Test de l'utilisation d'un seul médicament (Olaparib) ou de la combinaison de deux médicaments (Cediranib et Olaparib) par rapport à la chimiothérapie habituelle pour les femmes atteintes d'un cancer de l'ovaire, de la trompe de Fallope ou du péritoine primitif sensible au platine
Une étude de phase III comparant l'olaparib en monothérapie ou l'association de cédiranib et d'olaparib à une chimiothérapie standard à base de platine chez des femmes atteintes d'un cancer récurrent de l'ovaire, de la trompe de Fallope ou du péritoine primitif sensible au platine
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.
Aperçu de l'étude
Statut
Les conditions
- Carcinome récurrent des trompes de Fallope
- Carcinome ovarien récurrent
- Carcinome péritonéal primitif récurrent
- Carcinome séromucineux de l'ovaire
- Carcinome indifférencié de l'ovaire
- Adénocarcinome à cellules claires de l'ovaire
- Carcinome à cellules transitionnelles des trompes de Fallope
- Carcinome à cellules transitionnelles de l'ovaire
- Adénocarcinome à cellules claires des trompes de Fallope
- Carcinome indifférencié des trompes de Fallope
- Adénocarcinome endométrioïde ovarien récurrent
- Tumeur endométrioïde ovarienne
- Tumeur séreuse ovarienne
Intervention / Traitement
- Médicament: Carboplatin
- Médicament: Paclitaxel
- Autre: Laboratory Biomarker Analysis
- Autre: Quality-of-Life Assessment
- Procédure: Biospecimen Collection
- Procédure: Computed Tomography
- Procédure: Magnetic Resonance Imaging
- Procédure: Echocardiography Test
- Procédure: Multigated Acquisition Scan
- Autre: Pharmacological Study
- Médicament: Gemcitabine Hydrochloride
- Médicament: Cediranib Maleate
- Médicament: Olaparib
- Médicament: Gemcitabine
- Médicament: Pegylated Liposomal Doxorubicin Hydrochloride
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
- Arthur J E Child Comprehensive Cancer Centre
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre at Hamilton Health Sciences
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London, Ontario, Canada, N6A 4L6
- London Regional Cancer Program
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital and Cancer Center-General Campus
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Sault Ste. Marie, Ontario, Canada, P6B 0A8
- Algoma District Cancer Program Sault Area Hospital
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Toronto, Ontario, Canada, M5G 2M9
- University Health Network-Princess Margaret Hospital
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Toronto, Ontario, Canada, M4N 3M5
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
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Montreal, Quebec, Canada, H2X 3E4
- CHUM - Centre Hospitalier de l'Universite de Montreal
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Montreal, Quebec, Canada, H1T 2M4
- CIUSSSEMTL-Hopital Maisonneuve-Rosemont
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Québec, Quebec, Canada, G1R 2J6
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
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Seoul, Corée du Sud, 110-744
- Seoul National University Hospital
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Saitama, Japon, 350-1298
- Saitama Medical University International Medical Center
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Tokyo, Japon, 104 0045
- National Cancer Center Hospital
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Iwate
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Shiwa-gun, Iwate, Japon, 028-3695
- Iwate Medical University Hospital
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japon, 890-8760
- Kagoshima City Hospital
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Tokyo
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Koto-ku, Tokyo, Japon, 135-8550
- The Cancer Institute Hospital Of JFCR
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- University of Alabama at Birmingham Cancer Center
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Mobile, Alabama, États-Unis, 36688
- University of South Alabama Mitchell Cancer Institute
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Alaska
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Anchorage, Alaska, États-Unis, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, États-Unis, 99508
- Providence Alaska Medical Center
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Arizona
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Tucson, Arizona, États-Unis, 85704
- Arizona Oncology Associates-West Orange Grove
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Tucson, Arizona, États-Unis, 85710
- Arizona Oncology Associates-Wilmot
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Arkansas
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Little Rock, Arkansas, États-Unis, 72205
- University of Arkansas for Medical Sciences
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California
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Arroyo Grande, California, États-Unis, 93420
- PCR Oncology
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Carmichael, California, États-Unis, 95608
- Mercy San Juan Medical Center
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Greenbrae, California, États-Unis, 94904
- Marin Cancer Care Inc
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La Jolla, California, États-Unis, 92093
- UC San Diego Moores Cancer Center
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Los Angeles, California, États-Unis, 90048
- Cedars-Sinai Medical Center
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Mountain View, California, États-Unis, 94040
- Palo Alto Medical Foundation-Camino Division
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Mountain View, California, États-Unis, 94040
- Palo Alto Medical Foundation-Gynecologic Oncology
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Oakland, California, États-Unis, 94611
- Kaiser Permanente-Oakland
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Palo Alto, California, États-Unis, 94301
- Palo Alto Medical Foundation Health Care
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Roseville, California, États-Unis, 95661
- Sutter Roseville Medical Center
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Sacramento, California, États-Unis, 95816
- Sutter Medical Center Sacramento
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Sacramento, California, États-Unis, 95817
- University of California Davis Comprehensive Cancer Center
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Sacramento, California, États-Unis, 95825
- Kaiser Permanente Sacramento Medical Center
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Sacramento, California, États-Unis, 95816
- Mercy Cancer Center - Sacramento
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San Francisco, California, États-Unis, 94115
- Kaiser Permanente-San Francisco
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San Francisco, California, États-Unis, 94158
- UCSF Medical Center-Mission Bay
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San Francisco, California, États-Unis, 94115
- California Pacific Medical Center-Pacific Campus
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San Luis Obispo, California, États-Unis, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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Santa Clara, California, États-Unis, 95051
- Kaiser Permanente Medical Center - Santa Clara
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Santa Cruz, California, États-Unis, 95065
- Palo Alto Medical Foundation-Santa Cruz
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Santa Rosa, California, États-Unis, 95403
- Sutter Pacific Medical Foundation
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Sunnyvale, California, États-Unis, 94086
- Palo Alto Medical Foundation-Sunnyvale
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Vallejo, California, États-Unis, 94589
- Kaiser Permanente-Vallejo
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Walnut Creek, California, États-Unis, 94596
- Kaiser Permanente-Walnut Creek
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Woodland, California, États-Unis, 95695
- Woodland Memorial Hospital
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Colorado
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Aurora, Colorado, États-Unis, 80012
- Rocky Mountain Cancer Centers-Aurora
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Aurora, Colorado, États-Unis, 80045
- UCHealth University of Colorado Hospital
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Colorado Springs, Colorado, États-Unis, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, États-Unis, 80909
- UCHealth Memorial Hospital Central
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Denver, Colorado, États-Unis, 80205
- Kaiser Permanente-Franklin
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Denver, Colorado, États-Unis, 80220
- Rocky Mountain Cancer Centers-Rose
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Fort Collins, Colorado, États-Unis, 80524
- Poudre Valley Hospital
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Lafayette, Colorado, États-Unis, 80026
- Kaiser Permanente-Rock Creek
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Littleton, Colorado, États-Unis, 80120
- Rocky Mountain Cancer Centers-Littleton
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Lone Tree, Colorado, États-Unis, 80124
- Kaiser Permanente-Lone Tree
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Lone Tree, Colorado, États-Unis, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Wheat Ridge, Colorado, États-Unis, 80401
- Intermountain Health Lutheran Hospital
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Connecticut
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Fairfield, Connecticut, États-Unis, 06824
- Smilow Cancer Hospital Care Center-Fairfield
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Hartford, Connecticut, États-Unis, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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Hartford, Connecticut, États-Unis, 06102
- Hartford Hospital
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Middletown, Connecticut, États-Unis, 06457
- Middlesex Hospital
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New Britain, Connecticut, États-Unis, 06050
- The Hospital of Central Connecticut
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New Haven, Connecticut, États-Unis, 06520
- Yale University
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Torrington, Connecticut, États-Unis, 06790
- Smilow Cancer Hospital-Torrington Care Center
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Trumbull, Connecticut, États-Unis, 06611
- Smilow Cancer Hospital Care Center-Trumbull
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Delaware
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Newark, Delaware, États-Unis, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, États-Unis, 19718
- Christiana Care Health System-Christiana Hospital
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Rehoboth Beach, Delaware, États-Unis, 19971
- Beebe Health Campus
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Seaford, Delaware, États-Unis, 19973
- TidalHealth Nanticoke / Allen Cancer Center
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District of Columbia
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Washington D.C., District of Columbia, États-Unis, 20016
- Sibley Memorial Hospital
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Florida
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Gainesville, Florida, États-Unis, 32610
- UF Health Cancer Institute - Gainesville
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Georgia
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Athens, Georgia, États-Unis, 30607
- University Cancer and Blood Center LLC
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Atlanta, Georgia, États-Unis, 30309
- Piedmont Hospital
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Atlanta, Georgia, États-Unis, 30342
- Northside Hospital
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Decatur, Georgia, États-Unis, 30033
- Emory Decatur Hospital
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Macon, Georgia, États-Unis, 31201
- Atrium Health Navicent
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Savannah, Georgia, États-Unis, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Savannah, Georgia, États-Unis, 31404
- Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, États-Unis, 96813
- Queen's Medical Center
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Honolulu, Hawaii, États-Unis, 96826
- Kapiolani Medical Center for Women and Children
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Idaho
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Boise, Idaho, États-Unis, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, États-Unis, 83712
- Saint Luke's Cancer Institute - Boise
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Fruitland, Idaho, États-Unis, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, États-Unis, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, États-Unis, 83687
- Saint Luke's Cancer Institute - Nampa
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Illinois
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Aurora, Illinois, États-Unis, 60504
- Rush-Copley Medical Center
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Bloomington, Illinois, États-Unis, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, États-Unis, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, États-Unis, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, États-Unis, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, États-Unis, 60611
- Northwestern University
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Chicago, Illinois, États-Unis, 60612
- John H Stroger Jr Hospital of Cook County
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Chicago, Illinois, États-Unis, 60657
- UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
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Chicago, Illinois, États-Unis, 60612
- Rush MD Anderson Cancer Center
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Decatur, Illinois, États-Unis, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, États-Unis, 62526
- Cancer Care Specialists of Illinois - Decatur
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Effingham, Illinois, États-Unis, 62401
- Crossroads Cancer Center
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Eureka, Illinois, États-Unis, 61530
- Illinois CancerCare-Eureka
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Evanston, Illinois, États-Unis, 60201
- NorthShore University HealthSystem-Evanston Hospital
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Galesburg, Illinois, États-Unis, 61401
- Illinois CancerCare-Galesburg
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Geneva, Illinois, États-Unis, 60134
- Northwestern Medicine Cancer Center Delnor
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Glenview, Illinois, États-Unis, 60026
- NorthShore University HealthSystem-Glenbrook Hospital
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Highland Park, Illinois, États-Unis, 60035
- NorthShore University HealthSystem-Highland Park Hospital
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Hinsdale, Illinois, États-Unis, 60521
- Sudarshan K Sharma MD Limited-Gynecologic Oncology
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Kewanee, Illinois, États-Unis, 61443
- Illinois CancerCare-Kewanee Clinic
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Macomb, Illinois, États-Unis, 61455
- Illinois CancerCare-Macomb
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O'Fallon, Illinois, États-Unis, 62269
- Cancer Care Center of O'Fallon
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Ottawa, Illinois, États-Unis, 61350
- Illinois CancerCare-Ottawa Clinic
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Park Ridge, Illinois, États-Unis, 60068
- Advocate Lutheran General Hospital
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Pekin, Illinois, États-Unis, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, États-Unis, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, États-Unis, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, États-Unis, 61356
- Illinois CancerCare-Princeton
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Springfield, Illinois, États-Unis, 62702
- Springfield Clinic
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Springfield, Illinois, États-Unis, 62781
- Springfield Memorial Hospital
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Warrenville, Illinois, États-Unis, 60555
- Northwestern Medicine Cancer Center Warrenville
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Indiana
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Indianapolis, Indiana, États-Unis, 46260
- Ascension Saint Vincent Indianapolis Hospital
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Iowa
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Clive, Iowa, États-Unis, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, États-Unis, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Des Moines, Iowa, États-Unis, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, États-Unis, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, États-Unis, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, États-Unis, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Iowa City, Iowa, États-Unis, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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West Des Moines, Iowa, États-Unis, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Kansas City, Kansas, États-Unis, 66160
- University of Kansas Cancer Center
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Pittsburg, Kansas, États-Unis, 66762
- Mercy Hospital Pittsburg
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Topeka, Kansas, États-Unis, 66606
- Cotton O'Neil Cancer Center / Stormont Vail Health
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Wichita, Kansas, États-Unis, 67214
- Ascension Via Christi Hospitals Wichita
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Wichita, Kansas, États-Unis, 67208
- Associates In Womens Health
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Kentucky
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Lexington, Kentucky, États-Unis, 40536
- University of Kentucky/Markey Cancer Center
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Louisville, Kentucky, États-Unis, 40202
- Norton Hospital Pavilion and Medical Campus
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Louisville, Kentucky, États-Unis, 40241
- Norton Brownsboro Hospital and Medical Campus
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Louisville, Kentucky, États-Unis, 40207
- Norton Suburban Hospital and Medical Campus
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Louisiana
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Baton Rouge, Louisiana, États-Unis, 70809
- Mary Bird Perkins Cancer Center
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Baton Rouge, Louisiana, États-Unis, 70817
- Woman's Hospital
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Covington, Louisiana, États-Unis, 70433
- Women's Cancer Care-Covington
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New Orleans, Louisiana, États-Unis, 70121
- Ochsner Medical Center Jefferson
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Maine
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Bangor, Maine, États-Unis, 04401
- Eastern Maine Medical Center
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Brewer, Maine, États-Unis, 04412
- Lafayette Family Cancer Center-EMMC
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Scarborough, Maine, États-Unis, 04074
- MaineHealth Maine Medical Center- Scarborough
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Maryland
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Baltimore, Maryland, États-Unis, 21237
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
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Baltimore, Maryland, États-Unis, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Baltimore, Maryland, États-Unis, 21204
- Greater Baltimore Medical Center
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Easton, Maryland, États-Unis, 21601
- University of Maryland Shore Medical Center at Easton
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, États-Unis, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, États-Unis, 02111
- Tufts Medical Center
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Burlington, Massachusetts, États-Unis, 01805
- Lahey Clinic
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan Rogel Cancer Center
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Ann Arbor, Michigan, États-Unis, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Brownstown, Michigan, États-Unis, 48183
- Henry Ford Cancer Institute-Downriver
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Clinton Township, Michigan, États-Unis, 48038
- Henry Ford Macomb Hospital-Clinton Township
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Detroit, Michigan, États-Unis, 48202
- Henry Ford Hospital
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Detroit, Michigan, États-Unis, 48201
- Wayne State University/Karmanos Cancer Institute
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Escanaba, Michigan, États-Unis, 49829
- OSF Saint Francis Hospital and Medical Group
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Farmington Hills, Michigan, États-Unis, 48334
- Weisberg Cancer Treatment Center
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Flint, Michigan, États-Unis, 48503
- Hurley Medical Center
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Flint, Michigan, États-Unis, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, États-Unis, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Kalamazoo, Michigan, États-Unis, 49007
- West Michigan Cancer Center
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Lansing, Michigan, États-Unis, 48912
- University of Michigan Health - Sparrow Lansing
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Manistique, Michigan, États-Unis, 49854
- Schoolcraft Memorial Hospital
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Pontiac, Michigan, États-Unis, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
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Southfield, Michigan, États-Unis, 48075
- Henry Ford Health Providence Southfield Hospital
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Traverse City, Michigan, États-Unis, 49684
- Munson Medical Center
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West Bloomfield, Michigan, États-Unis, 48322
- Henry Ford West Bloomfield Hospital
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Minnesota
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Bemidji, Minnesota, États-Unis, 56601
- Sanford Joe Lueken Cancer Center
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Burnsville, Minnesota, États-Unis, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, États-Unis, 55433
- Mercy Hospital
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Edina, Minnesota, États-Unis, 55435
- Fairview Southdale Hospital
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Mankato, Minnesota, États-Unis, 56001
- Mayo Clinic Health Systems-Mankato
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Maple Grove, Minnesota, États-Unis, 55369
- Fairview Clinics and Surgery Center Maple Grove
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Maplewood, Minnesota, États-Unis, 55109
- Saint John's Hospital - Healtheast
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Minneapolis, Minnesota, États-Unis, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota/Masonic Cancer Center
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic in Rochester
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Saint Louis Park, Minnesota, États-Unis, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, États-Unis, 55101
- Regions Hospital
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Saint Paul, Minnesota, États-Unis, 55102
- United Hospital
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Shakopee, Minnesota, États-Unis, 55379
- Saint Francis Regional Medical Center
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Woodbury, Minnesota, États-Unis, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Mississippi
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Jackson, Mississippi, États-Unis, 39216
- University of Mississippi Medical Center
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Jackson, Mississippi, États-Unis, 39216
- Saint Dominic-Jackson Memorial Hospital
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Missouri
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Cape Girardeau, Missouri, États-Unis, 63703
- Saint Francis Medical Center
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Joplin, Missouri, États-Unis, 64804
- Mercy Hospital Joplin
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Springfield, Missouri, États-Unis, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, États-Unis, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, États-Unis, 63110
- Barnes-Jewish Hospital
-
St Louis, Missouri, États-Unis, 63110
- Washington University School of Medicine
-
-
Montana
-
Billings, Montana, États-Unis, 59101
- Billings Clinic Cancer Center
-
Great Falls, Montana, États-Unis, 59405
- Benefis Sletten Cancer Institute
-
Kalispell, Montana, États-Unis, 59901
- Logan Health Medical Center
-
Missoula, Montana, États-Unis, 59804
- Community Medical Center
-
-
Nebraska
-
Grand Island, Nebraska, États-Unis, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
-
Kearney, Nebraska, États-Unis, 68847
- CHI Health Good Samaritan
-
Omaha, Nebraska, États-Unis, 68114
- Nebraska Methodist Hospital
-
Omaha, Nebraska, États-Unis, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, États-Unis, 68130
- Alegent Health Lakeside Hospital
-
-
Nevada
-
Las Vegas, Nevada, États-Unis, 89106
- Women's Cancer Center of Nevada
-
-
New Hampshire
-
Dover, New Hampshire, États-Unis, 03820
- Wentworth-Douglass Hospital
-
Lebanon, New Hampshire, États-Unis, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
Nashua, New Hampshire, États-Unis, 03063
- Dartmouth Cancer Center - Nashua
-
-
New Jersey
-
Basking Ridge, New Jersey, États-Unis, 07920
- Memorial Sloan Kettering Basking Ridge
-
Camden, New Jersey, États-Unis, 08103
- Cooper Hospital University Medical Center
-
Englewood, New Jersey, États-Unis, 07631
- Englewood Hospital and Medical Center
-
Voorhees Township, New Jersey, États-Unis, 08043
- MD Anderson Cancer Center at Cooper-Voorhees
-
-
New Mexico
-
Albuquerque, New Mexico, États-Unis, 87106
- Southwest Gynecologic Oncology Associates Inc
-
Albuquerque, New Mexico, États-Unis, 87106
- University of New Mexico Cancer Center
-
Las Cruces, New Mexico, États-Unis, 88011
- Memorial Medical Center-Las Cruces
-
-
New York
-
Brooklyn, New York, États-Unis, 11203
- State University of New York Downstate Medical Center
-
Buffalo, New York, États-Unis, 14263
- Roswell Park Cancer Institute
-
Commack, New York, États-Unis, 11725
- Memorial Sloan Kettering Commack
-
Harrison, New York, États-Unis, 10604
- Memorial Sloan Kettering Westchester
-
New York, New York, États-Unis, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, États-Unis, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Rochester, New York, États-Unis, 14642
- University of Rochester
-
The Bronx, New York, États-Unis, 10461
- Montefiore Medical Center-Einstein Campus
-
Uniondale, New York, États-Unis, 11553
- Memorial Sloan Kettering Nassau
-
White Plains, New York, États-Unis, 10601
- Dickstein Cancer Treatment Center
-
-
North Carolina
-
Chapel Hill, North Carolina, États-Unis, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Durham, North Carolina, États-Unis, 27710
- Duke University Medical Center
-
Goldsboro, North Carolina, États-Unis, 27534
- Southeastern Medical Oncology Center-Goldsboro
-
Jacksonville, North Carolina, États-Unis, 28546
- Southeastern Medical Oncology Center-Jacksonville
-
Pinehurst, North Carolina, États-Unis, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
-
Raleigh, North Carolina, États-Unis, 27609
- Duke Cancer Center Raleigh
-
Wilmington, North Carolina, États-Unis, 28401
- Novant Health New Hanover Regional Medical Center
-
Winston-Salem, North Carolina, États-Unis, 27157
- Wake Forest University Health Sciences
-
-
North Dakota
-
Bismarck, North Dakota, États-Unis, 58501
- Sanford Bismarck Medical Center
-
Fargo, North Dakota, États-Unis, 58122
- Sanford Roger Maris Cancer Center
-
Fargo, North Dakota, États-Unis, 58122
- Sanford Broadway Medical Center
-
Minot, North Dakota, États-Unis, 58701
- Trinity Cancer Care Center
-
-
Ohio
-
Akron, Ohio, États-Unis, 44307
- Cleveland Clinic Akron General
-
Akron, Ohio, États-Unis, 44304
- Summa Health System - Akron Campus
-
Beachwood, Ohio, États-Unis, 44122
- UHHS-Chagrin Highlands Medical Center
-
Cincinnati, Ohio, États-Unis, 45219
- University of Cincinnati Cancer Center-UC Medical Center
-
Cincinnati, Ohio, États-Unis, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, États-Unis, 45247
- TriHealth Cancer Institute-Westside
-
Cleveland, Ohio, États-Unis, 44106
- Case Western Reserve University
-
Cleveland, Ohio, États-Unis, 44109
- MetroHealth Medical Center
-
Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, États-Unis, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Columbus, Ohio, États-Unis, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, États-Unis, 43210
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, États-Unis, 43219
- The Mark H Zangmeister Center
-
Columbus, Ohio, États-Unis, 43214
- Columbus Oncology and Hematology Associates Inc
-
Dayton, Ohio, États-Unis, 45405
- Grandview Hospital
-
Findlay, Ohio, États-Unis, 45840
- Orion Cancer Care
-
Mayfield Heights, Ohio, États-Unis, 44124
- Hillcrest Hospital Cancer Center
-
Mentor, Ohio, États-Unis, 44060
- UH Seidman Cancer Center at Lake Health Mentor Campus
-
Sylvania, Ohio, États-Unis, 43560
- ProMedica Flower Hospital
-
Toledo, Ohio, États-Unis, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
Wadsworth, Ohio, États-Unis, 44281
- University Hospitals Sharon Health Center
-
Westlake, Ohio, États-Unis, 44145
- UHHS-Westlake Medical Center
-
Wright-Patterson Air Force Base, Ohio, États-Unis, 45433
- Wright-Patterson Medical Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, États-Unis, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, États-Unis, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
-
-
Oregon
-
Bend, Oregon, États-Unis, 97701
- Saint Charles Health System
-
Eugene, Oregon, États-Unis, 97401
- Willamette Valley Cancer Center
-
Gresham, Oregon, États-Unis, 97030
- Legacy Mount Hood Medical Center
-
Portland, Oregon, États-Unis, 97210
- Legacy Good Samaritan Hospital and Medical Center
-
Portland, Oregon, États-Unis, 97227
- Kaiser Permanente Northwest
-
Tualatin, Oregon, États-Unis, 97062
- Legacy Meridian Park Hospital
-
-
Pennsylvania
-
Abington, Pennsylvania, États-Unis, 19001
- Jefferson Abington Hospital
-
Bethlehem, Pennsylvania, États-Unis, 18015
- Saint Luke's University Hospital-Bethlehem Campus
-
Danville, Pennsylvania, États-Unis, 17822
- Geisinger Medical Center
-
Ephrata, Pennsylvania, États-Unis, 17522
- Ephrata Cancer Center
-
Gettysburg, Pennsylvania, États-Unis, 17325
- Adams Cancer Center
-
Lancaster, Pennsylvania, États-Unis, 17602
- Lancaster General Hospital
-
Philadelphia, Pennsylvania, États-Unis, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, États-Unis, 19104
- University of Pennsylvania/Abramson Cancer Center
-
Pittsburgh, Pennsylvania, États-Unis, 15224
- West Penn Hospital
-
Pittsburgh, Pennsylvania, États-Unis, 15232
- UPMC Hillman Cancer Center
-
Sayre, Pennsylvania, États-Unis, 18840
- Guthrie Medical Group PC-Robert Packer Hospital
-
Selinsgrove, Pennsylvania, États-Unis, 17870
- Geisinger Medical Oncology-Selinsgrove
-
West Reading, Pennsylvania, États-Unis, 19611
- Reading Hospital
-
Williamsport, Pennsylvania, États-Unis, 17701
- UPMC Susquehanna
-
York, Pennsylvania, États-Unis, 17403
- WellSpan Health-York Hospital
-
-
Rhode Island
-
Providence, Rhode Island, États-Unis, 02905
- Women and Infants Hospital
-
-
South Carolina
-
Anderson, South Carolina, États-Unis, 29621
- AnMed Health Cancer Center
-
Charleston, South Carolina, États-Unis, 29425
- Medical University of South Carolina
-
Gaffney, South Carolina, États-Unis, 29341
- Gibbs Cancer Center-Gaffney
-
Greenville, South Carolina, États-Unis, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, États-Unis, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, États-Unis, 29601
- Saint Francis Hospital
-
Greer, South Carolina, États-Unis, 29651
- Gibbs Cancer Center-Pelham
-
Hilton Head Island, South Carolina, États-Unis, 29926-3827
- South Carolina Cancer Specialists PC
-
Spartanburg, South Carolina, États-Unis, 29303
- Spartanburg Medical Center
-
Union, South Carolina, États-Unis, 29379
- SMC Center for Hematology Oncology Union
-
-
South Dakota
-
Rapid City, South Dakota, États-Unis, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, États-Unis, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, États-Unis, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls, South Dakota, États-Unis, 57104
- Sanford Cancer Center Oncology Clinic
-
-
Tennessee
-
Johnson City, Tennessee, États-Unis, 37604
- Wellmont Medical Associates Oncology and Hematology-Johnson City
-
Kingsport, Tennessee, États-Unis, 37660
- Ballad Health Cancer Care - Kingsport
-
Kingsport, Tennessee, États-Unis, 37660
- Wellmont Holston Valley Hospital and Medical Center
-
Knoxville, Tennessee, États-Unis, 37916
- Covenant Health Cancer Centers
-
Knoxville, Tennessee, États-Unis, 37932
- Covenant Health Cancer Centers - West
-
Nashville, Tennessee, États-Unis, 37232
- Vanderbilt University/Ingram Cancer Center
-
-
Texas
-
Austin, Texas, États-Unis, 78731
- Texas Oncology - Central Austin Cancer Center
-
Austin, Texas, États-Unis, 78745
- Texas Oncology - South Austin Cancer Center
-
Bedford, Texas, États-Unis, 76022
- Texas Oncology Bedford
-
Dallas, Texas, États-Unis, 75235
- Parkland Memorial Hospital
-
Dallas, Texas, États-Unis, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Fort Worth, Texas, États-Unis, 76104
- Texas Oncology - Fort Worth Cancer Center
-
Houston, Texas, États-Unis, 77030
- Houston Methodist Hospital
-
Houston, Texas, États-Unis, 77070
- Methodist Willowbrook Hospital
-
Sugar Land, Texas, États-Unis, 77479
- Houston Methodist Sugar Land Hospital
-
The Woodlands, Texas, États-Unis, 77380
- Texas Oncology-The Woodlands
-
-
Utah
-
Murray, Utah, États-Unis, 84107
- Intermountain Medical Center
-
Salt Lake City, Utah, États-Unis, 84106
- Utah Cancer Specialists-Salt Lake City
-
St. George, Utah, États-Unis, 84770
- Saint George Regional Medical Center
-
-
Virginia
-
Charlottesville, Virginia, États-Unis, 22908
- University of Virginia Cancer Center
-
Richmond, Virginia, États-Unis, 23298
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Kennewick, Washington, États-Unis, 99336
- Kadlec Clinic Hematology and Oncology
-
Mount Vernon, Washington, États-Unis, 98274
- Skagit Valley Hospital
-
Mount Vernon, Washington, États-Unis, 98274
- Skagit Regional Health Cancer Care Center
-
Seattle, Washington, États-Unis, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, États-Unis, 98195
- University of Washington Medical Center - Montlake
-
Seattle, Washington, États-Unis, 98104
- Pacific Gynecology Specialists
-
Seattle, Washington, États-Unis, 98109
- Fred Hutchinson Cancer Center
-
Seattle, Washington, États-Unis, 98133
- University of Washington Medical Center - Northwest
-
Seattle, Washington, États-Unis, 98133
- Women's Cancer Center of Seattle
-
Vancouver, Washington, États-Unis, 98686
- Legacy Salmon Creek Hospital
-
Wenatchee, Washington, États-Unis, 98801
- Wenatchee Valley Hospital and Clinics
-
-
West Virginia
-
Charleston, West Virginia, États-Unis, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
-
Huntington, West Virginia, États-Unis, 25701
- Edwards Comprehensive Cancer Center
-
-
Wisconsin
-
Chippewa Falls, Wisconsin, États-Unis, 54729
- Marshfield Clinic-Chippewa Center
-
Eau Claire, Wisconsin, États-Unis, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Green Bay, Wisconsin, États-Unis, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, États-Unis, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
La Crosse, Wisconsin, États-Unis, 54601
- Gundersen Lutheran Medical Center
-
Ladysmith, Wisconsin, États-Unis, 54848
- Marshfield Medical Center - Ladysmith
-
Madison, Wisconsin, États-Unis, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Marinette, Wisconsin, États-Unis, 54143
- Saint Vincent Hospital Cancer Center at Marinette
-
Marshfield, Wisconsin, États-Unis, 54449
- Marshfield Medical Center-Marshfield
-
Milwaukee, Wisconsin, États-Unis, 53226
- Medical College of Wisconsin
-
Minocqua, Wisconsin, États-Unis, 54548
- Marshfield Medical Center - Minocqua
-
Mukwonago, Wisconsin, États-Unis, 53149
- ProHealth D N Greenwald Center
-
Oconomowoc, Wisconsin, États-Unis, 53066
- ProHealth Oconomowoc Memorial Hospital
-
Oconto Falls, Wisconsin, États-Unis, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Rice Lake, Wisconsin, États-Unis, 54868
- Marshfield Medical Center-Rice Lake
-
Stevens Point, Wisconsin, États-Unis, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Stevens Point, Wisconsin, États-Unis, 54481
- Aspirus Cancer Care - Stevens Point
-
Sturgeon Bay, Wisconsin, États-Unis, 54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Waukesha, Wisconsin, États-Unis, 53188
- UW Cancer Center at ProHealth Care
-
Waukesha, Wisconsin, États-Unis, 53188
- ProHealth Waukesha Memorial Hospital
-
Wausau, Wisconsin, États-Unis, 54401
- Marshfield Clinic-Wausau Center
-
Weston, Wisconsin, États-Unis, 54476
- Marshfield Medical Center - Weston
-
Wisconsin Rapids, Wisconsin, États-Unis, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Arm I (platinum-based chemotherapy)
See detailed description. |
Given IV
Autres noms:
Given IV
Autres noms:
Correlative studies Ancillary studies
Autres noms:
Undergo CT
Autres noms:
Undergo MRI
Autres noms:
Undergo ECHO
Autres noms:
Undergo MUGA
Autres noms:
Given IV
Autres noms:
Given IV
Autres noms:
Given IV
Autres noms:
|
|
Expérimental: 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. |
Correlative studies Ancillary studies
Autres noms:
Undergo blood sample collection
Autres noms:
Undergo CT
Autres noms:
Undergo MRI
Autres noms:
Undergo ECHO
Autres noms:
Undergo MUGA
Autres noms:
Correlative studies Given PO
Autres noms:
|
|
Expérimental: 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. |
Correlative studies Ancillary studies
Autres noms:
Undergo blood sample collection
Autres noms:
Undergo CT
Autres noms:
Undergo MRI
Autres noms:
Undergo ECHO
Autres noms:
Undergo MUGA
Autres noms:
Correlative studies Given PO
Autres noms:
Given PO
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Délai |
|---|---|
|
Délai entre la randomisation et la première non-étude, le traitement anticancéreux ou le décès
Délai: Jusqu'à 5 ans
|
Jusqu'à 5 ans
|
|
Délai entre la randomisation et la deuxième non-étude, le traitement anticancéreux ou le décès
Délai: Jusqu'à 5 ans
|
Jusqu'à 5 ans
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Joyce F Liu, NRG Oncology
Publications et liens utiles
Publications générales
- Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
- Liu JF, Brady MF, Matulonis UA, Miller A, Kohn EC, Swisher EM, Cella D, Tew WP, Cloven NG, Muller CY, Bender DP, Moore RG, Michelin DP, Waggoner SE, Geller MA, Fujiwara K, D'Andre SD, Carney M, Alvarez Secord A, Moxley KM, Bookman MA. Olaparib With or Without Cediranib Versus Platinum-Based Chemotherapy in Recurrent Platinum-Sensitive Ovarian Cancer (NRG-GY004): A Randomized, Open-Label, Phase III Trial. J Clin Oncol. 2022 Jul 1;40(19):2138-2147. doi: 10.1200/JCO.21.02011. Epub 2022 Mar 15.
- Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Maladies du système endocrinien
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies génitales, femme
- Tumeurs des glandes endocrines
- Maladies ovariennes
- Maladies annexielles
- Tumeurs génitales, femme
- Troubles gonadiques
- Maladies des trompes de Fallope
- Tumeurs ovariennes
- Tumeurs des trompes de Fallope
- Produits chimiques organiques
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Techniques d'investigation
- Techniques de laboratoire clinique
- Techniques et procédures de diagnostic
- Diagnostic
- Hydrocarbures
- Cycloparaffines
- Hydrocarbures, alicyclique
- Hydrocarbures, cyclique
- Terpènes
- Glucides
- Hydrocarbures aromatiques polycycliques
- Hydrocarbures, aromatique
- Composés polycycliques
- Glycosides
- Complexes de coordination
- Taxes
- Cyclodécanes
- Diterpènes
- Désoxycytidine
- Cytidine
- Nucléosides pyrimidine
- Pyrimidines
- Économie et organisations des soins de santé
- Techniques de chimie, analytique
- Analyse du spectre
- Anthracyclines
- Naphtacènes
- Aminoglycosides
- Daunorubicine
- Économie
- Gemcitabine
- Carboplatine
- Doxorubicine
- Paclitaxel
- Manipulation des échantillons
- Spectroscopie de résonance magnétique
- doxorubicine liposomale
- olaparib
- cédiranib
- Taxes
Autres numéros d'identification d'étude
- NCI-2015-00606
- U10CA180868 (Subvention/contrat des NIH des États-Unis)
- NCI-2015-00606 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- s16-01480
- NRG-GY004 (Autre identifiant: CTEP)
- NRG-GY004
- NRG-GY004 (Autre identifiant: NRG Oncology)
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