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Testare la combinazione di cediranib e olaparib rispetto a ciascun farmaco da solo o altra chemioterapia nel carcinoma ovarico ricorrente resistente al platino

30 settembre 2026 aggiornato da: National Cancer Institute (NCI)

Uno studio randomizzato di fase II/III sulla combinazione di cediranib e olaparib rispetto a cediranib o olaparib da soli o chemioterapia standard in donne con carcinoma ovarico ricorrente resistente al platino o refrattario, tuba di Falloppio o carcinoma peritoneale primario (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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

582

Fase

  • Fase 2
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Regional Health Centre
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Sault Ste. Marie, Ontario, Canada, P6B 0A8
        • Algoma District Cancer Program Sault Area Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network-Princess Margaret Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Odette Cancer Centre- Sunnybrook Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM - Centre Hospitalier de l'Universite de Montreal
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSSEMTL-Hopital Maisonneuve-Rosemont
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
  • Corea del Sud
      • Incheon, Corea del Sud, 405-760
        • Gachon University Gil Hospital
      • Seoul, Corea del Sud, 05505
        • Asan Medical Center
      • Seoul, Corea del Sud, 06273
        • Gangnam Severance Hospital
      • Seoul, Corea del Sud, 134-727
        • Kyung Hee University Hospital at Gangdong
      • Seoul, Corea del Sud, 139-706
        • Korea Cancer Center Hospital
    • Daegu
      • Dalseo-gu, Daegu, Corea del Sud, 42601
        • Keimyung University-Dongsan Medical Center
    • Kyeonggi-do
      • Seongnam, Kyeonggi-do, Corea del Sud, 463-707
        • Seoul National University Bundang Hospital
  • Giappone
      • Osaka, Giappone, 589 8511
        • Kindai University
      • Saitama, Giappone, 350-1298
        • Saitama Medical University International Medical Center
      • Tokyo, Giappone, 104 0045
        • National Cancer Center Hospital
    • Ehime
      • Tōon, Ehime, Giappone, 791-0295
        • Ehime University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Giappone, 060-8648
        • Hokkaido University Hospital
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Giappone, 890-8760
        • Kagoshima City Hospital
    • Tokyo
      • Koto-ku, Tokyo, Giappone, 135-8550
        • The Cancer Institute Hospital Of JFCR
  • Porto Rico
      • San Juan, Porto Rico, 00927
        • Centro Comprensivo de Cancer de UPR
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35233
        • University of Alabama at Birmingham Cancer Center
    • Alaska
      • Anchorage, Alaska, Stati Uniti, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Stati Uniti, 99508
        • Providence Alaska Medical Center
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Auburn, California, Stati Uniti, 95602
        • Sutter Auburn Faith Hospital
      • Berkeley, California, Stati Uniti, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Carmichael, California, Stati Uniti, 95608
        • Mercy San Juan Medical Center
      • Elk Grove, California, Stati Uniti, 95758
        • Mercy Cancer Center - Elk Grove
      • Greenbrae, California, Stati Uniti, 94904
        • Marin Cancer Care Inc
      • La Jolla, California, Stati Uniti, 92093
        • UC San Diego Moores Cancer Center
      • Mountain View, California, Stati Uniti, 94040
        • Palo Alto Medical Foundation-Camino Division
      • Mountain View, California, Stati Uniti, 94040
        • Palo Alto Medical Foundation-Gynecologic Oncology
      • Oakland, California, Stati Uniti, 94611
        • Kaiser Permanente-Oakland
      • Palo Alto, California, Stati Uniti, 94301
        • Palo Alto Medical Foundation Health Care
      • Rocklin, California, Stati Uniti, 95765
        • Mercy Cancer Center - Rocklin
      • Roseville, California, Stati Uniti, 95661
        • Sutter Roseville Medical Center
      • Sacramento, California, Stati Uniti, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, Stati Uniti, 95817
        • University of California Davis Comprehensive Cancer Center
      • Sacramento, California, Stati Uniti, 95814
        • Kaiser Permanente Downtown Commons
      • Sacramento, California, Stati Uniti, 95825
        • Kaiser Permanente Sacramento Medical Center
      • Sacramento, California, Stati Uniti, 95816
        • Mercy Cancer Center - Sacramento
      • San Francisco, California, Stati Uniti, 94115
        • Kaiser Permanente-San Francisco
      • San Francisco, California, Stati Uniti, 94158
        • UCSF Medical Center-Mission Bay
      • San Francisco, California, Stati Uniti, 94115
        • California Pacific Medical Center-Pacific Campus
      • San Luis Obispo, California, Stati Uniti, 93401
        • Pacific Central Coast Health Center-San Luis Obispo
      • Santa Clara, California, Stati Uniti, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Cruz, California, Stati Uniti, 95065
        • Palo Alto Medical Foundation-Santa Cruz
      • Santa Rosa, California, Stati Uniti, 95403
        • Sutter Pacific Medical Foundation
      • Sunnyvale, California, Stati Uniti, 94086
        • Palo Alto Medical Foundation-Sunnyvale
      • Vallejo, California, Stati Uniti, 94589
        • Kaiser Permanente-Vallejo
      • Walnut Creek, California, Stati Uniti, 94596
        • Kaiser Permanente-Walnut Creek
      • Woodland, California, Stati Uniti, 95695
        • Woodland Memorial Hospital
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • UCHealth University of Colorado Hospital
      • Colorado Springs, Colorado, Stati Uniti, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, Stati Uniti, 80909
        • UCHealth Memorial Hospital Central
      • Denver, Colorado, Stati Uniti, 80205
        • Kaiser Permanente-Franklin
      • Denver, Colorado, Stati Uniti, 80220
        • Rocky Mountain Cancer Centers-Rose
      • Fort Collins, Colorado, Stati Uniti, 80524
        • Poudre Valley Hospital
      • Highlands Ranch, Colorado, Stati Uniti, 80129
        • UCHealth Highlands Ranch Hospital
      • Lafayette, Colorado, Stati Uniti, 80026
        • Kaiser Permanente-Rock Creek
      • Lone Tree, Colorado, Stati Uniti, 80124
        • Kaiser Permanente-Lone Tree
    • Connecticut
      • Danbury, Connecticut, Stati Uniti, 06810
        • Danbury Hospital
      • Fairfield, Connecticut, Stati Uniti, 06824
        • Smilow Cancer Hospital Care Center-Fairfield
      • Hartford, Connecticut, Stati Uniti, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • Hartford, Connecticut, Stati Uniti, 06102
        • Hartford Hospital
      • Middletown, Connecticut, Stati Uniti, 06457
        • Middlesex Hospital
      • New Britain, Connecticut, Stati Uniti, 06050
        • The Hospital of Central Connecticut
      • New Haven, Connecticut, Stati Uniti, 06520
        • Yale University
      • Norwalk, Connecticut, Stati Uniti, 06856
        • Norwalk Hospital
      • Trumbull, Connecticut, Stati Uniti, 06611
        • Smilow Cancer Hospital Care Center-Trumbull
    • Delaware
      • Newark, Delaware, Stati Uniti, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, Stati Uniti, 19713
        • Medical Oncology Hematology Consultants PA
      • Newark, Delaware, Stati Uniti, 19718
        • Christiana Care Health System-Christiana Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, Stati Uniti, 20016
        • Sibley Memorial Hospital
    • Florida
      • Gainesville, Florida, Stati Uniti, 32610
        • UF Health Cancer Institute - Gainesville
      • Miami Beach, Florida, Stati Uniti, 33140
        • Mount Sinai Medical Center
      • Orlando, Florida, Stati Uniti, 32806
        • Orlando Health Cancer Institute
      • Sarasota, Florida, Stati Uniti, 34239
        • Sarasota Memorial Hospital
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, Stati Uniti, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, Stati Uniti, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, Stati Uniti, 30342
        • Northside Hospital
      • Augusta, Georgia, Stati Uniti, 30912
        • Augusta University Medical Center
      • Austell, Georgia, Stati Uniti, 30106
        • WellStar Cobb Hospital
      • Marietta, Georgia, Stati Uniti, 30060
        • Wellstar Kennestone Hospital
      • Marietta, Georgia, Stati Uniti, 30060
        • WellStar Health System Inc
      • Roswell, Georgia, Stati Uniti, 30076
        • WellStar North Fulton Hospital
      • Savannah, Georgia, Stati Uniti, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
      • Savannah, Georgia, Stati Uniti, 31404
        • Memorial Health University Medical Center
      • Smyrna, Georgia, Stati Uniti, 30080
        • WellStar Vinings Health Park
    • Hawaii
      • Honolulu, Hawaii, Stati Uniti, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, Stati Uniti, 96826
        • Kapiolani Medical Center for Women and Children
    • Idaho
      • Boise, Idaho, Stati Uniti, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise, Idaho, Stati Uniti, 83712
        • Saint Luke's Cancer Institute - Boise
      • Fruitland, Idaho, Stati Uniti, 83619
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, Stati Uniti, 83642
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, Stati Uniti, 83687
        • Saint Luke's Cancer Institute - Nampa
    • Illinois
      • Aurora, Illinois, Stati Uniti, 60504
        • Rush-Copley Medical Center
      • Bloomington, Illinois, Stati Uniti, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, Stati Uniti, 61520
        • Illinois CancerCare-Canton
      • Carthage, Illinois, Stati Uniti, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, Stati Uniti, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, Stati Uniti, 60611
        • Northwestern University
      • Chicago, Illinois, Stati Uniti, 60612
        • John H Stroger Jr Hospital of Cook County
      • Chicago, Illinois, Stati Uniti, 60657
        • UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
      • Chicago, Illinois, Stati Uniti, 60612
        • Rush MD Anderson Cancer Center
      • Decatur, Illinois, Stati Uniti, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, Stati Uniti, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Effingham, Illinois, Stati Uniti, 62401
        • Crossroads Cancer Center
      • Eureka, Illinois, Stati Uniti, 61530
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, Stati Uniti, 60201
        • NorthShore University HealthSystem-Evanston Hospital
      • Galesburg, Illinois, Stati Uniti, 61401
        • Illinois CancerCare-Galesburg
      • Geneva, Illinois, Stati Uniti, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Glenview, Illinois, Stati Uniti, 60026
        • NorthShore University HealthSystem-Glenbrook Hospital
      • Highland Park, Illinois, Stati Uniti, 60035
        • NorthShore University HealthSystem-Highland Park Hospital
      • Hinsdale, Illinois, Stati Uniti, 60521
        • Sudarshan K Sharma MD Limited-Gynecologic Oncology
      • Kewanee, Illinois, Stati Uniti, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, Stati Uniti, 61455
        • Illinois CancerCare-Macomb
      • O'Fallon, Illinois, Stati Uniti, 62269
        • Cancer Care Center of O'Fallon
      • Ottawa, Illinois, Stati Uniti, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, Stati Uniti, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, Stati Uniti, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, Stati Uniti, 61354
        • Illinois CancerCare-Peru
      • Princeton, Illinois, Stati Uniti, 61356
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, Stati Uniti, 62702
        • Springfield Clinic
      • Springfield, Illinois, Stati Uniti, 62781
        • Springfield Memorial Hospital
      • Warrenville, Illinois, Stati Uniti, 60555
        • Northwestern Medicine Cancer Center Warrenville
      • Zion, Illinois, Stati Uniti, 60099
        • Midwestern Regional Medical Center
    • Indiana
      • Fort Wayne, Indiana, Stati Uniti, 46845
        • Parkview Regional Medical Center
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, Stati Uniti, 46260
        • Ascension Saint Vincent Indianapolis Hospital
      • Richmond, Indiana, Stati Uniti, 47374
        • Reid Health
      • South Bend, Indiana, Stati Uniti, 46601
        • Memorial Hospital of South Bend
    • Iowa
      • Clive, Iowa, Stati Uniti, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, Stati Uniti, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Des Moines, Iowa, Stati Uniti, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Stati Uniti, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Stati Uniti, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Des Moines, Iowa, Stati Uniti, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • Iowa City, Iowa, Stati Uniti, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • Sioux City, Iowa, Stati Uniti, 51101
        • Siouxland Regional Cancer Center
      • West Des Moines, Iowa, Stati Uniti, 50266
        • Mercy Medical Center-West Lakes
    • Kansas
      • Wichita, Kansas, Stati Uniti, 67214
        • Ascension Via Christi Hospitals Wichita
      • Wichita, Kansas, Stati Uniti, 67208
        • Associates In Womens Health
    • Kentucky
      • Edgewood, Kentucky, Stati Uniti, 41017
        • Saint Elizabeth Healthcare Edgewood
      • Lexington, Kentucky, Stati Uniti, 40536
        • University of Kentucky/Markey Cancer Center
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti, 70809
        • Mary Bird Perkins Cancer Center
      • Baton Rouge, Louisiana, Stati Uniti, 70809
        • Hematology/Oncology Clinic PLLC
      • Baton Rouge, Louisiana, Stati Uniti, 70817
        • Woman's Hospital
      • Covington, Louisiana, Stati Uniti, 70433
        • Women's Cancer Care-Covington
      • New Orleans, Louisiana, Stati Uniti, 70121
        • Ochsner Medical Center Jefferson
    • Maine
      • Bangor, Maine, Stati Uniti, 04401
        • Eastern Maine Medical Center
      • Brewer, Maine, Stati Uniti, 04412
        • Lafayette Family Cancer Center-EMMC
      • Scarborough, Maine, Stati Uniti, 04074
        • MaineHealth Maine Medical Center- Scarborough
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21237
        • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
      • Baltimore, Maryland, Stati Uniti, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Baltimore, Maryland, Stati Uniti, 21204
        • Greater Baltimore Medical Center
      • Bel Air, Maryland, Stati Uniti, 21014
        • UM Upper Chesapeake Medical Center
      • Bethesda, Maryland, Stati Uniti, 20892
        • National Institutes of Health Clinical Center
      • Ocean Pines, Maryland, Stati Uniti, 21811
        • TidalHealth Richard A Henson Cancer Institute
      • Salisbury, Maryland, Stati Uniti, 21801
        • TidalHealth Peninsula Regional
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Stati Uniti, 02115
        • Brigham and Women's Hospital
      • Worcester, Massachusetts, Stati Uniti, 01605
        • UMass Memorial Medical Center - Memorial Division
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • University of Michigan Rogel Cancer Center
      • Ann Arbor, Michigan, Stati Uniti, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Brownstown, Michigan, Stati Uniti, 48183
        • Henry Ford Cancer Institute-Downriver
      • Clinton Township, Michigan, Stati Uniti, 48038
        • Henry Ford Macomb Hospital-Clinton Township
      • Detroit, Michigan, Stati Uniti, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Stati Uniti, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Escanaba, Michigan, Stati Uniti, 49829
        • OSF Saint Francis Hospital and Medical Group
      • Farmington Hills, Michigan, Stati Uniti, 48334
        • Weisberg Cancer Treatment Center
      • Grand Rapids, Michigan, Stati Uniti, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Kalamazoo, Michigan, Stati Uniti, 49007
        • West Michigan Cancer Center
      • Lansing, Michigan, Stati Uniti, 48912
        • University of Michigan Health - Sparrow Lansing
      • Pontiac, Michigan, Stati Uniti, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
      • Traverse City, Michigan, Stati Uniti, 49684
        • Munson Medical Center
      • West Bloomfield, Michigan, Stati Uniti, 48322
        • Henry Ford West Bloomfield Hospital
    • Minnesota
      • Bemidji, Minnesota, Stati Uniti, 56601
        • Sanford Joe Lueken Cancer Center
      • Burnsville, Minnesota, Stati Uniti, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Stati Uniti, 55433
        • Mercy Hospital
      • Edina, Minnesota, Stati Uniti, 55435
        • Fairview Southdale Hospital
      • Mankato, Minnesota, Stati Uniti, 56001
        • Mayo Clinic Health Systems-Mankato
      • Maple Grove, Minnesota, Stati Uniti, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, Stati Uniti, 55109
        • Saint John's Hospital - Healtheast
      • Minneapolis, Minnesota, Stati Uniti, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, Stati Uniti, 55455
        • University of Minnesota/Masonic Cancer Center
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic in Rochester
      • Saint Louis Park, Minnesota, Stati Uniti, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, Stati Uniti, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Stati Uniti, 55102
        • United Hospital
      • Shakopee, Minnesota, Stati Uniti, 55379
        • Saint Francis Regional Medical Center
      • Woodbury, Minnesota, Stati Uniti, 55125
        • Minnesota Oncology Hematology PA-Woodbury
    • Mississippi
      • Jackson, Mississippi, Stati Uniti, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Cape Girardeau, Missouri, Stati Uniti, 63703
        • Saint Francis Medical Center
      • Columbia, Missouri, Stati Uniti, 65212
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • Joplin, Missouri, Stati Uniti, 64804
        • Mercy Hospital Joplin
      • Springfield, Missouri, Stati Uniti, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Stati Uniti, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Stati Uniti, 63110
        • Barnes-Jewish Hospital
      • St Louis, Missouri, Stati Uniti, 63110
        • Washington University School of Medicine
    • Montana
      • Billings, Montana, Stati Uniti, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, Stati Uniti, 59715
        • Bozeman Health Deaconess Hospital
      • Great Falls, Montana, Stati Uniti, 59405
        • Benefis Sletten Cancer Institute
    • Nebraska
      • Grand Island, Nebraska, Stati Uniti, 68803
        • Nebraska Cancer Specialists/Oncology Hematology West PC
      • Kearney, Nebraska, Stati Uniti, 68847
        • CHI Health Good Samaritan
      • Omaha, Nebraska, Stati Uniti, 68114
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, Stati Uniti, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, Stati Uniti, 68130
        • Alegent Health Lakeside Hospital
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89106
        • Women's Cancer Center of Nevada
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
      • Nashua, New Hampshire, Stati Uniti, 03063
        • Dartmouth Cancer Center - Nashua
    • New Jersey
      • Camden, New Jersey, Stati Uniti, 08103
        • Cooper Hospital University Medical Center
      • Hackensack, New Jersey, Stati Uniti, 07601
        • Hackensack University Medical Center
      • Hamilton, New Jersey, Stati Uniti, 08690
        • The Cancer Institute of New Jersey Hamilton
      • Morristown, New Jersey, Stati Uniti, 07960
        • Morristown Medical Center
      • Neptune City, New Jersey, Stati Uniti, 07753
        • Jersey Shore Medical Center
      • New Brunswick, New Jersey, Stati Uniti, 08903
        • Rutgers Cancer Institute of New Jersey
      • Somerville, New Jersey, Stati Uniti, 08876
        • Robert Wood Johnson University Hospital Somerset
      • Summit, New Jersey, Stati Uniti, 07902
        • Overlook Hospital
      • Voorhees Township, New Jersey, Stati Uniti, 08043
        • MD Anderson Cancer Center at Cooper-Voorhees
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87106
        • Southwest Gynecologic Oncology Associates Inc
      • Albuquerque, New Mexico, Stati Uniti, 87106
        • University of New Mexico Cancer Center
      • Las Cruces, New Mexico, Stati Uniti, 88011
        • Memorial Medical Center-Las Cruces
    • New York
      • Albany, New York, Stati Uniti, 12208
        • Women's Cancer Care Associates LLC
      • Brooklyn, New York, Stati Uniti, 11203
        • State University of New York Downstate Medical Center
      • Buffalo, New York, Stati Uniti, 14263
        • Roswell Park Cancer Institute
      • New York, New York, Stati Uniti, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Rochester, New York, Stati Uniti, 14642
        • University of Rochester
      • Stony Brook, New York, Stati Uniti, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, Stati Uniti, 13210
        • State University of New York Upstate Medical University
      • The Bronx, New York, Stati Uniti, 10461
        • Montefiore Medical Center-Einstein Campus
      • White Plains, New York, Stati Uniti, 10601
        • Dickstein Cancer Treatment Center
    • North Carolina
      • Asheville, North Carolina, Stati Uniti, 28803
        • AdventHealth Infusion Center Asheville
      • Chapel Hill, North Carolina, Stati Uniti, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Clyde, North Carolina, Stati Uniti, 28721
        • AdventHealth Infusion Center Haywood
      • Durham, North Carolina, Stati Uniti, 27710
        • Duke University Medical Center
      • Goldsboro, North Carolina, Stati Uniti, 27534
        • Southeastern Medical Oncology Center-Goldsboro
      • Hendersonville, North Carolina, Stati Uniti, 28791
        • Margaret R Pardee Memorial Hospital
      • Hendersonville, North Carolina, Stati Uniti, 28792
        • AdventHealth Hendersonville
      • Jacksonville, North Carolina, Stati Uniti, 28546
        • Southeastern Medical Oncology Center-Jacksonville
      • Pinehurst, North Carolina, Stati Uniti, 28374
        • FirstHealth of the Carolinas-Moore Regional Hospital
      • Raleigh, North Carolina, Stati Uniti, 27609
        • Duke Cancer Center Raleigh
      • Wilmington, North Carolina, Stati Uniti, 28401
        • Novant Health New Hanover Regional Medical Center
      • Winston-Salem, North Carolina, Stati Uniti, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Bismarck, North Dakota, Stati Uniti, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, Stati Uniti, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, Stati Uniti, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Akron, Ohio, Stati Uniti, 44307
        • Cleveland Clinic Akron General
      • Canton, Ohio, Stati Uniti, 44710
        • Aultman Health Foundation
      • Centerville, Ohio, Stati Uniti, 45459
        • Miami Valley Hospital South
      • Cincinnati, Ohio, Stati Uniti, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cincinnati, Ohio, Stati Uniti, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, Stati Uniti, 45247
        • TriHealth Cancer Institute-Westside
      • Cleveland, Ohio, Stati Uniti, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, Stati Uniti, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Stati Uniti, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, Stati Uniti, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Stati Uniti, 43210
        • Ohio State University Comprehensive Cancer Center
      • Columbus, Ohio, Stati Uniti, 43219
        • The Mark H Zangmeister Center
      • Dayton, Ohio, Stati Uniti, 45405
        • Grandview Hospital
      • Findlay, Ohio, Stati Uniti, 45840
        • Orion Cancer Care
      • Mayfield Heights, Ohio, Stati Uniti, 44124
        • Hillcrest Hospital Cancer Center
      • Sylvania, Ohio, Stati Uniti, 43560
        • ProMedica Flower Hospital
      • Toledo, Ohio, Stati Uniti, 43606
        • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
      • West Chester, Ohio, Stati Uniti, 45069
        • University of Cincinnati Cancer Center-West Chester
      • Wright-Patterson Air Force Base, Ohio, Stati Uniti, 45433
        • Wright-Patterson Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, Stati Uniti, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
      • Tulsa, Oklahoma, Stati Uniti, 74133
        • Cancer Treatment Centers of America
    • Oregon
      • Bend, Oregon, Stati Uniti, 97701
        • Saint Charles Health System
      • Gresham, Oregon, Stati Uniti, 97030
        • Legacy Mount Hood Medical Center
      • Portland, Oregon, Stati Uniti, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Tualatin, Oregon, Stati Uniti, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Abington, Pennsylvania, Stati Uniti, 19001
        • Jefferson Abington Hospital
      • Bethlehem, Pennsylvania, Stati Uniti, 18015
        • Saint Luke's University Hospital-Bethlehem Campus
      • Bryn Mawr, Pennsylvania, Stati Uniti, 19010
        • Bryn Mawr Hospital
      • Danville, Pennsylvania, Stati Uniti, 17822
        • Geisinger Medical Center
      • Ephrata, Pennsylvania, Stati Uniti, 17522
        • Ephrata Cancer Center
      • Ephrata, Pennsylvania, Stati Uniti, 17522
        • Ephrata Community Hospital
      • Gettysburg, Pennsylvania, Stati Uniti, 17325
        • Adams Cancer Center
      • Hanover, Pennsylvania, Stati Uniti, 17331
        • WellSpan Medical Oncology and Hematology
      • Harrisburg, Pennsylvania, Stati Uniti, 17109
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
      • Lebanon, Pennsylvania, Stati Uniti, 17042
        • Sechler Family Cancer Center
      • Lewisburg, Pennsylvania, Stati Uniti, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Paoli, Pennsylvania, Stati Uniti, 19301
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • University of Pennsylvania/Abramson Cancer Center
      • Pittsburgh, Pennsylvania, Stati Uniti, 15224
        • West Penn Hospital
      • Sayre, Pennsylvania, Stati Uniti, 18840
        • Guthrie Medical Group PC-Robert Packer Hospital
      • West Reading, Pennsylvania, Stati Uniti, 19611
        • Reading Hospital
      • Wexford, Pennsylvania, Stati Uniti, 15090
        • Wexford Health and Wellness Pavilion
      • Williamsport, Pennsylvania, Stati Uniti, 17701
        • UPMC Susquehanna
      • Willow Grove, Pennsylvania, Stati Uniti, 19090
        • Asplundh Cancer Pavilion
      • Wynnewood, Pennsylvania, Stati Uniti, 19096
        • Lankenau Medical Center
      • York, Pennsylvania, Stati Uniti, 17403
        • WellSpan Health-York Hospital
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02905
        • Women and Infants Hospital
    • South Carolina
      • Anderson, South Carolina, Stati Uniti, 29621
        • AnMed Health Cancer Center
      • Gaffney, South Carolina, Stati Uniti, 29341
        • Gibbs Cancer Center-Gaffney
      • Greenville, South Carolina, Stati Uniti, 29607
        • Saint Francis Cancer Center
      • Greenville, South Carolina, Stati Uniti, 29601
        • Saint Francis Hospital
      • Greer, South Carolina, Stati Uniti, 29651
        • Gibbs Cancer Center-Pelham
      • Hilton Head Island, South Carolina, Stati Uniti, 29926-3827
        • South Carolina Cancer Specialists PC
      • Spartanburg, South Carolina, Stati Uniti, 29303
        • Spartanburg Medical Center
      • Union, South Carolina, Stati Uniti, 29379
        • SMC Center for Hematology Oncology Union
    • South Dakota
      • Rapid City, South Dakota, Stati Uniti, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Stati Uniti, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Stati Uniti, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, Stati Uniti, 57104
        • Sanford Cancer Center Oncology Clinic
    • Tennessee
      • Kingsport, Tennessee, Stati Uniti, 37660
        • Ballad Health Cancer Care - Kingsport
      • Kingsport, Tennessee, Stati Uniti, 37660
        • Wellmont Holston Valley Hospital and Medical Center
      • Knoxville, Tennessee, Stati Uniti, 37916
        • Covenant Health Cancer Centers
      • Knoxville, Tennessee, Stati Uniti, 37932
        • Covenant Health Cancer Centers - West
      • Nashville, Tennessee, Stati Uniti, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Dallas, Texas, Stati Uniti, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, Stati Uniti, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Houston, Texas, Stati Uniti, 77030
        • Houston Methodist Hospital
      • Houston, Texas, Stati Uniti, 77070
        • Methodist Willowbrook Hospital
      • Sugar Land, Texas, Stati Uniti, 77479
        • Houston Methodist Sugar Land Hospital
    • Utah
      • Murray, Utah, Stati Uniti, 84107
        • Intermountain Medical Center
      • Salt Lake City, Utah, Stati Uniti, 84112
        • Huntsman Cancer Institute/University of Utah
      • Salt Lake City, Utah, Stati Uniti, 84106
        • Utah Cancer Specialists-Salt Lake City
      • South Jordan, Utah, Stati Uniti, 84009
        • South Jordan Health Center
      • St. George, Utah, Stati Uniti, 84770
        • Saint George Regional Medical Center
    • Vermont
      • Berlin Corners, Vermont, Stati Uniti, 05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington, Vermont, Stati Uniti, 05401
        • University of Vermont Medical Center
      • Burlington, Vermont, Stati Uniti, 05405
        • University of Vermont and State Agricultural College
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22908
        • University of Virginia Cancer Center
      • Richmond, Virginia, Stati Uniti, 23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond, Virginia, Stati Uniti, 23298
        • VCU Massey Comprehensive Cancer Center
    • Washington
      • Bellingham, Washington, Stati Uniti, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Edmonds, Washington, Stati Uniti, 98026
        • Swedish Cancer Institute-Edmonds
      • Kennewick, Washington, Stati Uniti, 99336
        • Kadlec Clinic Hematology and Oncology
      • Mount Vernon, Washington, Stati Uniti, 98274
        • Skagit Valley Hospital
      • Mount Vernon, Washington, Stati Uniti, 98274
        • Skagit Regional Health Cancer Care Center
      • Seattle, Washington, Stati Uniti, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, Stati Uniti, 98195
        • University of Washington Medical Center - Montlake
      • Seattle, Washington, Stati Uniti, 98104
        • Pacific Gynecology Specialists
      • Seattle, Washington, Stati Uniti, 98109
        • Fred Hutchinson Cancer Center
      • Seattle, Washington, Stati Uniti, 98133
        • University of Washington Medical Center - Northwest
      • Seattle, Washington, Stati Uniti, 98133
        • Women's Cancer Center of Seattle
      • Vancouver, Washington, Stati Uniti, 98686
        • Legacy Salmon Creek Hospital
      • Wenatchee, Washington, Stati Uniti, 98801
        • Wenatchee Valley Hospital and Clinics
    • West Virginia
      • Charleston, West Virginia, Stati Uniti, 25304
        • Vandalia Health/CAMC Institute for Academic Medicine
      • Huntington, West Virginia, Stati Uniti, 25701
        • Edwards Comprehensive Cancer Center
      • Morgantown, West Virginia, Stati Uniti, 26506
        • West Virginia University Healthcare
      • Morgantown, West Virginia, Stati Uniti, 26505
        • Monongalia Hospital
    • Wisconsin
      • Appleton, Wisconsin, Stati Uniti, 54915
        • Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
      • Burlington, Wisconsin, Stati Uniti, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Chippewa Falls, Wisconsin, Stati Uniti, 54729
        • Marshfield Clinic-Chippewa Center
      • Eau Claire, Wisconsin, Stati Uniti, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Fond du Lac, Wisconsin, Stati Uniti, 54937
        • Aurora Health Center-Fond du Lac
      • Germantown, Wisconsin, Stati Uniti, 53022
        • Aurora Health Care Germantown Health Center
      • Grafton, Wisconsin, Stati Uniti, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, Stati Uniti, 54311
        • Aurora BayCare Medical Center
      • Green Bay, Wisconsin, Stati Uniti, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, Stati Uniti, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Kenosha, Wisconsin, Stati Uniti, 53142
        • Aurora Cancer Care-Kenosha South
      • La Crosse, Wisconsin, Stati Uniti, 54601
        • Gundersen Lutheran Medical Center
      • Ladysmith, Wisconsin, Stati Uniti, 54848
        • Marshfield Medical Center - Ladysmith
      • Madison, Wisconsin, Stati Uniti, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Marinette, Wisconsin, Stati Uniti, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Marinette, Wisconsin, Stati Uniti, 54143
        • Saint Vincent Hospital Cancer Center at Marinette
      • Marshfield, Wisconsin, Stati Uniti, 54449
        • Marshfield Medical Center-Marshfield
      • Mequon, Wisconsin, Stati Uniti, 53097
        • Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 53209
        • Aurora Cancer Care-Milwaukee
      • Milwaukee, Wisconsin, Stati Uniti, 53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee, Wisconsin, Stati Uniti, 53233
        • Aurora Sinai Medical Center
      • Milwaukee, Wisconsin, Stati Uniti, 53211
        • Ascension Columbia Saint Mary's Hospital-Milwaukee Campus
      • Minocqua, Wisconsin, Stati Uniti, 54548
        • Marshfield Medical Center - Minocqua
      • Mukwonago, Wisconsin, Stati Uniti, 53149
        • ProHealth D N Greenwald Center
      • Oconomowoc, Wisconsin, Stati Uniti, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oconto Falls, Wisconsin, Stati Uniti, 54154
        • Saint Vincent Hospital Cancer Center at Oconto Falls
      • Oshkosh, Wisconsin, Stati Uniti, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Oshkosh, Wisconsin, Stati Uniti, 54904
        • Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh
      • Racine, Wisconsin, Stati Uniti, 53406
        • Aurora Cancer Care-Racine
      • Rice Lake, Wisconsin, Stati Uniti, 54868
        • Marshfield Medical Center-Rice Lake
      • Sheboygan, Wisconsin, Stati Uniti, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Stevens Point, Wisconsin, Stati Uniti, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Stevens Point, Wisconsin, Stati Uniti, 54481
        • Aspirus Cancer Care - Stevens Point
      • Sturgeon Bay, Wisconsin, Stati Uniti, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
      • Summit, Wisconsin, Stati Uniti, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, Stati Uniti, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Waukesha, Wisconsin, Stati Uniti, 53188
        • UW Cancer Center at ProHealth Care
      • Waukesha, Wisconsin, Stati Uniti, 53188
        • ProHealth Waukesha Memorial Hospital
      • Wausau, Wisconsin, Stati Uniti, 54401
        • Marshfield Clinic-Wausau Center
      • Wauwatosa, Wisconsin, Stati Uniti, 53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis, Wisconsin, Stati Uniti, 53227
        • Aurora West Allis Medical Center
      • Weston, Wisconsin, Stati Uniti, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, Stati Uniti, 54494
        • Marshfield Clinic - Wisconsin Rapids Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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)
Droga: Paclitaxel

Given IV

Altri nomi:
  • Tassolo
  • Anzatax
  • Asotax
  • Bristaxolo
  • Praxel
  • Taxol Konzentrat
Procedura: Computed Tomography

Undergo CT

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • Imaging medico, risonanza magnetica/risonanza magnetica nucleare
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Risonanza Magnetica Nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Altro: Questionnaire Administration

Ancillary studies

Droga: Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

Altri nomi:
  • ATI-0918
  • Celice
  • Doxil
  • Doxilen
  • Doxorubicina HCl liposoma
  • Duomeisu
  • Evacet
  • LipDox
  • Adriamicina liposomiale
  • Doxorubicina incapsulata in liposomi
  • Liposoma doxorubicina HCl pegilato
  • Doxorubicina S-liposomiale
  • Doxorubicina liposomiale invisibile
  • TLC D-99
  • Dox SL
  • Doxorubicina HCl liposomiale
  • Liposoma doxorubicina cloridrato
  • Lipox 50
  • Doxorubicina cloridrato liposomiale
  • Doxorubicina liposomiale pegilata
  • Doxorubicina Liposomiale
Droga: Topotecan

Given IV

Altri nomi:
  • Icamptamina
  • Topotecan lattone
Droga: Topotecan Hydrochloride

Given IV

Altri nomi:
  • Hycamtin
  • Icamptamina
  • SKF S-104864-A
  • Topotecan HCl
  • topotecan cloridrato (orale)
  • Potactasolo
  • Evotopina
  • Topotec
  • Nogitecan cloridrato
  • SKF S104864 A
  • SKF S104864A
Sperimentale: 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.
Procedura: Computed Tomography

Undergo CT

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • Imaging medico, risonanza magnetica/risonanza magnetica nucleare
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Risonanza Magnetica Nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Altro: Questionnaire Administration

Ancillary studies

Droga: Cediranib Maleate

Given PO

Altri nomi:
  • AZD2171
  • AZD2171 Maleato
  • Recentin
Droga: Olaparib

Given PO

Altri nomi:
  • Lynparz
  • AZD 2281
  • AZD-2281
  • AZD2281
  • KU-0059436
  • Inibitore PARP AZD2281
  • KU0059436
  • Olanib
  • Olaparix
Droga: Cediranib

Given PO

Altri nomi:
  • AZD2171
  • AZ-D2171
  • AZD 2171
Sperimentale: 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.
Procedura: Computed Tomography

Undergo CT

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • Imaging medico, risonanza magnetica/risonanza magnetica nucleare
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Risonanza Magnetica Nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Altro: Questionnaire Administration

Ancillary studies

Droga: Cediranib Maleate

Given PO

Altri nomi:
  • AZD2171
  • AZD2171 Maleato
  • Recentin
Droga: Cediranib

Given PO

Altri nomi:
  • AZD2171
  • AZ-D2171
  • AZD 2171
Sperimentale: 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).
Procedura: Computed Tomography

Undergo CT

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • Imaging medico, risonanza magnetica/risonanza magnetica nucleare
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Risonanza Magnetica Nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Altro: Questionnaire Administration

Ancillary studies

Droga: Olaparib

Given PO

Altri nomi:
  • Lynparz
  • AZD 2281
  • AZD-2281
  • AZD2281
  • KU-0059436
  • Inibitore PARP AZD2281
  • KU0059436
  • Olanib
  • Olaparix
Comparatore attivo: 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)
Droga: Paclitaxel

Given IV

Altri nomi:
  • Tassolo
  • Anzatax
  • Asotax
  • Bristaxolo
  • Praxel
  • Taxol Konzentrat
Procedura: Computed Tomography

Undergo CT

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • Imaging medico, risonanza magnetica/risonanza magnetica nucleare
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Risonanza Magnetica Nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Altro: Questionnaire Administration

Ancillary studies

Droga: Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

Altri nomi:
  • ATI-0918
  • Celice
  • Doxil
  • Doxilen
  • Doxorubicina HCl liposoma
  • Duomeisu
  • Evacet
  • LipDox
  • Adriamicina liposomiale
  • Doxorubicina incapsulata in liposomi
  • Liposoma doxorubicina HCl pegilato
  • Doxorubicina S-liposomiale
  • Doxorubicina liposomiale invisibile
  • TLC D-99
  • Dox SL
  • Doxorubicina HCl liposomiale
  • Liposoma doxorubicina cloridrato
  • Lipox 50
  • Doxorubicina cloridrato liposomiale
  • Doxorubicina liposomiale pegilata
  • Doxorubicina Liposomiale
Droga: Topotecan

Given IV

Altri nomi:
  • Icamptamina
  • Topotecan lattone
Droga: Topotecan Hydrochloride

Given IV

Altri nomi:
  • Hycamtin
  • Icamptamina
  • SKF S-104864-A
  • Topotecan HCl
  • topotecan cloridrato (orale)
  • Potactasolo
  • Evotopina
  • Topotec
  • Nogitecan cloridrato
  • SKF S104864 A
  • SKF S104864A
Sperimentale: 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.
Procedura: Computed Tomography

Undergo CT

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • Imaging medico, risonanza magnetica/risonanza magnetica nucleare
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Risonanza Magnetica Nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Altro: Questionnaire Administration

Ancillary studies

Droga: Cediranib Maleate

Given PO

Altri nomi:
  • AZD2171
  • AZD2171 Maleato
  • Recentin
Droga: Olaparib

Given PO

Altri nomi:
  • Lynparz
  • AZD 2281
  • AZD-2281
  • AZD2281
  • KU-0059436
  • Inibitore PARP AZD2281
  • KU0059436
  • Olanib
  • Olaparix
Droga: Cediranib

Given PO

Altri nomi:
  • AZD2171
  • AZ-D2171
  • AZD 2171
Sperimentale: 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.
Procedura: Computed Tomography

Undergo CT

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • Imaging medico, risonanza magnetica/risonanza magnetica nucleare
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Risonanza Magnetica Nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Altro: Questionnaire Administration

Ancillary studies

Droga: Cediranib Maleate

Given PO

Altri nomi:
  • AZD2171
  • AZD2171 Maleato
  • Recentin
Droga: Cediranib

Given PO

Altri nomi:
  • AZD2171
  • AZ-D2171
  • AZD 2171

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free Survival (PFS) (Phase II Only)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective Response Rate (Complete Response and Partial Response) (Phase II Only)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient-reported Scores of Disease-related Symptoms
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Collaboratori

NRG Oncology
Canadian Cancer Trials Group

Investigatori

  • Investigatore principale: Jung-min Lee, NRG Oncology

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 maggio 2016

Completamento primario (Effettivo)

12 giugno 2023

Completamento dello studio (Stimato)

4 marzo 2027

Date di iscrizione allo studio

Primo inviato

17 luglio 2015

Primo inviato che soddisfa i criteri di controllo qualità

17 luglio 2015

Primo Inserito (Stimato)

20 luglio 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCI-2015-00651
  • U10CA180868 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2015-00651 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • NRG-GY005 (Altro identificatore: CTEP)
  • s16-01681
  • NRG-GY005
  • NRG-GY005 (Altro identificatore: NRG Oncology)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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