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Testing av bruken av et enkelt legemiddel (Olaparib) eller kombinasjonen av to legemidler (Cediranib og Olaparib) sammenlignet med vanlig kjemoterapi for kvinner med platinasensitiv eggstokk, eggleder eller primær peritonealkreft

30. september 2026 oppdatert av: National Cancer Institute (NCI)

En fase III-studie som sammenligner enkeltmiddel olaparib eller kombinasjonen av cediranib og olaparib med standard platinabasert kjemoterapi hos kvinner med tilbakevendende platinasensitiv ovarie-, eggleder- eller primær peritonealkreft

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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Faktiske)

579

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Arm I (platinum-based chemotherapy)

See detailed description.
Legemiddel: Carboplatin

Given IV

Andre navn:
  • Blastokarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Karboplatina
  • Karbosin
  • Karbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Platinwas
  • Ribocarbo
  • JM8
Legemiddel: Paclitaxel

Given IV

Andre navn:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Annen: Laboratory Biomarker Analysis

Correlative studies

Annen: Quality-of-Life Assessment

Ancillary studies

Andre navn:
  • Livskvalitetsvurdering
Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Echocardiography Test

Undergo ECHO

Andre navn:
  • Ekkokardiografi
  • EC
Fremgangsmåte: Multigated Acquisition Scan

Undergo MUGA

Andre navn:
  • Skanning av blodbasseng
  • Likevektsradionuklidangiografi
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid ventrikulografi
  • RNVG
  • SYMA-skanning
  • Synchronized Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid ventrikulogramskanning
  • Gated Heart Pool Scan
  • RNV Scan
Legemiddel: Gemcitabine Hydrochloride

Given IV

Andre navn:
  • Gemzar
  • dFdCyd
  • Difluordeoksycytidinhydroklorid
  • Gemcitabin HCI
  • LY-188011
  • LY188011
  • LY 188011
Legemiddel: Gemcitabine

Given IV

Andre navn:
  • dFdCyd
  • dFdC
  • Difluordeoksycytidin
Legemiddel: Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

Andre navn:
  • ATI-0918
  • Caelyx
  • Doxil
  • Doxilen
  • Doxorubicin HCl-liposomet
  • Duomeisu
  • Evacet
  • LipoDox
  • Liposomal Adriamycin
  • Liposomal-innkapslet doksorubicin
  • Pegylert doksorubicin HCl-liposomet
  • S-liposomal doksorubicin
  • Stealth Liposomal Doxorubicin
  • TLC D-99
  • Dox-SL
  • Doxorubicin HCl Liposomal
  • Doxorubicin hydrokloridliposomet
  • Lipodox 50
  • Liposomal doksorubicinhydroklorid
  • Pegylert liposomalt doksorubicin
  • Doxorubicin Liposomal
Eksperimentell: 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.
Annen: Laboratory Biomarker Analysis

Correlative studies

Annen: Quality-of-Life Assessment

Ancillary studies

Andre navn:
  • Livskvalitetsvurdering
Fremgangsmåte: Biospecimen Collection

Undergo blood sample collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Echocardiography Test

Undergo ECHO

Andre navn:
  • Ekkokardiografi
  • EC
Fremgangsmåte: Multigated Acquisition Scan

Undergo MUGA

Andre navn:
  • Skanning av blodbasseng
  • Likevektsradionuklidangiografi
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid ventrikulografi
  • RNVG
  • SYMA-skanning
  • Synchronized Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid ventrikulogramskanning
  • Gated Heart Pool Scan
  • RNV Scan
Annen: Pharmacological Study

Correlative studies

Legemiddel: Olaparib

Given PO

Andre navn:
  • Lynparza
  • AZD 2281
  • AZD-2281
  • AZD2281
  • KU-0059436
  • PARP-hemmer AZD2281
  • KU0059436
  • Olanib
  • Olaparix
  • KU 0059436
Eksperimentell: 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.
Annen: Laboratory Biomarker Analysis

Correlative studies

Annen: Quality-of-Life Assessment

Ancillary studies

Andre navn:
  • Livskvalitetsvurdering
Fremgangsmåte: Biospecimen Collection

Undergo blood sample collection

Andre navn:
  • Biologisk prøvesamling
  • Bioprøve samlet
  • Prøvesamling
Fremgangsmåte: Computed Tomography

Undergo CT

Andre navn:
  • CT
  • KATT
  • CAT-skanning
  • Beregnet aksial tomografi
  • Datastyrt aksialtomografi
  • Datastyrt tomografi
  • CT skann
  • tomografi
  • Datastyrt aksial tomografi (prosedyre)
  • Datastyrt tomografi (CT) skanning
  • Diagnostisk CAT -skanning
  • Diagnostisk CAT -skannertype
Fremgangsmåte: Magnetic Resonance Imaging

Undergo MRI

Andre navn:
  • MR
  • Magnetisk resonans
  • Magnetic Resonance Imaging Scan
  • Medisinsk bildebehandling, magnetisk resonans / kjernemagnetisk resonans
  • MR Imaging
  • MR-skanning
  • NMR-avbildning
  • NMRI
  • Kjernemagnetisk resonansavbildning
  • Magnetisk resonanstomografi (MR)
  • sMRI
  • Magnetisk resonansavbildning (prosedyre)
  • MR-er
  • Strukturell MR
Fremgangsmåte: Echocardiography Test

Undergo ECHO

Andre navn:
  • Ekkokardiografi
  • EC
Fremgangsmåte: Multigated Acquisition Scan

Undergo MUGA

Andre navn:
  • Skanning av blodbasseng
  • Likevektsradionuklidangiografi
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuklid ventrikulografi
  • RNVG
  • SYMA-skanning
  • Synchronized Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuklid ventrikulogramskanning
  • Gated Heart Pool Scan
  • RNV Scan
Annen: Pharmacological Study

Correlative studies

Legemiddel: Cediranib Maleate

Given PO

Andre navn:
  • AZD2171
  • AZD2171 maleat
  • Nylig
Legemiddel: Olaparib

Given PO

Andre navn:
  • Lynparza
  • AZD 2281
  • AZD-2281
  • AZD2281
  • KU-0059436
  • PARP-hemmer AZD2281
  • KU0059436
  • Olanib
  • Olaparix
  • KU 0059436

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Survival
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tidsramme
Tid fra randomisering til første ikke-studie, anti-kreftbehandling eller død
Tidsramme: Inntil 5 år
Inntil 5 år
Tid fra randomisering til andre ikke-studie, anti-kreftbehandling eller død
Tidsramme: Inntil 5 år
Inntil 5 år

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Cancer Institute (NCI)

Samarbeidspartnere

AstraZeneca
NRG Oncology

Etterforskere

  • Hovedetterforsker: Joyce F Liu, NRG Oncology

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. mars 2016

Primær fullføring (Faktiske)

23. februar 2020

Studiet fullført (Antatt)

4. mars 2027

Datoer for studieregistrering

Først innsendt

11. mai 2015

Først innsendt som oppfylte QC-kriteriene

13. mai 2015

Først lagt ut (Antatt)

18. mai 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NCI-2015-00606
  • U10CA180868 (U.S. NIH-stipend/kontrakt)
  • NCI-2015-00606 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • s16-01480
  • NRG-GY004 (Annen identifikator: CTEP)
  • NRG-GY004
  • NRG-GY004 (Annen identifikator: NRG Oncology)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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