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Testando o uso de um único medicamento (olaparibe) ou a combinação de dois medicamentos (cediranibe e olaparibe) em comparação com a quimioterapia usual para mulheres com câncer de ovário sensível à platina, trompa de falópio ou câncer peritoneal primário

30 de setembro de 2026 atualizado por: National Cancer Institute (NCI)

Um estudo de fase III comparando o agente único de olaparibe ou a combinação de cediranibe e olaparibe com a quimioterapia padrão baseada em platina em mulheres com câncer recorrente de ovário sensível à platina, trompas de falópio ou peritoneal primário

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.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

579

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Arm I (platinum-based chemotherapy)

See detailed description.
Medicamento: Carboplatin

Given IV

Outros nomes:
  • Blastocarbe
  • Carboplat
  • Carboplatina Hexal
  • Carboplatina
  • Carbosina
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatina
  • Paraplatina
  • Paraplatina AQ
  • Platinwas
  • Ribocarbo
  • JM8
Medicamento: Paclitaxel

Given IV

Outros nomes:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Outro: Laboratory Biomarker Analysis

Correlative studies

Outro: Quality-of-Life Assessment

Ancillary studies

Outros nomes:
  • Avaliação da Qualidade de Vida
Procedimento: Computed Tomography

Undergo CT

Outros nomes:
  • TC
  • GATO
  • Tomografia
  • Tomografia Axial Computadorizada
  • Tomografia computadorizada
  • tomografia
  • Tomografia axial computadorizada (procedimento)
  • Tomografia computadorizada (TC)
  • Diagnóstico Cat Scan
  • Tipo de serviço de varredura de gato diagnóstico
Procedimento: Magnetic Resonance Imaging

Undergo MRI

Outros nomes:
  • Ressonância magnética
  • Varredura de imagem por ressonância magnética
  • Imagem Médica, Ressonância Magnética / Ressonância Magnética Nuclear
  • SENHOR
  • Exame de ressonância magnética
  • Imagem NMR
  • Ressonância Magnética Nuclear
  • Ressonância Magnética (MRI)
  • ressonância magnética
  • Ressonância magnética (procedimento)
  • Ressonâncias magnéticas
  • RM estrutural
Procedimento: Echocardiography Test

Undergo ECHO

Outros nomes:
  • Ecocardiografia
  • CE
Procedimento: Multigated Acquisition Scan

Undergo MUGA

Outros nomes:
  • Varredura de sangue
  • Angiografia com Radionuclídeos de Equilíbrio
  • Imagem de pool de sangue fechado
  • MUGA
  • Ventriculografia com radionuclídeo
  • RNVG
  • Digitalização SIMA
  • Varredura de Aquisição Multigatada Sincronizada
  • Varredura MUGA
  • Varredura de Aquisição Multi-Gated
  • Varredura de ventriculograma com radionuclídeo
  • Varredura de pool de coração fechado
  • Varredura RNV
Medicamento: Gemcitabine Hydrochloride

Given IV

Outros nomes:
  • Gemzar
  • dFdCyd
  • Cloridrato de Difluorodesoxicitidina
  • Gemcitabina HCI
  • LY-188011
  • LY188011
  • LY 188011
Medicamento: Gemcitabine

Given IV

Outros nomes:
  • dFdCyd
  • dFdC
  • Difluorodesoxicitidina
Medicamento: Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

Outros nomes:
  • ATI-0918
  • Caelyx
  • Doxil
  • Doxilen
  • Doxorrubicina HCl Lipossoma
  • Duomeisu
  • Evacet
  • LipoDox
  • Adriamicina Lipossomal
  • Doxorrubicina encapsulada em lipossomas
  • Lipossoma Peguilado de Doxorrubicina HCl
  • Doxorrubicina S-Lipossômica
  • Doxorrubicina Lipossomal Stealth
  • TLC D-99
  • Dox-SL
  • Doxorrubicina HCl Lipossomal
  • Lipossoma de Cloridrato de Doxorrubicina
  • Lipodox 50
  • Cloridrato de Doxorrubicina Lipossomal
  • Doxorrubicina Lipossomal Peguilada
  • Doxorrubicina Lipossomal
Experimental: 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.
Outro: Laboratory Biomarker Analysis

Correlative studies

Outro: Quality-of-Life Assessment

Ancillary studies

Outros nomes:
  • Avaliação da Qualidade de Vida
Procedimento: Biospecimen Collection

Undergo blood sample collection

Outros nomes:
  • Coleta de Amostras Biológicas
  • Bioespécime coletado
  • Coleta de amostras
Procedimento: Computed Tomography

Undergo CT

Outros nomes:
  • TC
  • GATO
  • Tomografia
  • Tomografia Axial Computadorizada
  • Tomografia computadorizada
  • tomografia
  • Tomografia axial computadorizada (procedimento)
  • Tomografia computadorizada (TC)
  • Diagnóstico Cat Scan
  • Tipo de serviço de varredura de gato diagnóstico
Procedimento: Magnetic Resonance Imaging

Undergo MRI

Outros nomes:
  • Ressonância magnética
  • Varredura de imagem por ressonância magnética
  • Imagem Médica, Ressonância Magnética / Ressonância Magnética Nuclear
  • SENHOR
  • Exame de ressonância magnética
  • Imagem NMR
  • Ressonância Magnética Nuclear
  • Ressonância Magnética (MRI)
  • ressonância magnética
  • Ressonância magnética (procedimento)
  • Ressonâncias magnéticas
  • RM estrutural
Procedimento: Echocardiography Test

Undergo ECHO

Outros nomes:
  • Ecocardiografia
  • CE
Procedimento: Multigated Acquisition Scan

Undergo MUGA

Outros nomes:
  • Varredura de sangue
  • Angiografia com Radionuclídeos de Equilíbrio
  • Imagem de pool de sangue fechado
  • MUGA
  • Ventriculografia com radionuclídeo
  • RNVG
  • Digitalização SIMA
  • Varredura de Aquisição Multigatada Sincronizada
  • Varredura MUGA
  • Varredura de Aquisição Multi-Gated
  • Varredura de ventriculograma com radionuclídeo
  • Varredura de pool de coração fechado
  • Varredura RNV
Outro: Pharmacological Study

Correlative studies

Medicamento: Olaparib

Given PO

Outros nomes:
  • Lynparza
  • AZD 2281
  • AZD-2281
  • AZD2281
  • KU-0059436
  • Inibidor PARP AZD2281
  • KU0059436
  • Olanibe
  • Olaparix
  • KU 0059436
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. 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.
Outro: Laboratory Biomarker Analysis

Correlative studies

Outro: Quality-of-Life Assessment

Ancillary studies

Outros nomes:
  • Avaliação da Qualidade de Vida
Procedimento: Biospecimen Collection

Undergo blood sample collection

Outros nomes:
  • Coleta de Amostras Biológicas
  • Bioespécime coletado
  • Coleta de amostras
Procedimento: Computed Tomography

Undergo CT

Outros nomes:
  • TC
  • GATO
  • Tomografia
  • Tomografia Axial Computadorizada
  • Tomografia computadorizada
  • tomografia
  • Tomografia axial computadorizada (procedimento)
  • Tomografia computadorizada (TC)
  • Diagnóstico Cat Scan
  • Tipo de serviço de varredura de gato diagnóstico
Procedimento: Magnetic Resonance Imaging

Undergo MRI

Outros nomes:
  • Ressonância magnética
  • Varredura de imagem por ressonância magnética
  • Imagem Médica, Ressonância Magnética / Ressonância Magnética Nuclear
  • SENHOR
  • Exame de ressonância magnética
  • Imagem NMR
  • Ressonância Magnética Nuclear
  • Ressonância Magnética (MRI)
  • ressonância magnética
  • Ressonância magnética (procedimento)
  • Ressonâncias magnéticas
  • RM estrutural
Procedimento: Echocardiography Test

Undergo ECHO

Outros nomes:
  • Ecocardiografia
  • CE
Procedimento: Multigated Acquisition Scan

Undergo MUGA

Outros nomes:
  • Varredura de sangue
  • Angiografia com Radionuclídeos de Equilíbrio
  • Imagem de pool de sangue fechado
  • MUGA
  • Ventriculografia com radionuclídeo
  • RNVG
  • Digitalização SIMA
  • Varredura de Aquisição Multigatada Sincronizada
  • Varredura MUGA
  • Varredura de Aquisição Multi-Gated
  • Varredura de ventriculograma com radionuclídeo
  • Varredura de pool de coração fechado
  • Varredura RNV
Outro: Pharmacological Study

Correlative studies

Medicamento: Cediranib Maleate

Given PO

Outros nomes:
  • AZD2171
  • AZD2171 Maleato
  • Recentes
Medicamento: Olaparib

Given PO

Outros nomes:
  • Lynparza
  • AZD 2281
  • AZD-2281
  • AZD2281
  • KU-0059436
  • Inibidor PARP AZD2281
  • KU0059436
  • Olanibe
  • Olaparix
  • KU 0059436

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Survival
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Prazo
Tempo desde a randomização até o primeiro não estudo, tratamento anticancerígeno ou morte
Prazo: Até 5 anos
Até 5 anos
Tempo desde a randomização até o segundo não estudo, tratamento anticancerígeno ou morte
Prazo: Até 5 anos
Até 5 anos

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Cancer Institute (NCI)

Colaboradores

AstraZeneca
NRG Oncology

Investigadores

  • Investigador principal: Joyce F Liu, NRG Oncology

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

28 de março de 2016

Conclusão Primária (Real)

23 de fevereiro de 2020

Conclusão do estudo (Estimado)

4 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

11 de maio de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de maio de 2015

Primeira postagem (Estimado)

18 de maio de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NCI-2015-00606
  • U10CA180868 (Concessão/Contrato do NIH dos EUA)
  • NCI-2015-00606 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • s16-01480
  • NRG-GY004 (Outro identificador: CTEP)
  • NRG-GY004
  • NRG-GY004 (Outro identificador: NRG Oncology)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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