Prueba de la combinación de cediranib y olaparib en comparación con cada fármaco solo u otra quimioterapia en el cáncer de ovario recurrente resistente al platino
Un estudio aleatorizado de fase II/III de la combinación de cediranib y olaparib en comparación con cediranib u olaparib solo, o quimioterapia de atención estándar en mujeres con cáncer de ovario, de trompas de Falopio o peritoneal primario recurrente resistente al platino o refractario al platino (COCOS)
This randomized phase II/III trial studies how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned (recurrent) after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Chemotherapy drugs 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 giving cediranib maleate and olaparib together may cause more damage to cancer cells when compared to either drug alone or standard chemotherapy.
Descripción general del estudio
Estado
Condiciones
- Carcinoma de trompa de Falopio recidivante
- Carcinoma de ovario recurrente
- Carcinoma peritoneal primario recidivante
- Adenocarcinoma endometrioide de ovario
- Carcinoma seromucinoso de ovario
- Carcinoma indiferenciado de ovario
- Adenocarcinoma de células claras de ovario
- Carcinoma de células de transición de las trompas de Falopio
- Carcinoma de células de transición de ovario
- Adenocarcinoma de células claras de las trompas de Falopio
- Adenocarcinoma endometrioide de las trompas de Falopio
- Adenocarcinoma seroso de las trompas de Falopio
- Carcinoma indiferenciado de las trompas de Falopio
- Adenocarcinoma seroso de ovario
- Adenocarcinoma seroso peritoneal primario
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. To assess the efficacy and identify (in)active arm(s) of the combination of cediranib maleate (cediranib) and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by progression-free survival (PFS) in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase II) II. To assess the efficacy of the combination of cediranib and olaparib, and cediranib monotherapy, as measured by overall survival (OS) and PFS, as compared to physician's choice standard of care chemotherapy in women with recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase III)
SECONDARY OBJECTIVES:
I. To assess the efficacy of the combination of cediranib and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by objective response rate (ORR: partial or complete response) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase II) II. To assess safety endpoints, as measured by frequency and severity of adverse events by Common Terminology Criteria for Adverse Events (CTCAE). (Phase II and Phase III) III. To assess the efficacy of the combination of cediranib and olaparib, and cediranib monotherapy, as measured by ORR as compared to physician's choice standard of care chemotherapy in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase III)
OBJECTIVES WITH INTEGRATED BIOMARKERS:
I. To assess correlation of homologous recombination deficiency (HRD) status, as assessed via BROCA-HR assay with response, as measured by PFS and ORR. (Phase II) II. To evaluate the prognostic and predictive role of circulating endothelial cells (CEC) on comparative effectiveness of targeted therapies and reference chemotherapy. (Phase II) III. To evaluate quality of life data compliance, as measured by the 9-item Disease Related Symptoms (DRS-9) subscale of the National Comprehensive Cancer Network (NCCN)-Functional Assessment of Cancer Therapy (FACT) Ovarian Symptom Index (NFOSI) for utilization and analysis in the Phase III study. (Phase II) IV. To assess correlation of HRD status, as assessed via BROCA-HR assay with response, as measured by OS, PFS and ORR. (Phase III) V. To evaluate the prognostic and predictive role of circulating endothelial cells (CEC) on comparative effectiveness of targeted therapies and reference chemotherapy. (Phase III) VI. To assess the effect on disease-related symptoms (DRS) as measured by the 9-item DRS-P subscale of the NCCN-FACT Ovarian Symptom Index-18 (NFOSI-18), of single agent cediranib and cediranib/olaparib combination, compared to standard chemotherapy, in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase III)
EXPLORATORY OBJECTIVES:
I. To assess exploratory biomarkers of potential HRD, including genomic scarring, BRCA1 methylation, BRCA1 protein expression, and mutations in NHEJ, and other genes that might modify HRD. (Phase II and Phase III) II. To evaluate the prognostic and predictive role of angiogenic biomarkers, as assessed by the Duke plasma angiome. (Phase II and Phase III) III. To 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/GOG-Ntx-4, and health utility as measured by the EQ-5D, of single agent cediranib and cediranib/olaparib combination, compared to standard chemotherapy, in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase III)
OUTLINE:
PHASE II: Patients are randomized to 1 of 4 treatment arms.
ARM I (REFERENCE REGIMEN): Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) throughout the study. (12/05/2016)
ARM II (CEDIRANIB MALEATE AND OLAPARIB): Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
ARM III (CEDIRANIB): Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
ARM IV (OLAPARIB): Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).
PHASE III: Patients are randomized to 1 of 3 treatment arms.
ARM I (REFERENCE REGIMEN): Patients undergo physician's choice standard of care chemotherapy as in Phase II Arm I. No modification of the assigned regimens, such as additional drugs (gemcitabine or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)
ARM II (CEDIRANIB AND OLAPARIB): Patients receive cediranib maleate PO and olaparib PO as in Phase II Arm II. Patients also undergo CT and MRI throughout the study.
ARM III (SINGLE AGENT): Patients receive cediranib maleate PO as determined by the Phase II study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for up to 3 years.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá, T2N 5G2
- Arthur J E Child Comprehensive Cancer Centre
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Edmonton, Alberta, Canadá, T6G 1Z2
- Cross Cancer Institute
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Ontario
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Barrie, Ontario, Canadá, L4M 6M2
- Royal Victoria Regional Health Centre
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Hamilton, Ontario, Canadá, L8V 5C2
- Juravinski Cancer Centre at Hamilton Health Sciences
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Kingston, Ontario, Canadá, K7L 2V7
- Kingston Health Sciences Centre
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London, Ontario, Canadá, N6A 4L6
- London Regional Cancer Program
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Sault Ste. Marie, Ontario, Canadá, P6B 0A8
- Algoma District Cancer Program Sault Area Hospital
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Toronto, Ontario, Canadá, M5G 2M9
- University Health Network-Princess Margaret Hospital
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Toronto, Ontario, Canadá, M4N 3M5
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canadá, H3T 1E2
- Jewish General Hospital
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Montreal, Quebec, Canadá, H2X 3E4
- CHUM - Centre Hospitalier de l'Universite de Montreal
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Montreal, Quebec, Canadá, H1T 2M4
- CIUSSSEMTL-Hopital Maisonneuve-Rosemont
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Québec, Quebec, Canadá, G1R 2J6
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
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Incheon, Corea del Sur, 405-760
- Gachon University Gil Hospital
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Seoul, Corea del Sur, 05505
- Asan Medical Center
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Seoul, Corea del Sur, 06273
- Gangnam Severance Hospital
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Seoul, Corea del Sur, 134-727
- Kyung Hee University Hospital at Gangdong
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Seoul, Corea del Sur, 139-706
- Korea Cancer Center Hospital
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Daegu
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Dalseo-gu, Daegu, Corea del Sur, 42601
- Keimyung University-Dongsan Medical Center
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Kyeonggi-do
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Seongnam, Kyeonggi-do, Corea del Sur, 463-707
- Seoul National University Bundang Hospital
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- University of Alabama at Birmingham Cancer Center
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Alaska
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Anchorage, Alaska, Estados Unidos, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, Estados Unidos, 99508
- Providence Alaska Medical Center
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- University of Arkansas for Medical Sciences
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California
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Auburn, California, Estados Unidos, 95602
- Sutter Auburn Faith Hospital
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Berkeley, California, Estados Unidos, 94704
- Alta Bates Summit Medical Center-Herrick Campus
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Carmichael, California, Estados Unidos, 95608
- Mercy San Juan Medical Center
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Elk Grove, California, Estados Unidos, 95758
- Mercy Cancer Center - Elk Grove
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Greenbrae, California, Estados Unidos, 94904
- Marin Cancer Care Inc
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La Jolla, California, Estados Unidos, 92093
- UC San Diego Moores Cancer Center
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Mountain View, California, Estados Unidos, 94040
- Palo Alto Medical Foundation-Camino Division
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Mountain View, California, Estados Unidos, 94040
- Palo Alto Medical Foundation-Gynecologic Oncology
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Oakland, California, Estados Unidos, 94611
- Kaiser Permanente-Oakland
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Palo Alto, California, Estados Unidos, 94301
- Palo Alto Medical Foundation Health Care
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Rocklin, California, Estados Unidos, 95765
- Mercy Cancer Center - Rocklin
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Roseville, California, Estados Unidos, 95661
- Sutter Roseville Medical Center
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Sacramento, California, Estados Unidos, 95816
- Sutter Medical Center Sacramento
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Sacramento, California, Estados Unidos, 95817
- University of California Davis Comprehensive Cancer Center
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Sacramento, California, Estados Unidos, 95814
- Kaiser Permanente Downtown Commons
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Sacramento, California, Estados Unidos, 95825
- Kaiser Permanente Sacramento Medical Center
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Sacramento, California, Estados Unidos, 95816
- Mercy Cancer Center - Sacramento
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San Francisco, California, Estados Unidos, 94115
- Kaiser Permanente-San Francisco
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San Francisco, California, Estados Unidos, 94158
- UCSF Medical Center-Mission Bay
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San Francisco, California, Estados Unidos, 94115
- California Pacific Medical Center-Pacific Campus
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San Luis Obispo, California, Estados Unidos, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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Santa Clara, California, Estados Unidos, 95051
- Kaiser Permanente Medical Center - Santa Clara
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Santa Cruz, California, Estados Unidos, 95065
- Palo Alto Medical Foundation-Santa Cruz
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Santa Rosa, California, Estados Unidos, 95403
- Sutter Pacific Medical Foundation
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Sunnyvale, California, Estados Unidos, 94086
- Palo Alto Medical Foundation-Sunnyvale
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Vallejo, California, Estados Unidos, 94589
- Kaiser Permanente-Vallejo
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Walnut Creek, California, Estados Unidos, 94596
- Kaiser Permanente-Walnut Creek
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Woodland, California, Estados Unidos, 95695
- Woodland Memorial Hospital
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- UCHealth University of Colorado Hospital
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Colorado Springs, Colorado, Estados Unidos, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Estados Unidos, 80909
- UCHealth Memorial Hospital Central
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Denver, Colorado, Estados Unidos, 80205
- Kaiser Permanente-Franklin
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Denver, Colorado, Estados Unidos, 80220
- Rocky Mountain Cancer Centers-Rose
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Fort Collins, Colorado, Estados Unidos, 80524
- Poudre Valley Hospital
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Highlands Ranch, Colorado, Estados Unidos, 80129
- UCHealth Highlands Ranch Hospital
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Lafayette, Colorado, Estados Unidos, 80026
- Kaiser Permanente-Rock Creek
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Lone Tree, Colorado, Estados Unidos, 80124
- Kaiser Permanente-Lone Tree
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Connecticut
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Danbury, Connecticut, Estados Unidos, 06810
- Danbury Hospital
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Fairfield, Connecticut, Estados Unidos, 06824
- Smilow Cancer Hospital Care Center-Fairfield
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Hartford, Connecticut, Estados Unidos, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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Hartford, Connecticut, Estados Unidos, 06102
- Hartford Hospital
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Middletown, Connecticut, Estados Unidos, 06457
- Middlesex Hospital
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New Britain, Connecticut, Estados Unidos, 06050
- The Hospital of Central Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Yale University
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Norwalk, Connecticut, Estados Unidos, 06856
- Norwalk Hospital
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Trumbull, Connecticut, Estados Unidos, 06611
- Smilow Cancer Hospital Care Center-Trumbull
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Delaware
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Newark, Delaware, Estados Unidos, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Estados Unidos, 19713
- Medical Oncology Hematology Consultants PA
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Newark, Delaware, Estados Unidos, 19718
- Christiana Care Health System-Christiana Hospital
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20016
- Sibley Memorial Hospital
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Florida
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Gainesville, Florida, Estados Unidos, 32610
- UF Health Cancer Institute - Gainesville
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Miami Beach, Florida, Estados Unidos, 33140
- Mount Sinai Medical Center
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Orlando, Florida, Estados Unidos, 32806
- Orlando Health Cancer Institute
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Sarasota, Florida, Estados Unidos, 34239
- Sarasota Memorial Hospital
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Georgia
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Atlanta, Georgia, Estados Unidos, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, Estados Unidos, 30309
- Piedmont Hospital
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Atlanta, Georgia, Estados Unidos, 30342
- Northside Hospital
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Augusta, Georgia, Estados Unidos, 30912
- Augusta University Medical Center
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Austell, Georgia, Estados Unidos, 30106
- WellStar Cobb Hospital
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Marietta, Georgia, Estados Unidos, 30060
- Wellstar Kennestone Hospital
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Marietta, Georgia, Estados Unidos, 30060
- WellStar Health System Inc
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Roswell, Georgia, Estados Unidos, 30076
- WellStar North Fulton Hospital
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Savannah, Georgia, Estados Unidos, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Savannah, Georgia, Estados Unidos, 31404
- Memorial Health University Medical Center
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Smyrna, Georgia, Estados Unidos, 30080
- WellStar Vinings Health Park
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96813
- Queen's Medical Center
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Honolulu, Hawaii, Estados Unidos, 96826
- Kapiolani Medical Center for Women and Children
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Idaho
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Boise, Idaho, Estados Unidos, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Estados Unidos, 83712
- Saint Luke's Cancer Institute - Boise
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Fruitland, Idaho, Estados Unidos, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Estados Unidos, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Estados Unidos, 83687
- Saint Luke's Cancer Institute - Nampa
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Illinois
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Aurora, Illinois, Estados Unidos, 60504
- Rush-Copley Medical Center
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Bloomington, Illinois, Estados Unidos, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Estados Unidos, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Estados Unidos, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Estados Unidos, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Chicago, Illinois, Estados Unidos, 60612
- John H Stroger Jr Hospital of Cook County
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Chicago, Illinois, Estados Unidos, 60657
- UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
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Chicago, Illinois, Estados Unidos, 60612
- Rush MD Anderson Cancer Center
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Decatur, Illinois, Estados Unidos, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Estados Unidos, 62526
- Cancer Care Specialists of Illinois - Decatur
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Effingham, Illinois, Estados Unidos, 62401
- Crossroads Cancer Center
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Eureka, Illinois, Estados Unidos, 61530
- Illinois CancerCare-Eureka
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Evanston, Illinois, Estados Unidos, 60201
- NorthShore University HealthSystem-Evanston Hospital
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Galesburg, Illinois, Estados Unidos, 61401
- Illinois CancerCare-Galesburg
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Geneva, Illinois, Estados Unidos, 60134
- Northwestern Medicine Cancer Center Delnor
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Glenview, Illinois, Estados Unidos, 60026
- NorthShore University HealthSystem-Glenbrook Hospital
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Highland Park, Illinois, Estados Unidos, 60035
- NorthShore University HealthSystem-Highland Park Hospital
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Hinsdale, Illinois, Estados Unidos, 60521
- Sudarshan K Sharma MD Limited-Gynecologic Oncology
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Kewanee, Illinois, Estados Unidos, 61443
- Illinois CancerCare-Kewanee Clinic
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Macomb, Illinois, Estados Unidos, 61455
- Illinois CancerCare-Macomb
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O'Fallon, Illinois, Estados Unidos, 62269
- Cancer Care Center of O'Fallon
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Ottawa, Illinois, Estados Unidos, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Estados Unidos, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Estados Unidos, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Estados Unidos, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, Estados Unidos, 61356
- Illinois CancerCare-Princeton
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Springfield, Illinois, Estados Unidos, 62702
- Springfield Clinic
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Springfield, Illinois, Estados Unidos, 62781
- Springfield Memorial Hospital
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Warrenville, Illinois, Estados Unidos, 60555
- Northwestern Medicine Cancer Center Warrenville
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Zion, Illinois, Estados Unidos, 60099
- Midwestern Regional Medical Center
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Indiana
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Fort Wayne, Indiana, Estados Unidos, 46845
- Parkview Regional Medical Center
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Estados Unidos, 46260
- Ascension Saint Vincent Indianapolis Hospital
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Richmond, Indiana, Estados Unidos, 47374
- Reid Health
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South Bend, Indiana, Estados Unidos, 46601
- Memorial Hospital of South Bend
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Iowa
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Clive, Iowa, Estados Unidos, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Estados Unidos, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Des Moines, Iowa, Estados Unidos, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Estados Unidos, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Estados Unidos, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Estados Unidos, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Sioux City, Iowa, Estados Unidos, 51101
- Siouxland Regional Cancer Center
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West Des Moines, Iowa, Estados Unidos, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Wichita, Kansas, Estados Unidos, 67214
- Ascension Via Christi Hospitals Wichita
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Wichita, Kansas, Estados Unidos, 67208
- Associates In Womens Health
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Kentucky
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Edgewood, Kentucky, Estados Unidos, 41017
- Saint Elizabeth Healthcare Edgewood
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Lexington, Kentucky, Estados Unidos, 40536
- University of Kentucky/Markey Cancer Center
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809
- Mary Bird Perkins Cancer Center
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Baton Rouge, Louisiana, Estados Unidos, 70809
- Hematology/Oncology Clinic PLLC
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Baton Rouge, Louisiana, Estados Unidos, 70817
- Woman's Hospital
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Covington, Louisiana, Estados Unidos, 70433
- Women's Cancer Care-Covington
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New Orleans, Louisiana, Estados Unidos, 70121
- Ochsner Medical Center Jefferson
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Maine
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Bangor, Maine, Estados Unidos, 04401
- Eastern Maine Medical Center
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Brewer, Maine, Estados Unidos, 04412
- Lafayette Family Cancer Center-EMMC
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Scarborough, Maine, Estados Unidos, 04074
- MaineHealth Maine Medical Center- Scarborough
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Maryland
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Baltimore, Maryland, Estados Unidos, 21237
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Baltimore, Maryland, Estados Unidos, 21204
- Greater Baltimore Medical Center
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Bel Air, Maryland, Estados Unidos, 21014
- UM Upper Chesapeake Medical Center
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Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center
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Ocean Pines, Maryland, Estados Unidos, 21811
- TidalHealth Richard A Henson Cancer Institute
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Salisbury, Maryland, Estados Unidos, 21801
- TidalHealth Peninsula Regional
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hospital
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Worcester, Massachusetts, Estados Unidos, 01605
- UMass Memorial Medical Center - Memorial Division
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan Rogel Cancer Center
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Ann Arbor, Michigan, Estados Unidos, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Brownstown, Michigan, Estados Unidos, 48183
- Henry Ford Cancer Institute-Downriver
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Clinton Township, Michigan, Estados Unidos, 48038
- Henry Ford Macomb Hospital-Clinton Township
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital
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Detroit, Michigan, Estados Unidos, 48201
- Wayne State University/Karmanos Cancer Institute
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Escanaba, Michigan, Estados Unidos, 49829
- OSF Saint Francis Hospital and Medical Group
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Farmington Hills, Michigan, Estados Unidos, 48334
- Weisberg Cancer Treatment Center
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Grand Rapids, Michigan, Estados Unidos, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Kalamazoo, Michigan, Estados Unidos, 49007
- West Michigan Cancer Center
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Lansing, Michigan, Estados Unidos, 48912
- University of Michigan Health - Sparrow Lansing
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Pontiac, Michigan, Estados Unidos, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
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Traverse City, Michigan, Estados Unidos, 49684
- Munson Medical Center
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West Bloomfield, Michigan, Estados Unidos, 48322
- Henry Ford West Bloomfield Hospital
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Minnesota
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Bemidji, Minnesota, Estados Unidos, 56601
- Sanford Joe Lueken Cancer Center
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Burnsville, Minnesota, Estados Unidos, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, Estados Unidos, 55433
- Mercy Hospital
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Edina, Minnesota, Estados Unidos, 55435
- Fairview Southdale Hospital
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Mankato, Minnesota, Estados Unidos, 56001
- Mayo Clinic Health Systems-Mankato
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Maple Grove, Minnesota, Estados Unidos, 55369
- Fairview Clinics and Surgery Center Maple Grove
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Maplewood, Minnesota, Estados Unidos, 55109
- Saint John's Hospital - Healtheast
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Minneapolis, Minnesota, Estados Unidos, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota/Masonic Cancer Center
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic in Rochester
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Estados Unidos, 55101
- Regions Hospital
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Saint Paul, Minnesota, Estados Unidos, 55102
- United Hospital
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Shakopee, Minnesota, Estados Unidos, 55379
- Saint Francis Regional Medical Center
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Woodbury, Minnesota, Estados Unidos, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216
- University of Mississippi Medical Center
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Missouri
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Cape Girardeau, Missouri, Estados Unidos, 63703
- Saint Francis Medical Center
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Columbia, Missouri, Estados Unidos, 65212
- MU Health - University Hospital/Ellis Fischel Cancer Center
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Joplin, Missouri, Estados Unidos, 64804
- Mercy Hospital Joplin
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Springfield, Missouri, Estados Unidos, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Estados Unidos, 65804
- Mercy Hospital Springfield
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St Louis, Missouri, Estados Unidos, 63110
- Barnes-Jewish Hospital
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St Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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Montana
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Billings, Montana, Estados Unidos, 59101
- Billings Clinic Cancer Center
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Bozeman, Montana, Estados Unidos, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Estados Unidos, 59405
- Benefis Sletten Cancer Institute
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Nebraska
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Grand Island, Nebraska, Estados Unidos, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
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Kearney, Nebraska, Estados Unidos, 68847
- CHI Health Good Samaritan
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Omaha, Nebraska, Estados Unidos, 68114
- Nebraska Methodist Hospital
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Omaha, Nebraska, Estados Unidos, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Estados Unidos, 68130
- Alegent Health Lakeside Hospital
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89106
- Women's Cancer Center of Nevada
-
-
New Hampshire
-
Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
Nashua, New Hampshire, Estados Unidos, 03063
- Dartmouth Cancer Center - Nashua
-
-
New Jersey
-
Camden, New Jersey, Estados Unidos, 08103
- Cooper Hospital University Medical Center
-
Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center
-
Hamilton, New Jersey, Estados Unidos, 08690
- The Cancer Institute of New Jersey Hamilton
-
Morristown, New Jersey, Estados Unidos, 07960
- Morristown Medical Center
-
Neptune City, New Jersey, Estados Unidos, 07753
- Jersey Shore Medical Center
-
New Brunswick, New Jersey, Estados Unidos, 08903
- Rutgers Cancer Institute of New Jersey
-
Somerville, New Jersey, Estados Unidos, 08876
- Robert Wood Johnson University Hospital Somerset
-
Summit, New Jersey, Estados Unidos, 07902
- Overlook Hospital
-
Voorhees Township, New Jersey, Estados Unidos, 08043
- MD Anderson Cancer Center at Cooper-Voorhees
-
-
New Mexico
-
Albuquerque, New Mexico, Estados Unidos, 87106
- Southwest Gynecologic Oncology Associates Inc
-
Albuquerque, New Mexico, Estados Unidos, 87106
- University of New Mexico Cancer Center
-
Las Cruces, New Mexico, Estados Unidos, 88011
- Memorial Medical Center-Las Cruces
-
-
New York
-
Albany, New York, Estados Unidos, 12208
- Women's Cancer Care Associates LLC
-
Brooklyn, New York, Estados Unidos, 11203
- State University of New York Downstate Medical Center
-
Buffalo, New York, Estados Unidos, 14263
- Roswell Park Cancer Institute
-
New York, New York, Estados Unidos, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Rochester, New York, Estados Unidos, 14642
- University of Rochester
-
Stony Brook, New York, Estados Unidos, 11794
- Stony Brook University Medical Center
-
Syracuse, New York, Estados Unidos, 13210
- State University of New York Upstate Medical University
-
The Bronx, New York, Estados Unidos, 10461
- Montefiore Medical Center-Einstein Campus
-
White Plains, New York, Estados Unidos, 10601
- Dickstein Cancer Treatment Center
-
-
North Carolina
-
Asheville, North Carolina, Estados Unidos, 28803
- AdventHealth Infusion Center Asheville
-
Chapel Hill, North Carolina, Estados Unidos, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Clyde, North Carolina, Estados Unidos, 28721
- AdventHealth Infusion Center Haywood
-
Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center
-
Goldsboro, North Carolina, Estados Unidos, 27534
- Southeastern Medical Oncology Center-Goldsboro
-
Hendersonville, North Carolina, Estados Unidos, 28791
- Margaret R Pardee Memorial Hospital
-
Hendersonville, North Carolina, Estados Unidos, 28792
- AdventHealth Hendersonville
-
Jacksonville, North Carolina, Estados Unidos, 28546
- Southeastern Medical Oncology Center-Jacksonville
-
Pinehurst, North Carolina, Estados Unidos, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
-
Raleigh, North Carolina, Estados Unidos, 27609
- Duke Cancer Center Raleigh
-
Wilmington, North Carolina, Estados Unidos, 28401
- Novant Health New Hanover Regional Medical Center
-
Winston-Salem, North Carolina, Estados Unidos, 27157
- Wake Forest University Health Sciences
-
-
North Dakota
-
Bismarck, North Dakota, Estados Unidos, 58501
- Sanford Bismarck Medical Center
-
Fargo, North Dakota, Estados Unidos, 58122
- Sanford Roger Maris Cancer Center
-
Fargo, North Dakota, Estados Unidos, 58122
- Sanford Broadway Medical Center
-
-
Ohio
-
Akron, Ohio, Estados Unidos, 44307
- Cleveland Clinic Akron General
-
Canton, Ohio, Estados Unidos, 44710
- Aultman Health Foundation
-
Centerville, Ohio, Estados Unidos, 45459
- Miami Valley Hospital South
-
Cincinnati, Ohio, Estados Unidos, 45219
- University of Cincinnati Cancer Center-UC Medical Center
-
Cincinnati, Ohio, Estados Unidos, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, Estados Unidos, 45247
- TriHealth Cancer Institute-Westside
-
Cleveland, Ohio, Estados Unidos, 44109
- MetroHealth Medical Center
-
Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Estados Unidos, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Columbus, Ohio, Estados Unidos, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, Estados Unidos, 43210
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, Estados Unidos, 43219
- The Mark H Zangmeister Center
-
Dayton, Ohio, Estados Unidos, 45405
- Grandview Hospital
-
Findlay, Ohio, Estados Unidos, 45840
- Orion Cancer Care
-
Mayfield Heights, Ohio, Estados Unidos, 44124
- Hillcrest Hospital Cancer Center
-
Sylvania, Ohio, Estados Unidos, 43560
- ProMedica Flower Hospital
-
Toledo, Ohio, Estados Unidos, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
West Chester, Ohio, Estados Unidos, 45069
- University of Cincinnati Cancer Center-West Chester
-
Wright-Patterson Air Force Base, Ohio, Estados Unidos, 45433
- Wright-Patterson Medical Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Estados Unidos, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, Estados Unidos, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
-
Tulsa, Oklahoma, Estados Unidos, 74133
- Cancer Treatment Centers of America
-
-
Oregon
-
Bend, Oregon, Estados Unidos, 97701
- Saint Charles Health System
-
Gresham, Oregon, Estados Unidos, 97030
- Legacy Mount Hood Medical Center
-
Portland, Oregon, Estados Unidos, 97210
- Legacy Good Samaritan Hospital and Medical Center
-
Tualatin, Oregon, Estados Unidos, 97062
- Legacy Meridian Park Hospital
-
-
Pennsylvania
-
Abington, Pennsylvania, Estados Unidos, 19001
- Jefferson Abington Hospital
-
Bethlehem, Pennsylvania, Estados Unidos, 18015
- Saint Luke's University Hospital-Bethlehem Campus
-
Bryn Mawr, Pennsylvania, Estados Unidos, 19010
- Bryn Mawr Hospital
-
Danville, Pennsylvania, Estados Unidos, 17822
- Geisinger Medical Center
-
Ephrata, Pennsylvania, Estados Unidos, 17522
- Ephrata Cancer Center
-
Ephrata, Pennsylvania, Estados Unidos, 17522
- Ephrata Community Hospital
-
Gettysburg, Pennsylvania, Estados Unidos, 17325
- Adams Cancer Center
-
Hanover, Pennsylvania, Estados Unidos, 17331
- WellSpan Medical Oncology and Hematology
-
Harrisburg, Pennsylvania, Estados Unidos, 17109
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
-
Lebanon, Pennsylvania, Estados Unidos, 17042
- Sechler Family Cancer Center
-
Lewisburg, Pennsylvania, Estados Unidos, 17837
- Geisinger Medical Oncology-Lewisburg
-
Paoli, Pennsylvania, Estados Unidos, 19301
- Paoli Memorial Hospital
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania/Abramson Cancer Center
-
Pittsburgh, Pennsylvania, Estados Unidos, 15224
- West Penn Hospital
-
Sayre, Pennsylvania, Estados Unidos, 18840
- Guthrie Medical Group PC-Robert Packer Hospital
-
West Reading, Pennsylvania, Estados Unidos, 19611
- Reading Hospital
-
Wexford, Pennsylvania, Estados Unidos, 15090
- Wexford Health and Wellness Pavilion
-
Williamsport, Pennsylvania, Estados Unidos, 17701
- UPMC Susquehanna
-
Willow Grove, Pennsylvania, Estados Unidos, 19090
- Asplundh Cancer Pavilion
-
Wynnewood, Pennsylvania, Estados Unidos, 19096
- Lankenau Medical Center
-
York, Pennsylvania, Estados Unidos, 17403
- WellSpan Health-York Hospital
-
-
Rhode Island
-
Providence, Rhode Island, Estados Unidos, 02905
- Women and Infants Hospital
-
-
South Carolina
-
Anderson, South Carolina, Estados Unidos, 29621
- AnMed Health Cancer Center
-
Gaffney, South Carolina, Estados Unidos, 29341
- Gibbs Cancer Center-Gaffney
-
Greenville, South Carolina, Estados Unidos, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, Estados Unidos, 29601
- Saint Francis Hospital
-
Greer, South Carolina, Estados Unidos, 29651
- Gibbs Cancer Center-Pelham
-
Hilton Head Island, South Carolina, Estados Unidos, 29926-3827
- South Carolina Cancer Specialists PC
-
Spartanburg, South Carolina, Estados Unidos, 29303
- Spartanburg Medical Center
-
Union, South Carolina, Estados Unidos, 29379
- SMC Center for Hematology Oncology Union
-
-
South Dakota
-
Rapid City, South Dakota, Estados Unidos, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Estados Unidos, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Estados Unidos, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls, South Dakota, Estados Unidos, 57104
- Sanford Cancer Center Oncology Clinic
-
-
Tennessee
-
Kingsport, Tennessee, Estados Unidos, 37660
- Ballad Health Cancer Care - Kingsport
-
Kingsport, Tennessee, Estados Unidos, 37660
- Wellmont Holston Valley Hospital and Medical Center
-
Knoxville, Tennessee, Estados Unidos, 37916
- Covenant Health Cancer Centers
-
Knoxville, Tennessee, Estados Unidos, 37932
- Covenant Health Cancer Centers - West
-
Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University/Ingram Cancer Center
-
-
Texas
-
Dallas, Texas, Estados Unidos, 75235
- Parkland Memorial Hospital
-
Dallas, Texas, Estados Unidos, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Houston, Texas, Estados Unidos, 77030
- Houston Methodist Hospital
-
Houston, Texas, Estados Unidos, 77070
- Methodist Willowbrook Hospital
-
Sugar Land, Texas, Estados Unidos, 77479
- Houston Methodist Sugar Land Hospital
-
-
Utah
-
Murray, Utah, Estados Unidos, 84107
- Intermountain Medical Center
-
Salt Lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute/University of Utah
-
Salt Lake City, Utah, Estados Unidos, 84106
- Utah Cancer Specialists-Salt Lake City
-
South Jordan, Utah, Estados Unidos, 84009
- South Jordan Health Center
-
St. George, Utah, Estados Unidos, 84770
- Saint George Regional Medical Center
-
-
Vermont
-
Berlin Corners, Vermont, Estados Unidos, 05602
- Central Vermont Medical Center/National Life Cancer Treatment
-
Burlington, Vermont, Estados Unidos, 05401
- University of Vermont Medical Center
-
Burlington, Vermont, Estados Unidos, 05405
- University of Vermont and State Agricultural College
-
-
Virginia
-
Charlottesville, Virginia, Estados Unidos, 22908
- University of Virginia Cancer Center
-
Richmond, Virginia, Estados Unidos, 23235
- VCU Massey Cancer Center at Stony Point
-
Richmond, Virginia, Estados Unidos, 23298
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Bellingham, Washington, Estados Unidos, 98225
- PeaceHealth Saint Joseph Medical Center
-
Edmonds, Washington, Estados Unidos, 98026
- Swedish Cancer Institute-Edmonds
-
Kennewick, Washington, Estados Unidos, 99336
- Kadlec Clinic Hematology and Oncology
-
Mount Vernon, Washington, Estados Unidos, 98274
- Skagit Valley Hospital
-
Mount Vernon, Washington, Estados Unidos, 98274
- Skagit Regional Health Cancer Care Center
-
Seattle, Washington, Estados Unidos, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, Estados Unidos, 98195
- University of Washington Medical Center - Montlake
-
Seattle, Washington, Estados Unidos, 98104
- Pacific Gynecology Specialists
-
Seattle, Washington, Estados Unidos, 98109
- Fred Hutchinson Cancer Center
-
Seattle, Washington, Estados Unidos, 98133
- University of Washington Medical Center - Northwest
-
Seattle, Washington, Estados Unidos, 98133
- Women's Cancer Center of Seattle
-
Vancouver, Washington, Estados Unidos, 98686
- Legacy Salmon Creek Hospital
-
Wenatchee, Washington, Estados Unidos, 98801
- Wenatchee Valley Hospital and Clinics
-
-
West Virginia
-
Charleston, West Virginia, Estados Unidos, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
-
Huntington, West Virginia, Estados Unidos, 25701
- Edwards Comprehensive Cancer Center
-
Morgantown, West Virginia, Estados Unidos, 26506
- West Virginia University Healthcare
-
Morgantown, West Virginia, Estados Unidos, 26505
- Monongalia Hospital
-
-
Wisconsin
-
Appleton, Wisconsin, Estados Unidos, 54915
- Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
-
Burlington, Wisconsin, Estados Unidos, 53105
- Aurora Cancer Care-Southern Lakes VLCC
-
Chippewa Falls, Wisconsin, Estados Unidos, 54729
- Marshfield Clinic-Chippewa Center
-
Eau Claire, Wisconsin, Estados Unidos, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Fond du Lac, Wisconsin, Estados Unidos, 54937
- Aurora Health Center-Fond du Lac
-
Germantown, Wisconsin, Estados Unidos, 53022
- Aurora Health Care Germantown Health Center
-
Grafton, Wisconsin, Estados Unidos, 53024
- Aurora Cancer Care-Grafton
-
Green Bay, Wisconsin, Estados Unidos, 54311
- Aurora BayCare Medical Center
-
Green Bay, Wisconsin, Estados Unidos, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, Estados Unidos, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Kenosha, Wisconsin, Estados Unidos, 53142
- Aurora Cancer Care-Kenosha South
-
La Crosse, Wisconsin, Estados Unidos, 54601
- Gundersen Lutheran Medical Center
-
Ladysmith, Wisconsin, Estados Unidos, 54848
- Marshfield Medical Center - Ladysmith
-
Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Marinette, Wisconsin, Estados Unidos, 54143
- Aurora Bay Area Medical Group-Marinette
-
Marinette, Wisconsin, Estados Unidos, 54143
- Saint Vincent Hospital Cancer Center at Marinette
-
Marshfield, Wisconsin, Estados Unidos, 54449
- Marshfield Medical Center-Marshfield
-
Mequon, Wisconsin, Estados Unidos, 53097
- Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon
-
Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College of Wisconsin
-
Milwaukee, Wisconsin, Estados Unidos, 53209
- Aurora Cancer Care-Milwaukee
-
Milwaukee, Wisconsin, Estados Unidos, 53215
- Aurora Saint Luke's Medical Center
-
Milwaukee, Wisconsin, Estados Unidos, 53233
- Aurora Sinai Medical Center
-
Milwaukee, Wisconsin, Estados Unidos, 53211
- Ascension Columbia Saint Mary's Hospital-Milwaukee Campus
-
Minocqua, Wisconsin, Estados Unidos, 54548
- Marshfield Medical Center - Minocqua
-
Mukwonago, Wisconsin, Estados Unidos, 53149
- ProHealth D N Greenwald Center
-
Oconomowoc, Wisconsin, Estados Unidos, 53066
- ProHealth Oconomowoc Memorial Hospital
-
Oconto Falls, Wisconsin, Estados Unidos, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Oshkosh, Wisconsin, Estados Unidos, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
-
Oshkosh, Wisconsin, Estados Unidos, 54904
- Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh
-
Racine, Wisconsin, Estados Unidos, 53406
- Aurora Cancer Care-Racine
-
Rice Lake, Wisconsin, Estados Unidos, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, Estados Unidos, 53081
- Vince Lombardi Cancer Clinic-Sheboygan
-
Stevens Point, Wisconsin, Estados Unidos, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Stevens Point, Wisconsin, Estados Unidos, 54481
- Aspirus Cancer Care - Stevens Point
-
Sturgeon Bay, Wisconsin, Estados Unidos, 54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Summit, Wisconsin, Estados Unidos, 53066
- Aurora Medical Center in Summit
-
Two Rivers, Wisconsin, Estados Unidos, 54241
- Vince Lombardi Cancer Clinic-Two Rivers
-
Waukesha, Wisconsin, Estados Unidos, 53188
- UW Cancer Center at ProHealth Care
-
Waukesha, Wisconsin, Estados Unidos, 53188
- ProHealth Waukesha Memorial Hospital
-
Wausau, Wisconsin, Estados Unidos, 54401
- Marshfield Clinic-Wausau Center
-
Wauwatosa, Wisconsin, Estados Unidos, 53226
- Aurora Cancer Care-Milwaukee West
-
West Allis, Wisconsin, Estados Unidos, 53227
- Aurora West Allis Medical Center
-
Weston, Wisconsin, Estados Unidos, 54476
- Marshfield Medical Center - Weston
-
Wisconsin Rapids, Wisconsin, Estados Unidos, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
-
-
-
Osaka, Japón, 589 8511
- Kindai University
-
Saitama, Japón, 350-1298
- Saitama Medical University International Medical Center
-
Tokyo, Japón, 104 0045
- National Cancer Center Hospital
-
-
Ehime
-
Tōon, Ehime, Japón, 791-0295
- Ehime University Hospital
-
-
Hokkaido
-
Sapporo, Hokkaido, Japón, 060-8648
- Hokkaido University Hospital
-
-
Kagoshima-ken
-
Kagoshima, Kagoshima-ken, Japón, 890-8760
- Kagoshima City Hospital
-
-
Tokyo
-
Koto-ku, Tokyo, Japón, 135-8550
- The Cancer Institute Hospital Of JFCR
-
-
-
-
-
San Juan, Puerto Rico, 00927
- Centro Comprensivo de Cancer de UPR
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
-
Patients must have histologically or cytologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer and must have a histological diagnosis of either serous or endometrioid cancer based on local histopathological findings; both endometrioid and serous histology should be high-grade for eligibility of non-mutation carriers; patients with clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma 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 BRCA testing through Myriad, Myriad testing will be accepted; if testing for 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 germ line deleterious BRCA 1 or BRCA 2 mutation or BRCA rearrangement is required (12/05/2016); a copy of Myriad or other BRCA mutational analysis (positive or variants of unknown significance [VUS] or negative) reports will be requested but not required for study enrollment
-
Patients should have recurrent platinum-resistant or- refractory disease - defined as disease that has progressed by imaging while receiving platinum or had recurrence within 6 months of the last receipt of platinum-based chemotherapy; rising CA125 only is not considered as platinum-resistant or refractory disease (12/05/2016)
-
Phase II study: measurable disease by RECIST 1.1 criteria; if archival tumor sample is not available tumor sample from fresh biopsy is acceptable (12/05/2016)
-
Phase III study: evaluable disease - defined as RECIST 1.1 measurable disease OR non-measurable 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 in the setting of a cancer antigen [CA]125 >= 2 x upper limit of normal [ULN])
-
No more than 3 prior treatment regimens (including primary therapy; no more than 1 prior non-platinum based therapy in the platinum-resistant/-refractory setting); hormonal therapies used as single agents (i.e. tamoxifen, aromatase inhibitors) will not count towards this line limit (12/05/2016)
-
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 PARP-inhibitor
-
Patient must have provided study specific informed consent prior to study entry
-
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2
-
Absolute neutrophil count >= 1,500/mcL (12/05/2016)
-
Platelets >= 100,000/mcL (12/05/2016)
-
Hemoglobin >= 10 g/dL (12/05/2016)
-
Total bilirubin within =< 1.5 times the upper limit of normal (ULN) institutional limits (12/05/2016)
-
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN; if intrahepatic liver metastases are present, AST and ALT must be =< 5 times institutional ULN (12/05/2016)
-
Creatinine =< 1.5 x the institutional ULN (12/05/2016)
-
Urine protein: creatinine ratio urine protein creatinine (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 protein of =< 500 mg over 24 hours (12/05/2016)
-
Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the study chair.
-
Adequately controlled blood pressure (systolic blood pressure [SBP] =< 140; diastolic blood pressure [DBP] =< 90 mmHg) on maximum of three antihypertensive medications; 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; it is strongly recommended that patients who are on three antihypertensive medications be followed by a cardiologist or a primary care physician for management of BP 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 cediranib alone and the combination of olaparib and cediranib arms (12/05/2016)
-
Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid-stimulating hormone (TSH) within normal limits (12/05/2016)
-
Able to swallow and retain oral medications and without gastrointestinal (GI) illnesses that would preclude absorption of cediranib or olaparib
-
Age >= 18 years
-
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
-
Olaparib adversely affects embryofetal survival and development in the rat; 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 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 3 months after the last dose of olaparib; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
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 (12/05/2016)
-
Any other investigational agents within the past 4 weeks
-
Prior treatment affecting the VEGF/VEGFR pathway or the angiopoietin pathway in the recurrent setting, including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, pazopanib, cediranib, nintedanib, and trebananib; bevacizumab used in the upfront setting in conjunction with chemotherapy and/or as maintenance to treat newly diagnosed disease will be allowed
-
Prior use of PARP-inhibitors
-
CA-125 only disease without Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable or otherwise evaluable disease
-
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib
-
Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
-
History of intra-abdominal abscess within the past 3 months
-
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 (12/05/2016)
-
Dependency on 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 Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions (12/05/2016)
- Prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence
-
Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should not be included on this study, since neurologic dysfunction may confound the evaluation of neurologic and other adverse events; 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
-
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 functional 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
-
Clinical significant peripheral vascular disease or vascular disease (aortic aneurysm or aortic dissection)
-
Evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted
-
Evidence 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)
-
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
-
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 (12/05/2016)
-
Known human immunodeficiency virus (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
-
Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible
- Strong inhibitors and inducers of UGT/PgP should be used with caution (12/05/2016)
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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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Phase II Arm I (reference regimen)
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016) |
Given IV
Otros nombres:
Undergo CT
Otros nombres:
Undergo MRI
Otros nombres:
Ancillary studies Given IV
Otros nombres:
Given IV
Otros nombres:
Given IV
Otros nombres:
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Experimental: Phase II Arm II (cediranib maleate, olaparib)
Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. |
Undergo CT
Otros nombres:
Undergo MRI
Otros nombres:
Ancillary studies Given PO
Otros nombres:
Given PO
Otros nombres:
Given PO
Otros nombres:
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Experimental: Phase II Arm III (cediranib maleate)
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. |
Undergo CT
Otros nombres:
Undergo MRI
Otros nombres:
Ancillary studies Given PO
Otros nombres:
Given PO
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Experimental: Phase II Arm IV (olaparib)
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen). |
Undergo CT
Otros nombres:
Undergo MRI
Otros nombres:
Ancillary studies Given PO
Otros nombres:
|
|
Comparador activo: Phase III Arm I (reference regimen)
Patients undergo physician's choice standard of care chemotherapy as in Phase II Arm I. No modification of the assigned regimens, such as additional drugs (gemcitabine or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016) |
Given IV
Otros nombres:
Undergo CT
Otros nombres:
Undergo MRI
Otros nombres:
Ancillary studies Given IV
Otros nombres:
Given IV
Otros nombres:
Given IV
Otros nombres:
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|
Experimental: Phase III Arm II (cediranib maleate, olaparib)
Patients receive cediranib maleate PO and olaparib PO as in Phase II Arm II. Patients also undergo CT and MRI throughout the study. |
Undergo CT
Otros nombres:
Undergo MRI
Otros nombres:
Ancillary studies Given PO
Otros nombres:
Given PO
Otros nombres:
Given PO
Otros nombres:
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Experimental: Phase III Arm III (single-agent cediranib maleate)
Patients receive cediranib maleate PO as determined by the Phase II study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. |
Undergo CT
Otros nombres:
Undergo MRI
Otros nombres:
Ancillary studies Given PO
Otros nombres:
Given PO
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Progression-free Survival (PFS) (Phase II Only)
Periodo de tiempo: 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. Approximately 42 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. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
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. Approximately 42 months.
|
|
Progression-free Survival (PFS) (Phase III Only)
Periodo de tiempo: 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. Approximately 42 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. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
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. Approximately 42 months.
|
|
Overall Survival (OS) (Phase III Only)
Periodo de tiempo: Time from study enrollment to death due to any cause, assessed up to 5 years
|
Overall survival will be evaluated. To allow for better understanding of time to subsequent therapy and OS, patients on experimental study drug(s) or standard chemotherapy arm will be followed after progression, with data capture to include the date of initiation of the subsequent therapy, detailed information on the type of subsequent therapy received, and time to progression on the subsequent therapy. |
Time from study enrollment to death due to any cause, assessed up to 5 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Objective Response Rate (Complete Response and Partial Response) (Phase II Only)
Periodo de tiempo: Up to 5 years
|
The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria. A Complete response (CR) is defined as the complete disappearance of all target lesions, while a Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters of target lesions compared to the baseline measurement; essentially, the tumor shrinks significantly but does not completely disappear. Overall response (OR) = CR + PR. |
Up to 5 years
|
|
Objective Response Rate (Complete Response and Partial Response for Phase III Only)
Periodo de tiempo: Up to 5 years
|
The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria. A Complete response (CR) is defined as the complete disappearance of all target lesions, while a Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters of target lesions compared to the baseline measurement; essentially, the tumor shrinks significantly but does not completely disappear. Overall response (OR) = CR + PR. |
Up to 5 years
|
|
Incidence of Grade 3 (or Higher) Adverse Events
Periodo de tiempo: Up to 5 years
|
Adverse events will be categorized by CTCAE V4.0. This outcome will report the count of participants who experienced a grade 3 (or higher) adverse event. |
Up to 5 years
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient-reported Scores of Disease-related Symptoms
Periodo de tiempo: Up to 5 years
|
Measured by the 9-item Disease Related Symptoms (DRS-9) subscale of the National Comprehensive Cancer Network (NCCN)-Functional Assessment of Cancer Therapy (FACT) Ovarian Symptom Index (NFOSI-18). |
Up to 5 years
|
|
Gene Mutations Assessed BROCA-HR
Periodo de tiempo: Up to 5 years
|
A single proportional hazards model will be used to estimate the treatment hazard ratios (and variances) for each of the experimental treatments selected for phase III evaluation relative to the reference treatment (chemotherapy) group. The model will include adjustments for prior platinum-free interval, prior bevacizumab treatment, age at study enrollment, randomly assigned study treatment and BROCA-HR status. The estimated hazard ratio(s) for BROCA-HR and the corresponding confidence intervals will be depicted with a forest plot, and assessed for qualitative interaction(s). |
Up to 5 years
|
|
Change in Circulating Endothelial Cell Levels
Periodo de tiempo: Baseline up to 5 years
|
A proportional hazards model will be used to assess a linear association between the change in circulating endothelial cell values and the log relative hazard of death within each treatment group. Sensitivity analyses will include known prognostic factors in the model. A plot of the martingale residuals or estimated relative hazards by change in circulating endothelial cell quintiles will be used to qualitatively assess the assumption of a linear relationship between the change in circulating endothelial cell values and the log relative hazard. |
Baseline up to 5 years
|
|
Biomarkers in Plasma Angiome
Periodo de tiempo: Up to 5 years
|
A proportional hazards model will be used to assess whether the pretreatment values of any of these analytes have a prognostic association with overall survival. The model will include clinical covariates: age, performance status, and the randomly assigned study treatment. Proportional hazards models will be used to assess the relationship between patients' analyte values and log hazard. A proportional hazards model will be used to assess the potential predictive associations between analytes, treatment and survival. |
Up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jung-min Lee, NRG Oncology
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimado)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema endocrino
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades Genitales Femeninas
- Neoplasias de glándulas endocrinas
- Enfermedades Ováricas
- Enfermedades anexiales
- Neoplasias Genitales Femeninas
- Trastornos gonadales
- Enfermedades de las trompas de Falopio
- Neoplasias Ováricas
- Neoplasias de las trompas de Falopio
- Químicos orgánicos
- Compuestos heterocíclicos
- Técnicas de investigación
- Hidrocarburos
- Cicloparafinas
- Hidrocarburos, alicíclicos
- Hidrocarburos, cíclico
- Terpenos
- Carbohidratos
- Campeptecina
- Alcaloides
- Hidrocarburos aromáticos policíclicos
- Hidrocarburos, aromáticos
- Compuestos policíclicos
- Glucósidos
- Taxaides
- Ciclodecanos
- Diterpenos
- Economía y organizaciones de la atención médica
- Técnicas de química, analítica
- Análisis de espectro
- Antraciclinas
- Naftacenos
- Aminoglucósidos
- Daunorrubicina
- Ciencias económicas
- Doxorrubicina
- Paclitaxel
- Topotecán
- Espectroscopía de resonancia magnética
- doxorrubicina liposomal
- olaparib
- cediranib
- Impuestos
Otros números de identificación del estudio
- NCI-2015-00651
- U10CA180868 (Subvención/contrato del NIH de EE. UU.)
- NCI-2015-00651 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- NRG-GY005 (Otro identificador: CTEP)
- s16-01681
- NRG-GY005
- NRG-GY005 (Otro identificador: NRG Oncology)
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