Test af kombinationen af Cediranib og Olaparib i sammenligning med hvert enkelt lægemiddel alene eller anden kemoterapi ved tilbagevendende platinresistent ovariecancer
Et randomiseret fase II/III-studie af kombinationen af Cediranib og Olaparib sammenlignet med Cediranib eller Olaparib alene, eller standardbehandling kemoterapi hos kvinder med tilbagevendende platin-resistent eller refraktær ovarie-, æggeleder- eller primær peritoneal cancer (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.
Studieoversigt
Status
Betingelser
- Tilbagevendende æggelederkarcinom
- Tilbagevendende ovariekarcinom
- Tilbagevendende primært peritonealt karcinom
- Ovarial Endometrioid Adenocarcinom
- Ovarial seromucinøst karcinom
- Ovarialt udifferentieret karcinom
- Ovarial klarcellet adenokarcinom
- Overgangscellekarcinom i æggelederen
- Ovarialt overgangscellekarcinom
- Klarcellet adenokarcinom i æggelederen
- Æggeleder endometrioid adenokarcinom
- Serøst adenokarcinom i æggelederen
- Æggelederudifferentieret karcinom
- Serøst adenokarcinom i æggestokkene
- Primært peritonealt serøst adenokarcinom
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiesteder
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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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Barrie, Ontario, Canada, L4M 6M2
- Royal Victoria Regional Health Centre
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre at Hamilton Health Sciences
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Kingston, Ontario, Canada, K7L 2V7
- Kingston Health Sciences Centre
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London, Ontario, Canada, N6A 4L6
- London Regional Cancer Program
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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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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- University of Alabama at Birmingham Cancer Center
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, Forenede Stater, 99508
- Providence Alaska Medical Center
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- University of Arkansas for Medical Sciences
-
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California
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Auburn, California, Forenede Stater, 95602
- Sutter Auburn Faith Hospital
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Berkeley, California, Forenede Stater, 94704
- Alta Bates Summit Medical Center-Herrick Campus
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Carmichael, California, Forenede Stater, 95608
- Mercy San Juan Medical Center
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Elk Grove, California, Forenede Stater, 95758
- Mercy Cancer Center - Elk Grove
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Greenbrae, California, Forenede Stater, 94904
- Marin Cancer Care Inc
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La Jolla, California, Forenede Stater, 92093
- UC San Diego Moores Cancer Center
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Mountain View, California, Forenede Stater, 94040
- Palo Alto Medical Foundation-Camino Division
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Mountain View, California, Forenede Stater, 94040
- Palo Alto Medical Foundation-Gynecologic Oncology
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Oakland, California, Forenede Stater, 94611
- Kaiser Permanente-Oakland
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Palo Alto, California, Forenede Stater, 94301
- Palo Alto Medical Foundation Health Care
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Rocklin, California, Forenede Stater, 95765
- Mercy Cancer Center - Rocklin
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Roseville, California, Forenede Stater, 95661
- Sutter Roseville Medical Center
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Sacramento, California, Forenede Stater, 95816
- Sutter Medical Center Sacramento
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Comprehensive Cancer Center
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Sacramento, California, Forenede Stater, 95814
- Kaiser Permanente Downtown Commons
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Sacramento, California, Forenede Stater, 95825
- Kaiser Permanente Sacramento Medical Center
-
Sacramento, California, Forenede Stater, 95816
- Mercy Cancer Center - Sacramento
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San Francisco, California, Forenede Stater, 94115
- Kaiser Permanente-San Francisco
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San Francisco, California, Forenede Stater, 94158
- UCSF Medical Center-Mission Bay
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San Francisco, California, Forenede Stater, 94115
- California Pacific Medical Center-Pacific Campus
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San Luis Obispo, California, Forenede Stater, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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Santa Clara, California, Forenede Stater, 95051
- Kaiser Permanente Medical Center - Santa Clara
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Santa Cruz, California, Forenede Stater, 95065
- Palo Alto Medical Foundation-Santa Cruz
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Santa Rosa, California, Forenede Stater, 95403
- Sutter Pacific Medical Foundation
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Sunnyvale, California, Forenede Stater, 94086
- Palo Alto Medical Foundation-Sunnyvale
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Vallejo, California, Forenede Stater, 94589
- Kaiser Permanente-Vallejo
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Walnut Creek, California, Forenede Stater, 94596
- Kaiser Permanente-Walnut Creek
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Woodland, California, Forenede Stater, 95695
- Woodland Memorial Hospital
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- UCHealth University of Colorado Hospital
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Colorado Springs, Colorado, Forenede Stater, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Forenede Stater, 80909
- UCHealth Memorial Hospital Central
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Denver, Colorado, Forenede Stater, 80205
- Kaiser Permanente-Franklin
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Denver, Colorado, Forenede Stater, 80220
- Rocky Mountain Cancer Centers-Rose
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Fort Collins, Colorado, Forenede Stater, 80524
- Poudre Valley Hospital
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Highlands Ranch, Colorado, Forenede Stater, 80129
- UCHealth Highlands Ranch Hospital
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Lafayette, Colorado, Forenede Stater, 80026
- Kaiser Permanente-Rock Creek
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Lone Tree, Colorado, Forenede Stater, 80124
- Kaiser Permanente-Lone Tree
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Connecticut
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Danbury, Connecticut, Forenede Stater, 06810
- Danbury Hospital
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Fairfield, Connecticut, Forenede Stater, 06824
- Smilow Cancer Hospital Care Center-Fairfield
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Hartford, Connecticut, Forenede Stater, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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Hartford, Connecticut, Forenede Stater, 06102
- Hartford Hospital
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Middletown, Connecticut, Forenede Stater, 06457
- Middlesex Hospital
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New Britain, Connecticut, Forenede Stater, 06050
- The Hospital of Central Connecticut
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New Haven, Connecticut, Forenede Stater, 06520
- Yale University
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Norwalk, Connecticut, Forenede Stater, 06856
- Norwalk Hospital
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Trumbull, Connecticut, Forenede Stater, 06611
- Smilow Cancer Hospital Care Center-Trumbull
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Delaware
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Newark, Delaware, Forenede Stater, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Forenede Stater, 19713
- Medical Oncology Hematology Consultants PA
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Newark, Delaware, Forenede Stater, 19718
- Christiana Care Health System-Christiana Hospital
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20016
- Sibley Memorial Hospital
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Florida
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Gainesville, Florida, Forenede Stater, 32610
- UF Health Cancer Institute - Gainesville
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Miami Beach, Florida, Forenede Stater, 33140
- Mount Sinai Medical Center
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Orlando, Florida, Forenede Stater, 32806
- Orlando Health Cancer Institute
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Sarasota, Florida, Forenede Stater, 34239
- Sarasota Memorial Hospital
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Georgia
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Atlanta, Georgia, Forenede Stater, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Forenede Stater, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, Forenede Stater, 30309
- Piedmont Hospital
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Atlanta, Georgia, Forenede Stater, 30342
- Northside Hospital
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Augusta, Georgia, Forenede Stater, 30912
- Augusta University Medical Center
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Austell, Georgia, Forenede Stater, 30106
- WellStar Cobb Hospital
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Marietta, Georgia, Forenede Stater, 30060
- Wellstar Kennestone Hospital
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Marietta, Georgia, Forenede Stater, 30060
- WellStar Health System Inc
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Roswell, Georgia, Forenede Stater, 30076
- WellStar North Fulton Hospital
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Savannah, Georgia, Forenede Stater, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Savannah, Georgia, Forenede Stater, 31404
- Memorial Health University Medical Center
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Smyrna, Georgia, Forenede Stater, 30080
- WellStar Vinings Health Park
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- Queen's Medical Center
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Honolulu, Hawaii, Forenede Stater, 96826
- Kapiolani Medical Center for Women and Children
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Idaho
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Boise, Idaho, Forenede Stater, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Forenede Stater, 83712
- Saint Luke's Cancer Institute - Boise
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Fruitland, Idaho, Forenede Stater, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Forenede Stater, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Forenede Stater, 83687
- Saint Luke's Cancer Institute - Nampa
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Illinois
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Aurora, Illinois, Forenede Stater, 60504
- Rush-Copley Medical Center
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Bloomington, Illinois, Forenede Stater, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Forenede Stater, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Forenede Stater, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Forenede Stater, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
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Chicago, Illinois, Forenede Stater, 60612
- John H Stroger Jr Hospital of Cook County
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Chicago, Illinois, Forenede Stater, 60657
- UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
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Chicago, Illinois, Forenede Stater, 60612
- Rush MD Anderson Cancer Center
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Decatur, Illinois, Forenede Stater, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Forenede Stater, 62526
- Cancer Care Specialists of Illinois - Decatur
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Effingham, Illinois, Forenede Stater, 62401
- Crossroads Cancer Center
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Eureka, Illinois, Forenede Stater, 61530
- Illinois CancerCare-Eureka
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Evanston, Illinois, Forenede Stater, 60201
- NorthShore University HealthSystem-Evanston Hospital
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Galesburg, Illinois, Forenede Stater, 61401
- Illinois CancerCare-Galesburg
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Geneva, Illinois, Forenede Stater, 60134
- Northwestern Medicine Cancer Center Delnor
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Glenview, Illinois, Forenede Stater, 60026
- NorthShore University HealthSystem-Glenbrook Hospital
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Highland Park, Illinois, Forenede Stater, 60035
- NorthShore University HealthSystem-Highland Park Hospital
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Hinsdale, Illinois, Forenede Stater, 60521
- Sudarshan K Sharma MD Limited-Gynecologic Oncology
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Kewanee, Illinois, Forenede Stater, 61443
- Illinois CancerCare-Kewanee Clinic
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Macomb, Illinois, Forenede Stater, 61455
- Illinois CancerCare-Macomb
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O'Fallon, Illinois, Forenede Stater, 62269
- Cancer Care Center of O'Fallon
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Ottawa, Illinois, Forenede Stater, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Forenede Stater, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Forenede Stater, 61615
- Illinois CancerCare-Peoria
-
Peru, Illinois, Forenede Stater, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, Forenede Stater, 61356
- Illinois CancerCare-Princeton
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Springfield, Illinois, Forenede Stater, 62702
- Springfield Clinic
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Springfield, Illinois, Forenede Stater, 62781
- Springfield Memorial Hospital
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Warrenville, Illinois, Forenede Stater, 60555
- Northwestern Medicine Cancer Center Warrenville
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Zion, Illinois, Forenede Stater, 60099
- Midwestern Regional Medical Center
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46845
- Parkview Regional Medical Center
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, Forenede Stater, 46260
- Ascension Saint Vincent Indianapolis Hospital
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Richmond, Indiana, Forenede Stater, 47374
- Reid Health
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South Bend, Indiana, Forenede Stater, 46601
- Memorial Hospital of South Bend
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Iowa
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Clive, Iowa, Forenede Stater, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Forenede Stater, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Des Moines, Iowa, Forenede Stater, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, Forenede Stater, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Forenede Stater, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
-
Des Moines, Iowa, Forenede Stater, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa/Holden Comprehensive Cancer Center
-
Sioux City, Iowa, Forenede Stater, 51101
- Siouxland Regional Cancer Center
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West Des Moines, Iowa, Forenede Stater, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Wichita, Kansas, Forenede Stater, 67214
- Ascension Via Christi Hospitals Wichita
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Wichita, Kansas, Forenede Stater, 67208
- Associates In Womens Health
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Kentucky
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Edgewood, Kentucky, Forenede Stater, 41017
- Saint Elizabeth Healthcare Edgewood
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Lexington, Kentucky, Forenede Stater, 40536
- University of Kentucky/Markey Cancer Center
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Mary Bird Perkins Cancer Center
-
Baton Rouge, Louisiana, Forenede Stater, 70809
- Hematology/Oncology Clinic PLLC
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Baton Rouge, Louisiana, Forenede Stater, 70817
- Woman's Hospital
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Covington, Louisiana, Forenede Stater, 70433
- Women's Cancer Care-Covington
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New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Medical Center Jefferson
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Maine
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Bangor, Maine, Forenede Stater, 04401
- Eastern Maine Medical Center
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Brewer, Maine, Forenede Stater, 04412
- Lafayette Family Cancer Center-EMMC
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Scarborough, Maine, Forenede Stater, 04074
- MaineHealth Maine Medical Center- Scarborough
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Maryland
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Baltimore, Maryland, Forenede Stater, 21237
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Baltimore, Maryland, Forenede Stater, 21204
- Greater Baltimore Medical Center
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Bel Air, Maryland, Forenede Stater, 21014
- UM Upper Chesapeake Medical Center
-
Bethesda, Maryland, Forenede Stater, 20892
- National Institutes of Health Clinical Center
-
Ocean Pines, Maryland, Forenede Stater, 21811
- TidalHealth Richard A Henson Cancer Institute
-
Salisbury, Maryland, Forenede Stater, 21801
- TidalHealth Peninsula Regional
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Forenede Stater, 02115
- Brigham and Women's Hospital
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Worcester, Massachusetts, Forenede Stater, 01605
- UMass Memorial Medical Center - Memorial Division
-
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Rogel Cancer Center
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Ann Arbor, Michigan, Forenede Stater, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Brownstown, Michigan, Forenede Stater, 48183
- Henry Ford Cancer Institute-Downriver
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Clinton Township, Michigan, Forenede Stater, 48038
- Henry Ford Macomb Hospital-Clinton Township
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
-
Detroit, Michigan, Forenede Stater, 48201
- Wayne State University/Karmanos Cancer Institute
-
Escanaba, Michigan, Forenede Stater, 49829
- OSF Saint Francis Hospital and Medical Group
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Farmington Hills, Michigan, Forenede Stater, 48334
- Weisberg Cancer Treatment Center
-
Grand Rapids, Michigan, Forenede Stater, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Kalamazoo, Michigan, Forenede Stater, 49007
- West Michigan Cancer Center
-
Lansing, Michigan, Forenede Stater, 48912
- University of Michigan Health - Sparrow Lansing
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Pontiac, Michigan, Forenede Stater, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
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West Bloomfield, Michigan, Forenede Stater, 48322
- Henry Ford West Bloomfield Hospital
-
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Minnesota
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Bemidji, Minnesota, Forenede Stater, 56601
- Sanford Joe Lueken Cancer Center
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Burnsville, Minnesota, Forenede Stater, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy Hospital
-
Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
-
Mankato, Minnesota, Forenede Stater, 56001
- Mayo Clinic Health Systems-Mankato
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Maple Grove, Minnesota, Forenede Stater, 55369
- Fairview Clinics and Surgery Center Maple Grove
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Maplewood, Minnesota, Forenede Stater, 55109
- Saint John's Hospital - Healtheast
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Minneapolis, Minnesota, Forenede Stater, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota/Masonic Cancer Center
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic in Rochester
-
Saint Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul, Minnesota, Forenede Stater, 55101
- Regions Hospital
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Saint Paul, Minnesota, Forenede Stater, 55102
- United Hospital
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Shakopee, Minnesota, Forenede Stater, 55379
- Saint Francis Regional Medical Center
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Woodbury, Minnesota, Forenede Stater, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216
- University of Mississippi Medical Center
-
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Missouri
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Cape Girardeau, Missouri, Forenede Stater, 63703
- Saint Francis Medical Center
-
Columbia, Missouri, Forenede Stater, 65212
- MU Health - University Hospital/Ellis Fischel Cancer Center
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Joplin, Missouri, Forenede Stater, 64804
- Mercy Hospital Joplin
-
Springfield, Missouri, Forenede Stater, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Forenede Stater, 65804
- Mercy Hospital Springfield
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St Louis, Missouri, Forenede Stater, 63110
- Barnes-Jewish Hospital
-
St Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
-
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Montana
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Billings, Montana, Forenede Stater, 59101
- Billings Clinic Cancer Center
-
Bozeman, Montana, Forenede Stater, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Forenede Stater, 59405
- Benefis Sletten Cancer Institute
-
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Nebraska
-
Grand Island, Nebraska, Forenede Stater, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
-
Kearney, Nebraska, Forenede Stater, 68847
- CHI Health Good Samaritan
-
Omaha, Nebraska, Forenede Stater, 68114
- Nebraska Methodist Hospital
-
Omaha, Nebraska, Forenede Stater, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Forenede Stater, 68130
- Alegent Health Lakeside Hospital
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89106
- Women's Cancer Center of Nevada
-
-
New Hampshire
-
Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
Nashua, New Hampshire, Forenede Stater, 03063
- Dartmouth Cancer Center - Nashua
-
-
New Jersey
-
Camden, New Jersey, Forenede Stater, 08103
- Cooper Hospital University Medical Center
-
Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center
-
Hamilton, New Jersey, Forenede Stater, 08690
- The Cancer Institute of New Jersey Hamilton
-
Morristown, New Jersey, Forenede Stater, 07960
- Morristown Medical Center
-
Neptune City, New Jersey, Forenede Stater, 07753
- Jersey Shore Medical Center
-
New Brunswick, New Jersey, Forenede Stater, 08903
- Rutgers Cancer Institute of New Jersey
-
Somerville, New Jersey, Forenede Stater, 08876
- Robert Wood Johnson University Hospital Somerset
-
Summit, New Jersey, Forenede Stater, 07902
- Overlook Hospital
-
Voorhees Township, New Jersey, Forenede Stater, 08043
- MD Anderson Cancer Center at Cooper-Voorhees
-
-
New Mexico
-
Albuquerque, New Mexico, Forenede Stater, 87106
- Southwest Gynecologic Oncology Associates Inc
-
Albuquerque, New Mexico, Forenede Stater, 87106
- University of New Mexico Cancer Center
-
Las Cruces, New Mexico, Forenede Stater, 88011
- Memorial Medical Center-Las Cruces
-
-
New York
-
Albany, New York, Forenede Stater, 12208
- Women's Cancer Care Associates LLC
-
Brooklyn, New York, Forenede Stater, 11203
- State University of New York Downstate Medical Center
-
Buffalo, New York, Forenede Stater, 14263
- Roswell Park Cancer Institute
-
New York, New York, Forenede Stater, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
-
Rochester, New York, Forenede Stater, 14642
- University of Rochester
-
Stony Brook, New York, Forenede Stater, 11794
- Stony Brook University Medical Center
-
Syracuse, New York, Forenede Stater, 13210
- State University of New York Upstate Medical University
-
The Bronx, New York, Forenede Stater, 10461
- Montefiore Medical Center-Einstein Campus
-
White Plains, New York, Forenede Stater, 10601
- Dickstein Cancer Treatment Center
-
-
North Carolina
-
Asheville, North Carolina, Forenede Stater, 28803
- AdventHealth Infusion Center Asheville
-
Chapel Hill, North Carolina, Forenede Stater, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Clyde, North Carolina, Forenede Stater, 28721
- AdventHealth Infusion Center Haywood
-
Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
-
Goldsboro, North Carolina, Forenede Stater, 27534
- Southeastern Medical Oncology Center-Goldsboro
-
Hendersonville, North Carolina, Forenede Stater, 28791
- Margaret R Pardee Memorial Hospital
-
Hendersonville, North Carolina, Forenede Stater, 28792
- AdventHealth Hendersonville
-
Jacksonville, North Carolina, Forenede Stater, 28546
- Southeastern Medical Oncology Center-Jacksonville
-
Pinehurst, North Carolina, Forenede Stater, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
-
Raleigh, North Carolina, Forenede Stater, 27609
- Duke Cancer Center Raleigh
-
Wilmington, North Carolina, Forenede Stater, 28401
- Novant Health New Hanover Regional Medical Center
-
Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest University Health Sciences
-
-
North Dakota
-
Bismarck, North Dakota, Forenede Stater, 58501
- Sanford Bismarck Medical Center
-
Fargo, North Dakota, Forenede Stater, 58122
- Sanford Roger Maris Cancer Center
-
Fargo, North Dakota, Forenede Stater, 58122
- Sanford Broadway Medical Center
-
-
Ohio
-
Akron, Ohio, Forenede Stater, 44307
- Cleveland Clinic Akron General
-
Canton, Ohio, Forenede Stater, 44710
- Aultman Health Foundation
-
Centerville, Ohio, Forenede Stater, 45459
- Miami Valley Hospital South
-
Cincinnati, Ohio, Forenede Stater, 45219
- University of Cincinnati Cancer Center-UC Medical Center
-
Cincinnati, Ohio, Forenede Stater, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, Forenede Stater, 45247
- TriHealth Cancer Institute-Westside
-
Cleveland, Ohio, Forenede Stater, 44109
- MetroHealth Medical Center
-
Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Forenede Stater, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Columbus, Ohio, Forenede Stater, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, Forenede Stater, 43210
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, Forenede Stater, 43219
- The Mark H Zangmeister Center
-
Dayton, Ohio, Forenede Stater, 45405
- Grandview Hospital
-
Findlay, Ohio, Forenede Stater, 45840
- Orion Cancer Care
-
Mayfield Heights, Ohio, Forenede Stater, 44124
- Hillcrest Hospital Cancer Center
-
Sylvania, Ohio, Forenede Stater, 43560
- ProMedica Flower Hospital
-
Toledo, Ohio, Forenede Stater, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
West Chester, Ohio, Forenede Stater, 45069
- University of Cincinnati Cancer Center-West Chester
-
Wright-Patterson Air Force Base, Ohio, Forenede Stater, 45433
- Wright-Patterson Medical Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, Forenede Stater, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
-
Tulsa, Oklahoma, Forenede Stater, 74133
- Cancer Treatment Centers of America
-
-
Oregon
-
Bend, Oregon, Forenede Stater, 97701
- Saint Charles Health System
-
Gresham, Oregon, Forenede Stater, 97030
- Legacy Mount Hood Medical Center
-
Portland, Oregon, Forenede Stater, 97210
- Legacy Good Samaritan Hospital and Medical Center
-
Tualatin, Oregon, Forenede Stater, 97062
- Legacy Meridian Park Hospital
-
-
Pennsylvania
-
Abington, Pennsylvania, Forenede Stater, 19001
- Jefferson Abington Hospital
-
Bethlehem, Pennsylvania, Forenede Stater, 18015
- Saint Luke's University Hospital-Bethlehem Campus
-
Bryn Mawr, Pennsylvania, Forenede Stater, 19010
- Bryn Mawr Hospital
-
Danville, Pennsylvania, Forenede Stater, 17822
- Geisinger Medical Center
-
Ephrata, Pennsylvania, Forenede Stater, 17522
- Ephrata Cancer Center
-
Ephrata, Pennsylvania, Forenede Stater, 17522
- Ephrata Community Hospital
-
Gettysburg, Pennsylvania, Forenede Stater, 17325
- Adams Cancer Center
-
Hanover, Pennsylvania, Forenede Stater, 17331
- WellSpan Medical Oncology and Hematology
-
Harrisburg, Pennsylvania, Forenede Stater, 17109
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
-
Lebanon, Pennsylvania, Forenede Stater, 17042
- Sechler Family Cancer Center
-
Lewisburg, Pennsylvania, Forenede Stater, 17837
- Geisinger Medical Oncology-Lewisburg
-
Paoli, Pennsylvania, Forenede Stater, 19301
- Paoli Memorial Hospital
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania/Abramson Cancer Center
-
Pittsburgh, Pennsylvania, Forenede Stater, 15224
- West Penn Hospital
-
Sayre, Pennsylvania, Forenede Stater, 18840
- Guthrie Medical Group PC-Robert Packer Hospital
-
West Reading, Pennsylvania, Forenede Stater, 19611
- Reading Hospital
-
Wexford, Pennsylvania, Forenede Stater, 15090
- Wexford Health and Wellness Pavilion
-
Williamsport, Pennsylvania, Forenede Stater, 17701
- UPMC Susquehanna
-
Willow Grove, Pennsylvania, Forenede Stater, 19090
- Asplundh Cancer Pavilion
-
Wynnewood, Pennsylvania, Forenede Stater, 19096
- Lankenau Medical Center
-
York, Pennsylvania, Forenede Stater, 17403
- WellSpan Health-York Hospital
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater, 02905
- Women and Infants Hospital
-
-
South Carolina
-
Anderson, South Carolina, Forenede Stater, 29621
- AnMed Health Cancer Center
-
Gaffney, South Carolina, Forenede Stater, 29341
- Gibbs Cancer Center-Gaffney
-
Greenville, South Carolina, Forenede Stater, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, Forenede Stater, 29601
- Saint Francis Hospital
-
Greer, South Carolina, Forenede Stater, 29651
- Gibbs Cancer Center-Pelham
-
Hilton Head Island, South Carolina, Forenede Stater, 29926-3827
- South Carolina Cancer Specialists PC
-
Spartanburg, South Carolina, Forenede Stater, 29303
- Spartanburg Medical Center
-
Union, South Carolina, Forenede Stater, 29379
- SMC Center for Hematology Oncology Union
-
-
South Dakota
-
Rapid City, South Dakota, Forenede Stater, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Forenede Stater, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls, South Dakota, Forenede Stater, 57104
- Sanford Cancer Center Oncology Clinic
-
-
Tennessee
-
Kingsport, Tennessee, Forenede Stater, 37660
- Ballad Health Cancer Care - Kingsport
-
Kingsport, Tennessee, Forenede Stater, 37660
- Wellmont Holston Valley Hospital and Medical Center
-
Knoxville, Tennessee, Forenede Stater, 37916
- Covenant Health Cancer Centers
-
Knoxville, Tennessee, Forenede Stater, 37932
- Covenant Health Cancer Centers - West
-
Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University/Ingram Cancer Center
-
-
Texas
-
Dallas, Texas, Forenede Stater, 75235
- Parkland Memorial Hospital
-
Dallas, Texas, Forenede Stater, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Houston, Texas, Forenede Stater, 77030
- Houston Methodist Hospital
-
Houston, Texas, Forenede Stater, 77070
- Methodist Willowbrook Hospital
-
Sugar Land, Texas, Forenede Stater, 77479
- Houston Methodist Sugar Land Hospital
-
-
Utah
-
Murray, Utah, Forenede Stater, 84107
- Intermountain Medical Center
-
Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute/University of Utah
-
Salt Lake City, Utah, Forenede Stater, 84106
- Utah Cancer Specialists-Salt Lake City
-
South Jordan, Utah, Forenede Stater, 84009
- South Jordan Health Center
-
St. George, Utah, Forenede Stater, 84770
- Saint George Regional Medical Center
-
-
Vermont
-
Berlin Corners, Vermont, Forenede Stater, 05602
- Central Vermont Medical Center/National Life Cancer Treatment
-
Burlington, Vermont, Forenede Stater, 05401
- University of Vermont Medical Center
-
Burlington, Vermont, Forenede Stater, 05405
- University of Vermont and State Agricultural College
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia Cancer Center
-
Richmond, Virginia, Forenede Stater, 23235
- VCU Massey Cancer Center at Stony Point
-
Richmond, Virginia, Forenede Stater, 23298
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Bellingham, Washington, Forenede Stater, 98225
- PeaceHealth Saint Joseph Medical Center
-
Edmonds, Washington, Forenede Stater, 98026
- Swedish Cancer Institute-Edmonds
-
Kennewick, Washington, Forenede Stater, 99336
- Kadlec Clinic Hematology and Oncology
-
Mount Vernon, Washington, Forenede Stater, 98274
- Skagit Valley Hospital
-
Mount Vernon, Washington, Forenede Stater, 98274
- Skagit Regional Health Cancer Care Center
-
Seattle, Washington, Forenede Stater, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, Forenede Stater, 98195
- University of Washington Medical Center - Montlake
-
Seattle, Washington, Forenede Stater, 98104
- Pacific Gynecology Specialists
-
Seattle, Washington, Forenede Stater, 98109
- Fred Hutchinson Cancer Center
-
Seattle, Washington, Forenede Stater, 98133
- University of Washington Medical Center - Northwest
-
Seattle, Washington, Forenede Stater, 98133
- Women's Cancer Center of Seattle
-
Vancouver, Washington, Forenede Stater, 98686
- Legacy Salmon Creek Hospital
-
Wenatchee, Washington, Forenede Stater, 98801
- Wenatchee Valley Hospital and Clinics
-
-
West Virginia
-
Charleston, West Virginia, Forenede Stater, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
-
Huntington, West Virginia, Forenede Stater, 25701
- Edwards Comprehensive Cancer Center
-
Morgantown, West Virginia, Forenede Stater, 26506
- West Virginia University Healthcare
-
Morgantown, West Virginia, Forenede Stater, 26505
- Monongalia Hospital
-
-
Wisconsin
-
Appleton, Wisconsin, Forenede Stater, 54915
- Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
-
Burlington, Wisconsin, Forenede Stater, 53105
- Aurora Cancer Care-Southern Lakes VLCC
-
Chippewa Falls, Wisconsin, Forenede Stater, 54729
- Marshfield Clinic-Chippewa Center
-
Eau Claire, Wisconsin, Forenede Stater, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Fond du Lac, Wisconsin, Forenede Stater, 54937
- Aurora Health Center-Fond du Lac
-
Germantown, Wisconsin, Forenede Stater, 53022
- Aurora Health Care Germantown Health Center
-
Grafton, Wisconsin, Forenede Stater, 53024
- Aurora Cancer Care-Grafton
-
Green Bay, Wisconsin, Forenede Stater, 54311
- Aurora BayCare Medical Center
-
Green Bay, Wisconsin, Forenede Stater, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, Forenede Stater, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Kenosha, Wisconsin, Forenede Stater, 53142
- Aurora Cancer Care-Kenosha South
-
La Crosse, Wisconsin, Forenede Stater, 54601
- Gundersen Lutheran Medical Center
-
Ladysmith, Wisconsin, Forenede Stater, 54848
- Marshfield Medical Center - Ladysmith
-
Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Marinette, Wisconsin, Forenede Stater, 54143
- Aurora Bay Area Medical Group-Marinette
-
Marinette, Wisconsin, Forenede Stater, 54143
- Saint Vincent Hospital Cancer Center at Marinette
-
Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Medical Center-Marshfield
-
Mequon, Wisconsin, Forenede Stater, 53097
- Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53209
- Aurora Cancer Care-Milwaukee
-
Milwaukee, Wisconsin, Forenede Stater, 53215
- Aurora Saint Luke's Medical Center
-
Milwaukee, Wisconsin, Forenede Stater, 53233
- Aurora Sinai Medical Center
-
Milwaukee, Wisconsin, Forenede Stater, 53211
- Ascension Columbia Saint Mary's Hospital-Milwaukee Campus
-
Minocqua, Wisconsin, Forenede Stater, 54548
- Marshfield Medical Center - Minocqua
-
Mukwonago, Wisconsin, Forenede Stater, 53149
- ProHealth D N Greenwald Center
-
Oconomowoc, Wisconsin, Forenede Stater, 53066
- ProHealth Oconomowoc Memorial Hospital
-
Oconto Falls, Wisconsin, Forenede Stater, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Oshkosh, Wisconsin, Forenede Stater, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
-
Oshkosh, Wisconsin, Forenede Stater, 54904
- Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh
-
Racine, Wisconsin, Forenede Stater, 53406
- Aurora Cancer Care-Racine
-
Rice Lake, Wisconsin, Forenede Stater, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, Forenede Stater, 53081
- Vince Lombardi Cancer Clinic-Sheboygan
-
Stevens Point, Wisconsin, Forenede Stater, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Stevens Point, Wisconsin, Forenede Stater, 54481
- Aspirus Cancer Care - Stevens Point
-
Sturgeon Bay, Wisconsin, Forenede Stater, 54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Summit, Wisconsin, Forenede Stater, 53066
- Aurora Medical Center in Summit
-
Two Rivers, Wisconsin, Forenede Stater, 54241
- Vince Lombardi Cancer Clinic-Two Rivers
-
Waukesha, Wisconsin, Forenede Stater, 53188
- UW Cancer Center at ProHealth Care
-
Waukesha, Wisconsin, Forenede Stater, 53188
- ProHealth Waukesha Memorial Hospital
-
Wausau, Wisconsin, Forenede Stater, 54401
- Marshfield Clinic-Wausau Center
-
Wauwatosa, Wisconsin, Forenede Stater, 53226
- Aurora Cancer Care-Milwaukee West
-
West Allis, Wisconsin, Forenede Stater, 53227
- Aurora West Allis Medical Center
-
Weston, Wisconsin, Forenede Stater, 54476
- Marshfield Medical Center - Weston
-
Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
-
-
-
Osaka, Japan, 589 8511
- Kindai University
-
Saitama, Japan, 350-1298
- Saitama Medical University International Medical Center
-
Tokyo, Japan, 104 0045
- National Cancer Center Hospital
-
-
Ehime
-
Tōon, Ehime, Japan, 791-0295
- Ehime University Hospital
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 060-8648
- Hokkaido University Hospital
-
-
Kagoshima-ken
-
Kagoshima, Kagoshima-ken, Japan, 890-8760
- Kagoshima City Hospital
-
-
Tokyo
-
Koto-ku, Tokyo, Japan, 135-8550
- The Cancer Institute Hospital Of JFCR
-
-
-
-
-
San Juan, Puerto Rico, 00927
- Centro Comprensivo de Cancer de UPR
-
-
-
-
-
Incheon, Sydkorea, 405-760
- Gachon University Gil Hospital
-
Seoul, Sydkorea, 05505
- Asan Medical Center
-
Seoul, Sydkorea, 06273
- Gangnam Severance Hospital
-
Seoul, Sydkorea, 134-727
- Kyung Hee University Hospital at Gangdong
-
Seoul, Sydkorea, 139-706
- Korea Cancer Center Hospital
-
-
Daegu
-
Dalseo-gu, Daegu, Sydkorea, 42601
- Keimyung University-Dongsan Medical Center
-
-
Kyeonggi-do
-
Seongnam, Kyeonggi-do, Sydkorea, 463-707
- Seoul National University Bundang Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
-
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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
Andre navne:
Undergo CT
Andre navne:
Undergo MRI
Andre navne:
Ancillary studies Given IV
Andre navne:
Given IV
Andre navne:
Given IV
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
Undergo MRI
Andre navne:
Ancillary studies Given PO
Andre navne:
Given PO
Andre navne:
Given PO
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
Undergo MRI
Andre navne:
Ancillary studies Given PO
Andre navne:
Given PO
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
Undergo MRI
Andre navne:
Ancillary studies Given PO
Andre navne:
|
|
Aktiv komparator: 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
Andre navne:
Undergo CT
Andre navne:
Undergo MRI
Andre navne:
Ancillary studies Given IV
Andre navne:
Given IV
Andre navne:
Given IV
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
Undergo MRI
Andre navne:
Ancillary studies Given PO
Andre navne:
Given PO
Andre navne:
Given PO
Andre navne:
|
|
Eksperimentel: 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
Andre navne:
Undergo MRI
Andre navne:
Ancillary studies Given PO
Andre navne:
Given PO
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free Survival (PFS) (Phase II Only)
Tidsramme: The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. 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)
Tidsramme: The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Response Rate (Complete Response and Partial Response) (Phase II Only)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient-reported Scores of Disease-related Symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jung-min Lee, NRG Oncology
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Sygdomme i det endokrine system
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Kønssygdomme, kvindelige
- Neoplasmer i endokrine kirtler
- Ovariesygdomme
- Adnexale sygdomme
- Genitale neoplasmer, kvindelige
- Gonadale lidelser
- Æggeledersygdomme
- Ovariale neoplasmer
- Æggelederneoplasmer
- Organiske kemikalier
- Heterocykliske forbindelser
- Undersøgelsesteknikker
- Kulbrinter
- Cycloparaffiner
- Kulbrinter, alicyklisk
- Kulbrinter, cyklisk
- Terpenes
- Kulhydrater
- Camptothecin
- Alkaloider
- Polycykliske aromatiske kulbrinter
- Kulbrinter, aromatisk
- Polycykliske forbindelser
- Glycosider
- Taxoider
- Cyclodecanes
- Diterpenes
- Sundhedsøkonomi og organisationer
- Kemiteknikker, analytisk
- Spektrumanalyse
- Anthracycliner
- Naphthacenes
- Aminoglycosider
- Daunorubicin
- Økonomi
- Doxorubicin
- Paclitaxel
- Topotecan
- Magnetisk resonansspektroskopi
- Liposomal doxorubicin
- Olaparib
- Cediranib
- Skatter
Andre undersøgelses-id-numre
- NCI-2015-00651
- U10CA180868 (U.S. NIH-bevilling/kontrakt)
- NCI-2015-00651 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- NRG-GY005 (Anden identifikator: CTEP)
- s16-01681
- NRG-GY005
- NRG-GY005 (Anden identifikator: NRG Oncology)
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