007
        • West Michigan Cancer Center
      • Lansing, Michigan, Verenigde Staten, 48912
        • University of Michigan Health - Sparrow Lansing
      • Manistique, Michigan, Verenigde Staten, 49854
        • Schoolcraft Memorial Hospital
      • Pontiac, Michigan, Verenigde Staten, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
      • Southfield, Michigan, Verenigde Staten, 48075
        • Henry Ford Health Providence Southfield Hospital
      • Traverse City, Michigan, Verenigde Staten, 49684
        • Munson Medical Center
      • West Bloomfield, Michigan, Verenigde Staten, 48322
        • Henry Ford West Bloomfield Hospital
    • Minnesota
      • Bemidji, Minnesota, Verenigde Staten, 56601
        • Sanford Joe Lueken Cancer Center
      • Burnsville, Minnesota, Verenigde Staten, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Verenigde Staten, 55433
        • Mercy Hospital
      • Edina, Minnesota, Verenigde Staten, 55435
        • Fairview Southdale Hospital
      • Mankato, Minnesota, Verenigde Staten, 56001
        • Mayo Clinic Health Systems-Mankato
      • Maple Grove, Minnesota, Verenigde Staten, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, Verenigde Staten, 55109
        • Saint John's Hospital - Healtheast
      • Minneapolis, Minnesota, Verenigde Staten, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, Verenigde Staten, 55455
        • University of Minnesota/Masonic Cancer Center
      • Rochester, Minnesota, Verenigde Staten, 55905
        • Mayo Clinic in Rochester
      • Saint Louis Park, Minnesota, Verenigde Staten, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, Verenigde Staten, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Verenigde Staten, 55102
        • United Hospital
      • Shakopee, Minnesota, Verenigde Staten, 55379
        • Saint Francis Regional Medical Center
      • Woodbury, Minnesota, Verenigde Staten, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Mississippi
      • Jackson, Mississippi, Verenigde Staten, 39216
        • University of Mississippi Medical Center
      • Jackson, Mississippi, Verenigde Staten, 39216
        • Saint Dominic-Jackson Memorial Hospital
    • Missouri
      • Cape Girardeau, Missouri, Verenigde Staten, 63703
        • Saint Francis Medical Center
      • Joplin, Missouri, Verenigde Staten, 64804
        • Mercy Hospital Joplin
      • Springfield, Missouri, Verenigde Staten, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Verenigde Staten, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Verenigde Staten, 63110
        • Barnes-Jewish Hospital
      • St Louis, Missouri, Verenigde Staten, 63110
        • Washington University School of Medicine
    • Montana
      • Billings, Montana, Verenigde Staten, 59101
        • Billings Clinic Cancer Center
      • Great Falls, Montana, Verenigde Staten, 59405
        • Benefis Sletten Cancer Institute
      • Kalispell, Montana, Verenigde Staten, 59901
        • Logan Health Medical Center
      • Missoula, Montana, Verenigde Staten, 59804
        • Community Medical Center
    • Nebraska
      • Grand Island, Nebraska, Verenigde Staten, 68803
        • Nebraska Cancer Specialists/Oncology Hematology West PC
      • Kearney, Nebraska, Verenigde Staten, 68847
        • CHI Health Good Samaritan
      • Omaha, Nebraska, Verenigde Staten, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, Verenigde Staten, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, Verenigde Staten, 68130
        • Alegent Health Lakeside Hospital
    • Nevada
      • Las Vegas, Nevada, Verenigde Staten, 89106
        • Women's Cancer Center of Nevada
    • New Hampshire
      • Dover, New Hampshire, Verenigde Staten, 03820
        • Wentworth-Douglass Hospital
      • Lebanon, New Hampshire, Verenigde Staten, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
      • Nashua, New Hampshire, Verenigde Staten, 03063
        • Dartmouth Cancer Center - Nashua
    • New Jersey
      • Basking Ridge, New Jersey, Verenigde Staten, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Camden, New Jersey, Verenigde Staten, 08103
        • Cooper Hospital University Medical Center
      • Englewood, New Jersey, Verenigde Staten, 07631
        • Englewood Hospital and Medical Center
      • Voorhees Township, New Jersey, Verenigde Staten, 08043
        • MD Anderson Cancer Center at Cooper-Voorhees
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87106
        • Southwest Gynecologic Oncology Associates Inc
      • Albuquerque, New Mexico, Verenigde Staten, 87106
        • University of New Mexico Cancer Center
      • Las Cruces, New Mexico, Verenigde Staten, 88011
        • Memorial Medical Center-Las Cruces
    • New York
      • Brooklyn, New York, Verenigde Staten, 11203
        • State University of New York Downstate Medical Center
      • Buffalo, New York, Verenigde Staten, 14263
        • Roswell Park Cancer Institute
      • Commack, New York, Verenigde Staten, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, Verenigde Staten, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, Verenigde Staten, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Verenigde Staten, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Rochester, New York, Verenigde Staten, 14642
        • University of Rochester
      • The Bronx, New York, Verenigde Staten, 10461
        • Montefiore Medical Center-Einstein Campus
      • Uniondale, New York, Verenigde Staten, 11553
        • Memorial Sloan Kettering Nassau
      • White Plains, New York, Verenigde Staten, 10601
        • Dickstein Cancer Treatment Center
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Durham, North Carolina, Verenigde Staten, 27710
        • Duke University Medical Center
      • Goldsboro, North Carolina, Verenigde Staten, 27534
        • Southeastern Medical Oncology Center-Goldsboro
      • Jacksonville, North Carolina, Verenigde Staten, 28546
        • Southeastern Medical Oncology Center-Jacksonville
      • Pinehurst, North Carolina, Verenigde Staten, 28374
        • FirstHealth of the Carolinas-Moore Regional Hospital
      • Raleigh, North Carolina, Verenigde Staten, 27609
        • Duke Cancer Center Raleigh
      • Wilmington, North Carolina, Verenigde Staten, 28401
        • Novant Health New Hanover Regional Medical Center
      • Winston-Salem, North Carolina, Verenigde Staten, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Bismarck, North Dakota, Verenigde Staten, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, Verenigde Staten, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, Verenigde Staten, 58122
        • Sanford Broadway Medical Center
      • Minot, North Dakota, Verenigde Staten, 58701
        • Trinity Cancer Care Center
    • Ohio
      • Akron, Ohio, Verenigde Staten, 44307
        • Cleveland Clinic Akron General
      • Akron, Ohio, Verenigde Staten, 44304
        • Summa Health System - Akron Campus
      • Beachwood, Ohio, Verenigde Staten, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Cincinnati, Ohio, Verenigde Staten, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cincinnati, Ohio, Verenigde Staten, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, Verenigde Staten, 45247
        • TriHealth Cancer Institute-Westside
      • Cleveland, Ohio, Verenigde Staten, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Verenigde Staten, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, Verenigde Staten, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Verenigde Staten, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, Verenigde Staten, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Verenigde Staten, 43210
        • Ohio State University Comprehensive Cancer Center
      • Columbus, Ohio, Verenigde Staten, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, Verenigde Staten, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Dayton, Ohio, Verenigde Staten, 45405
        • Grandview Hospital
      • Findlay, Ohio, Verenigde Staten, 45840
        • Orion Cancer Care
      • Mayfield Heights, Ohio, Verenigde Staten, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, Verenigde Staten, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
      • Sylvania, Ohio, Verenigde Staten, 43560
        • ProMedica Flower Hospital
      • Toledo, Ohio, Verenigde Staten, 43606
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
      • Wadsworth, Ohio, Verenigde Staten, 44281
        • University Hospitals Sharon Health Center
      • Westlake, Ohio, Verenigde Staten, 44145
        • UHHS-Westlake Medical Center
      • Wright-Patterson Air Force Base, Ohio, Verenigde Staten, 45433
        • Wright-Patterson Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, Verenigde Staten, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Oregon
      • Bend, Oregon, Verenigde Staten, 97701
        • Saint Charles Health System
      • Eugene, Oregon, Verenigde Staten, 97401
        • Willamette Valley Cancer Center
      • Gresham, Oregon, Verenigde Staten, 97030
        • Legacy Mount Hood Medical Center
      • Portland, Oregon, Verenigde Staten, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, Verenigde Staten, 97227
        • Kaiser Permanente Northwest
      • Tualatin, Oregon, Verenigde Staten, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Abington, Pennsylvania, Verenigde Staten, 19001
        • Jefferson Abington Hospital
      • Bethlehem, Pennsylvania, Verenigde Staten, 18015
        • Saint Luke's University Hospital-Bethlehem Campus
      • Danville, Pennsylvania, Verenigde Staten, 17822
        • Geisinger Medical Center
      • Ephrata, Pennsylvania, Verenigde Staten, 17522
        • Ephrata Cancer Center
      • Gettysburg, Pennsylvania, Verenigde Staten, 17325
        • Adams Cancer Center
      • Lancaster, Pennsylvania, Verenigde Staten, 17602
        • Lancaster General Hospital
      • Philadelphia, Pennsylvania, Verenigde Staten, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • University of Pennsylvania/Abramson Cancer Center
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15224
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15232
        • UPMC Hillman Cancer Center
      • Sayre, Pennsylvania, Verenigde Staten, 18840
        • Guthrie Medical Group PC-Robert Packer Hospital
      • Selinsgrove, Pennsylvania, Verenigde Staten, 17870
        • Geisinger Medical Oncology-Selinsgrove
      • West Reading, Pennsylvania, Verenigde Staten, 19611
        • Reading Hospital
      • Williamsport, Pennsylvania, Verenigde Staten, 17701
        • UPMC Susquehanna
      • York, Pennsylvania, Verenigde Staten, 17403
        • WellSpan Health-York Hospital
    • Rhode Island
      • Providence, Rhode Island, Verenigde Staten, 02905
        • Women and Infants Hospital
    • South Carolina
      • Anderson, South Carolina, Verenigde Staten, 29621
        • AnMed Health Cancer Center
      • Charleston, South Carolina, Verenigde Staten, 29425
        • Medical University of South Carolina
      • Gaffney, South Carolina, Verenigde Staten, 29341
        • Gibbs Cancer Center-Gaffney
      • Greenville, South Carolina, Verenigde Staten, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, Verenigde Staten, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, Verenigde Staten, 29601
        • Saint Francis Hospital
      • Greer, South Carolina, Verenigde Staten, 29651
        • Gibbs Cancer Center-Pelham
      • Hilton Head Island, South Carolina, Verenigde Staten, 29926-3827
        • South Carolina Cancer Specialists PC
      • Spartanburg, South Carolina, Verenigde Staten, 29303
        • Spartanburg Medical Center
      • Union, South Carolina, Verenigde Staten, 29379
        • SMC Center for Hematology Oncology Union
    • South Dakota
      • Rapid City, South Dakota, Verenigde Staten, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Verenigde Staten, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Verenigde Staten, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, Verenigde Staten, 57104
        • Sanford Cancer Center Oncology Clinic
    • Tennessee
      • Johnson City, Tennessee, Verenigde Staten, 37604
        • Wellmont Medical Associates Oncology and Hematology-Johnson City
      • Kingsport, Tennessee, Verenigde Staten, 37660
        • Ballad Health Cancer Care - Kingsport
      • Kingsport, Tennessee, Verenigde Staten, 37660
        • Wellmont Holston Valley Hospital and Medical Center
      • Knoxville, Tennessee, Verenigde Staten, 37916
        • Covenant Health Cancer Centers
      • Knoxville, Tennessee, Verenigde Staten, 37932
        • Covenant Health Cancer Centers - West
      • Nashville, Tennessee, Verenigde Staten, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Austin, Texas, Verenigde Staten, 78731
        • Texas Oncology - Central Austin Cancer Center
      • Austin, Texas, Verenigde Staten, 78745
        • Texas Oncology - South Austin Cancer Center
      • Bedford, Texas, Verenigde Staten, 76022
        • Texas Oncology Bedford
      • Dallas, Texas, Verenigde Staten, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, Verenigde Staten, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Fort Worth, Texas, Verenigde Staten, 76104
        • Texas Oncology - Fort Worth Cancer Center
      • Houston, Texas, Verenigde Staten, 77030
        • Houston Methodist Hospital
      • Houston, Texas, Verenigde Staten, 77070
        • Methodist Willowbrook Hospital
      • Sugar Land, Texas, Verenigde Staten, 77479
        • Houston Methodist Sugar Land Hospital
      • The Woodlands, Texas, Verenigde Staten, 77380
        • Texas Oncology-The Woodlands
    • Utah
      • Murray, Utah, Verenigde Staten, 84107
        • Intermountain Medical Center
      • Salt Lake City, Utah, Verenigde Staten, 84106
        • Utah Cancer Specialists-Salt Lake City
      • St. George, Utah, Verenigde Staten, 84770
        • Saint George Regional Medical Center
    • Virginia
      • Charlottesville, Virginia, Verenigde Staten, 22908
        • University of Virginia Cancer Center
      • Richmond, Virginia, Verenigde Staten, 23298
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Kennewick, Washington, Verenigde Staten, 99336
        • Kadlec Clinic Hematology and Oncology
      • Mount Vernon, Washington, Verenigde Staten, 98274
        • Skagit Valley Hospital
      • Mount Vernon, Washington, Verenigde Staten, 98274
        • Skagit Regional Health Cancer Care Center
      • Seattle, Washington, Verenigde Staten, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, Verenigde Staten, 98195
        • University of Washington Medical Center - Montlake
      • Seattle, Washington, Verenigde Staten, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, Verenigde Staten, 98109
        • Fred Hutchinson Cancer Center
      • Seattle, Washington, Verenigde Staten, 98133
        • University of Washington Medical Center - Northwest
      • Seattle, Washington, Verenigde Staten, 98133
        • Women's Cancer Center of Seattle
      • Vancouver, Washington, Verenigde Staten, 98686
        • Legacy Salmon Creek Hospital
      • Wenatchee, Washington, Verenigde Staten, 98801
        • Wenatchee Valley Hospital and Clinics
    • West Virginia
      • Charleston, West Virginia, Verenigde Staten, 25304
        • Vandalia Health/CAMC Institute for Academic Medicine
      • Huntington, West Virginia, Verenigde Staten, 25701
        • Edwards Comprehensive Cancer Center
    • Wisconsin
      • Chippewa Falls, Wisconsin, Verenigde Staten, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, Verenigde Staten, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Green Bay, Wisconsin, Verenigde Staten, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, Verenigde Staten, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • La Crosse, Wisconsin, Verenigde Staten, 54601
        • Gundersen Lutheran Medical Center
      • Ladysmith, Wisconsin, Verenigde Staten, 54848
        • Marshfield Medical Center - Ladysmith
      • Madison, Wisconsin, Verenigde Staten, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Marinette, Wisconsin, Verenigde Staten, 54143
        • Saint Vincent Hospital Cancer Center at Marinette
      • Marshfield, Wisconsin, Verenigde Staten, 54449
        • Marshfield Medical Center-Marshfield
      • Milwaukee, Wisconsin, Verenigde Staten, 53226
        • Medical College of Wisconsin
      • Minocqua, Wisconsin, Verenigde Staten, 54548
        • Marshfield Medical Center - Minocqua
      • Mukwonago, Wisconsin, Verenigde Staten, 53149
        • ProHealth D N Greenwald Center
      • Oconomowoc, Wisconsin, Verenigde Staten, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oconto Falls, Wisconsin, Verenigde Staten, 54154
        • Saint Vincent Hospital Cancer Center at Oconto Falls
      • Rice Lake, Wisconsin, Verenigde Staten, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, Verenigde Staten, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Stevens Point, Wisconsin, Verenigde Staten, 54481
        • Aspirus Cancer Care - Stevens Point
      • Sturgeon Bay, Wisconsin, Verenigde Staten, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Waukesha, Wisconsin, Verenigde Staten, 53188
        • UW Cancer Center at ProHealth Care
      • Waukesha, Wisconsin, Verenigde Staten, 53188
        • ProHealth Waukesha Memorial Hospital
      • Wausau, Wisconsin, Verenigde Staten, 54401
        • Marshfield Clinic-Wausau Center
      • Weston, Wisconsin, Verenigde Staten, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, Verenigde Staten, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
  • Zuid -Korea
      • Seoul, Zuid -Korea, 110-744
        • Seoul National University Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of starting treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients may not have had hormonal therapy within 2 weeks prior to entering the study; patients receiving raloxifene for bone health as per Food and Drug Administration (FDA) indication may remain on raloxifene absent other drug interactions

  • Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks

  • Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine)

  • Patients may not have received prior treatment affecting the vascular endothelial growth factor (VEGF) pathway (including, but not limited to thalidomide, sunitinib, pazopanib, sorafenib, and nintedanib); bevacizumab used in the upfront setting in conjunction with chemotherapy and/or as maintenance to treat newly diagnosed disease will be allowed

  • Patients may not have previously received a PARP inhibitor

  • CA-125 only disease without RECIST 1.1 measurable or otherwise evaluable disease

  • Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on CT or MRI scans should not be included on this study, since neurologic dysfunction may confound the evaluation of neurologic and other adverse events; screening imaging to rule out brain metastases is not required for screening, but should be performed prior to study enrollment if clinically indicated; patients with treated brain metastases and resolution of any associated symptoms must demonstrate stable post-therapeutic imaging for at least 6 months following therapy prior to starting study drug

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib

  • Participants receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; strong inhibitors and inducers of UGT/PgP should be used with caution

  • History of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula

  • History of intra-abdominal abscess within the past 3 months

  • Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs

  • Dependency on intravenous (IV) hydration or total parenteral nutrition (TPN)

  • Any concomitant or prior invasive malignancies with the following curatively treated exceptions:

    • Treated limited stage basal cell or squamous cell carcinoma of the skin
    • Carcinoma in situ of the breast or cervix
    • Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous/serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions
    • Prior cancer treated with a curative intent with no evidence of recurrent disease 3 years following diagnosis and judged by the investigator to be at low risk of recurrence

  • Patients with any of the following:

    • History of myocardial infarction within six months
    • Unstable angina
    • Resting electrocardiogram (ECG) with clinically significant abnormal findings
    • New York Heart Association (NYHA) classification of III or IV

  • If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines

    • Patients with the following risk factors should have a baseline cardiac function assessment:

      • Prior treatment with anthracyclines
      • Prior treatment with trastuzumab
      • Prior central thoracic radiation therapy (RT), including RT to the heart
      • History of myocardial infarction within 6 to 12 months (patients with history of myocardial infarction within 6 months are excluded from the study)
      • Prior history of impaired cardiac function

  • History of stroke or transient ischemic attack within six months

  • Any prior history of hypertensive crisis or hypertensive encephalopathy

  • Clinically significant peripheral vascular disease or vascular disease (including aortic aneurysm or aortic dissection)

  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib

  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (other than atrial fibrillation with controlled ventricular rate), or psychiatric illness/social situations that would limit compliance with study requirements

  • Pregnant women are excluded from this study because cediranib and olaparib are agents with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with cediranib and olaparib, breastfeeding should be discontinued if the mother is treated with cediranib or olaparib; these potential risks may also apply to other agents used in this study

  • Known HIV-positive individuals are ineligible because of the potential for pharmacokinetic interactions with cediranib or olaparib; in addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy

  • Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies as they may interfere with the effectiveness of the study treatments

  • No features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated

  • No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Arm I (platinum-based chemotherapy)

See detailed description.
Geneesmiddel: Carboplatin

Given IV

Andere namen:
  • Blastocarb
  • Carboplat
  • Carboplatine Hexal
  • Carboplatino
  • Carboplatina
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatina
  • Paraplatine
  • Paraplatina AQ
  • Platinawas
  • Ribocarbo
  • JM8
Geneesmiddel: Paclitaxel

Given IV

Andere namen:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Ander: Laboratory Biomarker Analysis

Correlative studies

Ander: Quality-of-Life Assessment

Ancillary studies

Andere namen:
  • Beoordeling van de kwaliteit van leven
Procedure: Computed Tomography

Undergo CT

Andere namen:
  • CT
  • KAT
  • CT-scan
  • Axiale computertomografie
  • Computergestuurde axiale tomografie
  • Computergestuurde tomografie
  • tomografie
  • Geautomatiseerde axiale tomografie (procedure)
  • Computertomografie (CT)-scan
  • Diagnostische kattencan
  • Diagnostisch CAT -scanservice type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:
  • MRI
  • Magnetische resonantie
  • Magnetic Resonance Imaging-scan
  • Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie
  • DHR
  • MR-beeldvorming
  • MRI scan
  • NMR-beeldvorming
  • NMRI
  • Nucleaire magnetische resonantie beeldvorming
  • Magnetische resonantiebeeldvorming (MRI)
  • sMRI
  • Magnetische resonantiebeeldvorming (procedure)
  • MRI's
  • Structurele MRI
Procedure: Echocardiography Test

Undergo ECHO

Andere namen:
  • Echocardiografie
  • EG
Procedure: Multigated Acquisition Scan

Undergo MUGA

Andere namen:
  • Blood Pool-scan
  • Equilibrium radionuclide angiografie
  • Gated Blood Pool-beeldvorming
  • MUGA
  • Radionuclide ventriculografie
  • RNVG
  • SYMA scannen
  • Gesynchroniseerde Multigated Acquisitie Scannen
  • MUGA-scan
  • Multi-Gated Acquisitie Scan
  • Radionuclide ventriculogram scan
  • Gated Heart Pool-scan
  • RNV-scan
Geneesmiddel: Gemcitabine Hydrochloride

Given IV

Andere namen:
  • Gemzar
  • dFdCyd
  • Difluordeoxycytidine hydrochloride
  • Gemcitabine HCI
  • LY-188011
  • LY188011
  • LY 188011
Geneesmiddel: Gemcitabine

Given IV

Andere namen:
  • dFdCyd
  • dFdC
  • Difluordeoxycytidine
Geneesmiddel: Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

Andere namen:
  • ATI-0918
  • Caelyx
  • Doxil
  • Doxilen
  • Doxorubicine HCl Liposoom
  • Duomeisu
  • Ontruimen
  • LipoDox
  • Liposomale adriamycine
  • Liposomaal ingekapselde doxorubicine
  • Gepegyleerd Doxorubicine HCl Liposoom
  • S-liposomale doxorubicine
  • Stealth liposomale doxorubicine
  • TLC-D-99
  • Dox-SL
  • Doxorubicine HCl Liposomaal
  • Doxorubicine hydrochloride liposoom
  • Lipodox 50
  • Liposomaal doxorubicinehydrochloride
  • Gepegyleerde liposomale doxorubicine
  • Doxorubicine Liposomaal
Experimenteel: Arm II (olaparib)

Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
Ander: Laboratory Biomarker Analysis

Correlative studies

Ander: Quality-of-Life Assessment

Ancillary studies

Andere namen:
  • Beoordeling van de kwaliteit van leven
Procedure: Biospecimen Collection

Undergo blood sample collection

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling
Procedure: Computed Tomography

Undergo CT

Andere namen:
  • CT
  • KAT
  • CT-scan
  • Axiale computertomografie
  • Computergestuurde axiale tomografie
  • Computergestuurde tomografie
  • tomografie
  • Geautomatiseerde axiale tomografie (procedure)
  • Computertomografie (CT)-scan
  • Diagnostische kattencan
  • Diagnostisch CAT -scanservice type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:
  • MRI
  • Magnetische resonantie
  • Magnetic Resonance Imaging-scan
  • Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie
  • DHR
  • MR-beeldvorming
  • MRI scan
  • NMR-beeldvorming
  • NMRI
  • Nucleaire magnetische resonantie beeldvorming
  • Magnetische resonantiebeeldvorming (MRI)
  • sMRI
  • Magnetische resonantiebeeldvorming (procedure)
  • MRI's
  • Structurele MRI
Procedure: Echocardiography Test

Undergo ECHO

Andere namen:
  • Echocardiografie
  • EG
Procedure: Multigated Acquisition Scan

Undergo MUGA

Andere namen:
  • Blood Pool-scan
  • Equilibrium radionuclide angiografie
  • Gated Blood Pool-beeldvorming
  • MUGA
  • Radionuclide ventriculografie
  • RNVG
  • SYMA scannen
  • Gesynchroniseerde Multigated Acquisitie Scannen
  • MUGA-scan
  • Multi-Gated Acquisitie Scan
  • Radionuclide ventriculogram scan
  • Gated Heart Pool-scan
  • RNV-scan
Ander: Pharmacological Study

Correlative studies

Geneesmiddel: Olaparib

Given PO

Andere namen:
  • Lynparza
  • AZD 2281
  • AZD-2281
  • AZD2281
  • KU-0059436
  • PARP-remmer AZD2281
  • KU0059436
  • Olanib
  • Olaparix
Experimenteel: 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. Patients undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo CT or MRI as well as blood sample collection throughout the trial.
Ander: Laboratory Biomarker Analysis

Correlative studies

Ander: Quality-of-Life Assessment

Ancillary studies

Andere namen:
  • Beoordeling van de kwaliteit van leven
Procedure: Biospecimen Collection

Undergo blood sample collection

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling
Procedure: Computed Tomography

Undergo CT

Andere namen:
  • CT
  • KAT
  • CT-scan
  • Axiale computertomografie
  • Computergestuurde axiale tomografie
  • Computergestuurde tomografie
  • tomografie
  • Geautomatiseerde axiale tomografie (procedure)
  • Computertomografie (CT)-scan
  • Diagnostische kattencan
  • Diagnostisch CAT -scanservice type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:
  • MRI
  • Magnetische resonantie
  • Magnetic Resonance Imaging-scan
  • Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie
  • DHR
  • MR-beeldvorming
  • MRI scan
  • NMR-beeldvorming
  • NMRI
  • Nucleaire magnetische resonantie beeldvorming
  • Magnetische resonantiebeeldvorming (MRI)
  • sMRI
  • Magnetische resonantiebeeldvorming (procedure)
  • MRI's
  • Structurele MRI
Procedure: Echocardiography Test

Undergo ECHO

Andere namen:
  • Echocardiografie
  • EG
Procedure: Multigated Acquisition Scan

Undergo MUGA

Andere namen:
  • Blood Pool-scan
  • Equilibrium radionuclide angiografie
  • Gated Blood Pool-beeldvorming
  • MUGA
  • Radionuclide ventriculografie
  • RNVG
  • SYMA scannen
  • Gesynchroniseerde Multigated Acquisitie Scannen
  • MUGA-scan
  • Multi-Gated Acquisitie Scan
  • Radionuclide ventriculogram scan
  • Gated Heart Pool-scan
  • RNV-scan
Ander: Pharmacological Study

Correlative studies

Geneesmiddel: Cediranib Maleate

Given PO

Andere namen:
  • AZD2171
  • AZD2171 Maleaat
  • Recentin
Geneesmiddel: Olaparib

Given PO

Andere namen:
  • Lynparza
  • AZD 2281
  • AZD-2281
  • AZD2281
  • KU-0059436
  • PARP-remmer AZD2281
  • KU0059436
  • Olanib
  • Olaparix

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria
Tijdsspanne: The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.

Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments. Japanese cohort not included in progression free survival analysis, only included in toxicity assessments.
The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival
Tijdsspanne: Approximately 30 months

Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last follow-up were censored on the date of last contact. Japanese cohort not included in overall survival analysis, the cohort was only included in toxicity assessments.
Approximately 30 months
Frequency and Severity of Adverse Effects
Tijdsspanne: During treatment period and up to 100 days after stopping the study treatment, up to 39 months.

Number of treated patients with Adverse Events (grade 3 or higher) observed while receiving randomized therapy, by Preferred term with incidence rate greater than 5%.
During treatment period and up to 100 days after stopping the study treatment, up to 39 months.
Patient Reported Scores of Disease-related Symptoms as Measured by the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 Disease-Related Symptom-Physical
Tijdsspanne: Prior to cycle 1, week 12, week 24, week 36, week 48, week 60, week 72, week 84, week 96 and 108 weeks after starting treatment

Disease-related physical symptoms were measured by the Disease-Related Symptom-Physical (DRS-P) subscale of the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NCCN/FOSI-18). The DRS-P subscale is composed of 9 items. For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The DRS-P score ranges 0-36 with a larger score suggesting better QOL (Quality of Life) or less symptoms. This analysis did not include the Japanese cohort.
Prior to cycle 1, week 12, week 24, week 36, week 48, week 60, week 72, week 84, week 96 and 108 weeks after starting treatment

Andere uitkomstmaten

Uitkomstmaat
Tijdsspanne
Tijd vanaf randomisatie tot de eerste niet-studie, antikankerbehandeling of overlijden
Tijdsspanne: Tot 5 jaar
Tot 5 jaar
Tijd vanaf randomisatie tot de tweede niet-studie, behandeling tegen kanker of overlijden
Tijdsspanne: Tot 5 jaar
Tot 5 jaar

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Cancer Institute (NCI)

Medewerkers

AstraZeneca
NRG Oncology

Onderzoekers

  • Hoofdonderzoeker: Joyce F Liu, NRG Oncology

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 maart 2016

Primaire voltooiing (Werkelijk)

23 februari 2020

Studie voltooiing (Geschat)

4 maart 2027

Studieregistratiedata

Eerst ingediend

11 mei 2015

Eerst ingediend dat voldeed aan de QC-criteria

13 mei 2015

Eerst geplaatst (Geschat)

18 mei 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

30 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NCI-2015-00606
  • U10CA180868 (Subsidie/contract van de Amerikaanse NIH)
  • NCI-2015-00606 (Register-ID: CTRP (Clinical Trial Reporting Program))
  • s16-01480
  • NRG-GY004 (Andere identificatie: CTEP)
  • NRG-GY004
  • NRG-GY004 (Andere identificatie: NRG Oncology)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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