진행성 카르시노이드 종양 환자를 치료하는 파조파닙 염산염
진행성 카르시노이드 종양 환자에서 파조파닙(NSC # 737754) 대 위약의 전향적 무작위 2상 시험
This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with carcinoid tumors that are growing, spreading, or getting worse. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
PRIMARY OBJECTIVE:
I. For patients with progressive carcinoid tumors, progression-free survival (PFS defined by central review according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) will be compared between patients randomized to treatment with pazopanib (pazopanib hydrochloride) versus placebo.
SECONDARY OBJECTIVES:
I. Overall survival (OS) will be compared between treatment arms. II. Objective response rate, duration of response, and time to treatment failure will be compared between treatment arms.
III. Progression free survival (PFS) as assessed by central radiology review and local radiology review will be compared overall and within treatment arms.
IV. Safety and tolerability of treatment with pazopanib/placebo will be evaluated within each treatment arm.
V. PFS and other indicators of efficacy will be estimated in patients who crossover to pazopanib from placebo.
VI. To determine the turn-around time for timely adjudicated central review. VII. To characterize the nature of discordance between local and central radiology review in assessment of progression.
VIII. To characterize the type and rate of progression in carcinoid (at study entry, on-study, and at progression).
IX. To develop new methods for modeling carcinoid growth and detecting treatment effects, and to perform simulations that advance new clinical trial designs to apply to future trials of carcinoid therapeutics.
X. To assess for differences in quality of life (QOL)-related domains between the two treatment groups (pazopanib versus placebo).
XI. To determine if the more brief measures of QOL-related domains provide comparable information to that which is provided by the longer assessments (European Organization for Research and Treatment of Cancer [EORTC], neuroendocrine tumors [NET]21).
XII. To provide validation data for the EORTC NET21 module in terms of responsiveness over time and differences across arms.
XIII. To determine whether components of the plasma angiome panel that have been shown to be predictive previously (interleukin-6 [IL-6] and vascular endothelial growth factor [VEGF]-D) are predictive of a therapeutic advantage for pazopanib treatment in baseline samples from the patients treated on A021202.
XIV. To determine whether other components of the plasma angiome panel tested (not IL-6 and VEGF-D) are predictive of a therapeutic advantage for pazopanib treatment in baseline samples from the patients treated on A021202.
XV. To evaluate the changes in the plasma angiome markers after treatment with or without pazopanib over time.
EXPLORATORY OBJECTIVES:
I. PFS at 6 months will be estimated within each treatment arm. II. Biochemical response (for chromogranin A, defined as a decrease of 50% or more in chromogranin A levels from baseline and for 5-hydroxyindoleacetic acid [5-HIAA], defined as a decrease of 50% or more in urinary 5-HIAA levels from baseline) will be compared between treatment arms among patients with elevated baseline levels of chromogranin A (CGA) and 5-HIAA.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), and chest x-ray throughout the trial. Patients may optionally undergo blood sample collection during screening and on study.
ARM II: Patients receive placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I. Patients undergo ECHO or MUGA during screening. Patients also undergo CT, MRI, and chest x-ray throughout the trial. Patients may optionally undergo blood sample collection during screening and on study.
After completion of study treatment, patients are followed up every 3-6 months for 5 years.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 장소
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Alaska
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Anchorage, Alaska, 미국, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, 미국, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, 미국, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, 미국, 99508
- Katmai Oncology Group
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Anchorage, Alaska, 미국, 99508
- Providence Alaska Medical Center
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Arizona
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Scottsdale, Arizona, 미국, 85259
- Mayo Clinic in Arizona
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California
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Anaheim, California, 미국, 92806
- Kaiser Permanente-Anaheim
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Baldwin Park, California, 미국, 91706
- Kaiser Permanente-Baldwin Park
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Fontana, California, 미국, 92335
- Kaiser Permanente-Fontana
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Harbor City, California, 미국, 90710
- Kaiser Permanente South Bay
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Irvine, California, 미국, 92618
- Kaiser Permanente-Irvine
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Los Angeles, California, 미국, 90033
- USC / Norris Comprehensive Cancer Center
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Los Angeles, California, 미국, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, 미국, 90027
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, 미국, 90034
- Kaiser Permanente West Los Angeles
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Los Angeles, California, 미국, 90033
- Los Angeles General Medical Center
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Palo Alto, California, 미국, 94304
- Stanford Cancer Institute Palo Alto
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Palo Alto, California, 미국, 94301
- Palo Alto Medical Foundation Health Care
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Panorama City, California, 미국, 91402
- Kaiser Permanente - Panorama City
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Riverside, California, 미국, 92505
- Kaiser Permanente-Riverside
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San Diego, California, 미국, 92120
- Kaiser Permanente-San Diego Zion
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San Diego, California, 미국, 92108
- Kaiser Permanente-Rio San Diego
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San Francisco, California, 미국, 94158
- UCSF Medical Center-Mission Bay
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San Francisco, California, 미국, 94115
- UCSF Medical Center-Mount Zion
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San Marcos, California, 미국, 92078
- Kaiser Permanente-San Marcos
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Santa Cruz, California, 미국, 95065
- Palo Alto Medical Foundation-Santa Cruz
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Sunnyvale, California, 미국, 94086
- Palo Alto Medical Foundation-Sunnyvale
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Woodland Hills, California, 미국, 91367
- Kaiser Permanente-Woodland Hills
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Colorado
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Aurora, Colorado, 미국, 80012
- The Medical Center of Aurora
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Boulder, Colorado, 미국, 80303
- Boulder Community Foothills Hospital
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Boulder, Colorado, 미국, 80304
- Rocky Mountain Cancer Centers-Boulder
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Colorado Springs, Colorado, 미국, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, 미국, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, 미국, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, 미국, 80220
- Rose Medical Center
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Denver, Colorado, 미국, 80218
- Rocky Mountain Cancer Centers-Midtown
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Denver, Colorado, 미국, 80220
- Rocky Mountain Cancer Centers-Rose
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Denver, Colorado, 미국, 80218
- Colorado Blood Cancer Institute
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Denver, Colorado, 미국, 80222
- Western States Cancer Research NCORP
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Denver, Colorado, 미국, 80218
- Saint Joseph Hospital - Cancer Centers of Colorado
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Denver, Colorado, 미국, 80210
- AdventHealth Porter
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Durango, Colorado, 미국, 81301
- Mercy Medical Center
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Englewood, Colorado, 미국, 80113
- Mountain Blue Cancer Care Center - Swedish
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Englewood, Colorado, 미국, 80113
- Swedish Medical Center
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Fort Collins, Colorado, 미국, 80524
- Poudre Valley Hospital
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Golden, Colorado, 미국, 80401
- Mountain Blue Cancer Care Center
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Greeley, Colorado, 미국, 80631
- Banner North Colorado Medical Center
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Greenwood Village, Colorado, 미국, 80111
- Rocky Mountain Cancer Centers-Greenwood Village
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Lakewood, Colorado, 미국, 80228
- Rocky Mountain Cancer Centers-Lakewood
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Lakewood, Colorado, 미국, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, 미국, 80122
- AdventHealth Littleton
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Lone Tree, Colorado, 미국, 80124
- Sky Ridge Medical Center
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Lone Tree, Colorado, 미국, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Longmont, Colorado, 미국, 80501
- Longmont United Hospital
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Longmont, Colorado, 미국, 80501
- Rocky Mountain Cancer Centers-Longmont
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Loveland, Colorado, 미국, 80539
- Banner North Colorado Medical Center - Loveland Campus
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Parker, Colorado, 미국, 80138
- Rocky Mountain Cancer Centers-Parker
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Parker, Colorado, 미국, 80138
- AdventHealth Parker
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Pueblo, Colorado, 미국, 81004
- Saint Mary Corwin Medical Center
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Pueblo, Colorado, 미국, 81008
- Rocky Mountain Cancer Centers - Pueblo
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Wheat Ridge, Colorado, 미국, 80401
- Intermountain Health Lutheran Hospital
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Connecticut
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Hartford, Connecticut, 미국, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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Delaware
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Lewes, Delaware, 미국, 19958
- Beebe Medical Center
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Newark, Delaware, 미국, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, 미국, 19713
- Delaware Clinical and Laboratory Physicians PA
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Newark, Delaware, 미국, 19713
- Medical Oncology Hematology Consultants PA
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Newark, Delaware, 미국, 19718
- Christiana Care Health System-Christiana Hospital
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Rehoboth Beach, Delaware, 미국, 19971
- Beebe Health Campus
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Seaford, Delaware, 미국, 19973
- TidalHealth Nanticoke / Allen Cancer Center
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Wilmington, Delaware, 미국, 19801
- Christiana Care Health System-Wilmington Hospital
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Florida
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Tampa, Florida, 미국, 33612
- Moffitt Cancer Center
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Georgia
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Columbus, Georgia, 미국, 31904
- John B Amos Cancer Center
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Savannah, Georgia, 미국, 31404
- Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, 미국, 96813
- Queen's Medical Center
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Honolulu, Hawaii, 미국, 96813
- Hawaii Cancer Care Inc - Waterfront Plaza
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Honolulu, Hawaii, 미국, 96813
- Straub Clinic and Hospital
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Honolulu, Hawaii, 미국, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, 미국, 96817
- Hawaii Cancer Care Inc-Liliha
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Honolulu, Hawaii, 미국, 96817
- Queen's Cancer Center - Kuakini
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Honolulu, Hawaii, 미국, 96826
- Kapiolani Medical Center for Women and Children
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Kailua, Hawaii, 미국, 96734
- Castle Medical Center
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Lihue, Hawaii, 미국, 96766
- Wilcox Memorial Hospital and Kauai Medical Clinic
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‘Aiea, Hawaii, 미국, 96701
- Pali Momi Medical Center
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‘Aiea, Hawaii, 미국, 96701
- Queen's Cancer Center - Pearlridge
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Idaho
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Boise, Idaho, 미국, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Post Falls, Idaho, 미국, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Illinois
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Bloomington, Illinois, 미국, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, 미국, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, 미국, 62321
- Illinois CancerCare-Carthage
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Chicago, Illinois, 미국, 60611
- Northwestern University
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Chicago, Illinois, 미국, 60637
- University of Chicago Comprehensive Cancer Center
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Decatur, Illinois, 미국, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, 미국, 62526
- Cancer Care Specialists of Illinois - Decatur
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Eureka, Illinois, 미국, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, 미국, 61401
- Illinois CancerCare-Galesburg
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Harvey, Illinois, 미국, 60426
- Ingalls Memorial Hospital
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Kewanee, Illinois, 미국, 61443
- Illinois CancerCare-Kewanee Clinic
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Macomb, Illinois, 미국, 61455
- Illinois CancerCare-Macomb
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Maywood, Illinois, 미국, 60153
- Loyola University Medical Center
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Mount Vernon, Illinois, 미국, 62864
- SSM Health Good Samaritan
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Ottawa, Illinois, 미국, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, 미국, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, 미국, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, 미국, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, 미국, 61356
- Illinois CancerCare-Princeton
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Indiana
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Elkhart, Indiana, 미국, 46515
- Elkhart General Hospital
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Elkhart, Indiana, 미국, 46514
- Michiana Hematology Oncology PC-Elkhart
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Elkhart, Indiana, 미국, 46514-2098
- Elkhart Clinic
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Indianapolis, Indiana, 미국, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Kokomo, Indiana, 미국, 46904
- Community Howard Regional Health
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La Porte, Indiana, 미국, 46350
- IU Health La Porte Hospital
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Mishawaka, Indiana, 미국, 46545
- Michiana Hematology Oncology PC-Mishawaka
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Mishawaka, Indiana, 미국, 46545
- Saint Joseph Regional Medical Center-Mishawaka
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Plymouth, Indiana, 미국, 46563
- Michiana Hematology Oncology PC-Plymouth
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Richmond, Indiana, 미국, 47374
- Reid Health
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South Bend, Indiana, 미국, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, 미국, 46628
- Northern Indiana Cancer Research Consortium
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South Bend, Indiana, 미국, 46617
- South Bend Clinic
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Westville, Indiana, 미국, 46391
- Michiana Hematology Oncology PC-Westville
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Iowa
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Ames, Iowa, 미국, 50010
- Mary Greeley Medical Center
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Ames, Iowa, 미국, 50010
- McFarland Clinic - Ames
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Bettendorf, Iowa, 미국, 52722
- University of Iowa Healthcare Cancer Services Quad Cities
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Boone, Iowa, 미국, 50036
- McFarland Clinic - Boone
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Cedar Rapids, Iowa, 미국, 52403
- Mercy Hospital
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Cedar Rapids, Iowa, 미국, 52403
- Oncology Associates at Mercy Medical Center
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Clive, Iowa, 미국, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, 미국, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Des Moines, Iowa, 미국, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, 미국, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, 미국, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, 미국, 50309
- Iowa-Wide Oncology Research Coalition NCORP
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Des Moines, Iowa, 미국, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, 미국, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Iowa City, Iowa, 미국, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Jefferson, Iowa, 미국, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, 미국, 50158
- McFarland Clinic - Marshalltown
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Sioux City, Iowa, 미국, 51101
- Siouxland Regional Cancer Center
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Sioux City, Iowa, 미국, 51102
- Mercy Medical Center-Sioux City
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Sioux City, Iowa, 미국, 51104
- Saint Luke's Regional Medical Center
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West Des Moines, Iowa, 미국, 50266-7700
- Methodist West Hospital
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West Des Moines, Iowa, 미국, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Emporia, Kansas, 미국, 66801
- Newman Regional Health
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Garden City, Kansas, 미국, 67846
- Saint Catherine Hospital
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Great Bend, Kansas, 미국, 67530
- Saint Rose Ambulatory and Surgery Center
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Hays, Kansas, 미국, 67601
- HaysMed
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Kansas City, Kansas, 미국, 66160
- University of Kansas Cancer Center
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Kansas City, Kansas, 미국, 66112
- University of Kansas Cancer Center-West
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Olathe, Kansas, 미국, 66061
- The University of Kansas Cancer Center - Olathe
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Overland Park, Kansas, 미국, 66210
- University of Kansas Cancer Center-Overland Park
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Overland Park, Kansas, 미국, 66209
- Menorah Medical Center
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Overland Park, Kansas, 미국, 66213
- Saint Luke's South Hospital
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Pittsburg, Kansas, 미국, 66762
- Mercy Hospital Pittsburg
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Prairie Village, Kansas, 미국, 66208
- Kansas City NCI Community Oncology Research Program
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Salina, Kansas, 미국, 67401
- Salina Regional Health Center
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Topeka, Kansas, 미국, 66606
- University of Kansas Health System Saint Francis Campus
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Wichita, Kansas, 미국, 67214
- Cancer Center of Kansas - Wichita
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Kentucky
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Crestview Hills, Kentucky, 미국, 41017
- Oncology Hematology Care Inc-Crestview
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Elizabethtown, Kentucky, 미국, 42701
- Baptist Health Hardin
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Lexington, Kentucky, 미국, 40503
- Baptist Health Lexington
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Louisiana
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Baton Rouge, Louisiana, 미국, 70809
- Ochsner Health Center-Summa
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New Orleans, Louisiana, 미국, 70121
- Ochsner Medical Center Jefferson
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Michigan
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Adrian, Michigan, 미국, 49221
- Bixby Medical Center
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Adrian, Michigan, 미국, 49221
- Hickman Cancer Center
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Ann Arbor, Michigan, 미국, 48106
- Michigan Cancer Research Consortium NCORP
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Ann Arbor, Michigan, 미국, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Battle Creek, Michigan, 미국, 49017
- Bronson Battle Creek
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Dearborn, Michigan, 미국, 48124
- Corewell Health Dearborn Hospital
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Detroit, Michigan, 미국, 48236
- Henry Ford Health Saint John Hospital
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Escanaba, Michigan, 미국, 49829
- OSF Saint Francis Hospital and Medical Group
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Flint, Michigan, 미국, 48503
- Hurley Medical Center
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Flint, Michigan, 미국, 48503
- Genesys Hurley Cancer Institute
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Grand Rapids, Michigan, 미국, 49503
- Cancer Research Consortium of West Michigan NCORP
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Grand Rapids, Michigan, 미국, 49503
- Trinity Health Grand Rapids Hospital
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Grand Rapids, Michigan, 미국, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Jackson, Michigan, 미국, 49201
- Allegiance Health
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Lansing, Michigan, 미국, 48912
- University of Michigan Health - Sparrow Lansing
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Livonia, Michigan, 미국, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Monroe, Michigan, 미국, 48162
- Mercy Memorial Hospital
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Monroe, Michigan, 미국, 48162
- Toledo Clinic Cancer Centers-Monroe
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Muskegon, Michigan, 미국, 49444
- Trinity Health Muskegon Hospital
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Niles, Michigan, 미국, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Pontiac, Michigan, 미국, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
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Port Huron, Michigan, 미국, 48060
- Lake Huron Medical Center
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Reed City, Michigan, 미국, 49677
- Corewell Health Reed City Hospital
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Saginaw, Michigan, 미국, 48601
- MyMichigan Medical Center Saginaw
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Saint Joseph, Michigan, 미국, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint Joseph, Michigan, 미국, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Traverse City, Michigan, 미국, 49684
- Munson Medical Center
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Warren, Michigan, 미국, 48093
- Henry Ford Health Warren Hospital
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Minnesota
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Burnsville, Minnesota, 미국, 55337
- Fairview Ridges Hospital
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Coon Rapids, Minnesota, 미국, 55433
- Mercy Hospital
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Duluth, Minnesota, 미국, 55805
- Essentia Health Cancer Center
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Duluth, Minnesota, 미국, 55805
- Essentia Health Saint Mary's Medical Center
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Duluth, Minnesota, 미국, 55805
- Miller-Dwan Hospital
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Edina, Minnesota, 미국, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, 미국, 55432
- Unity Hospital
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Hutchinson, Minnesota, 미국, 55350
- Hutchinson Area Health Care
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Maplewood, Minnesota, 미국, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, 미국, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, 미국, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, 미국, 55407
- Abbott-Northwestern Hospital
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Minneapolis, Minnesota, 미국, 55454
- Health Partners Inc
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New Ulm, Minnesota, 미국, 56073
- New Ulm Medical Center
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Robbinsdale, Minnesota, 미국, 55422
- North Memorial Medical Health Center
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic in Rochester
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Saint Louis Park, Minnesota, 미국, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Louis Park, Minnesota, 미국, 55416
- Metro Minnesota Community Oncology Research Consortium
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Saint Paul, Minnesota, 미국, 55101
- Regions Hospital
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Saint Paul, Minnesota, 미국, 55102
- United Hospital
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Shakopee, Minnesota, 미국, 55379
- Saint Francis Regional Medical Center
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Stillwater, Minnesota, 미국, 55082
- Lakeview Hospital
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Waconia, Minnesota, 미국, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, 미국, 56201
- Rice Memorial Hospital
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Woodbury, Minnesota, 미국, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Missouri
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Branson, Missouri, 미국, 65616
- Cox Cancer Center Branson
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Cape Girardeau, Missouri, 미국, 63703
- Mercy Cancer Center - Cape Girardeau
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Columbia, Missouri, 미국, 65212
- MU Health - University Hospital/Ellis Fischel Cancer Center
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Independence, Missouri, 미국, 64057
- Centerpoint Medical Center LLC
-
Jefferson City, Missouri, 미국, 65109
- MU Health Care Goldschmidt Cancer Center
-
Joplin, Missouri, 미국, 64804
- Mercy Hospital Joplin
-
Kansas City, Missouri, 미국, 64154
- University of Kansas Cancer Center - North
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Kansas City, Missouri, 미국, 64131
- The University of Kansas Cancer Center-South
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Kansas City, Missouri, 미국, 64111
- Saint Luke's Hospital of Kansas City
-
Kansas City, Missouri, 미국, 64132
- Research Medical Center
-
Kansas City, Missouri, 미국, 64118
- Heartland Hematology and Oncology Associates Incorporated
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Kansas City, Missouri, 미국, 64108
- University Health Truman Medical Center
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Lee's Summit, Missouri, 미국, 64064
- University of Kansas Cancer Center - Lee's Summit
-
Lee's Summit, Missouri, 미국, 64086
- Saint Luke's East - Lee's Summit
-
Liberty, Missouri, 미국, 64068
- Liberty Hospital
-
Rolla, Missouri, 미국, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Rolla, Missouri, 미국, 65401
- Phelps Health Delbert Day Cancer Institute
-
Saint Joseph, Missouri, 미국, 64506
- Heartland Regional Medical Center
-
Springfield, Missouri, 미국, 65804
- Cancer Research for the Ozarks NCORP
-
Springfield, Missouri, 미국, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, 미국, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, 미국, 63110
- Washington University School of Medicine
-
St Louis, Missouri, 미국, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, 미국, 63109
- Mercy Infusion Center - Chippewa
-
St Louis, Missouri, 미국, 63141
- Mercy Hospital Saint Louis
-
-
Montana
-
Billings, Montana, 미국, 59101
- Billings Clinic Cancer Center
-
Billings, Montana, 미국, 59101
- Saint Vincent Healthcare
-
Billings, Montana, 미국, 59102
- Montana Cancer Consortium NCORP
-
Bozeman, Montana, 미국, 59715
- Bozeman Health Deaconess Hospital
-
Butte, Montana, 미국, 59701
- Saint James Community Hospital and Cancer Treatment Center
-
Great Falls, Montana, 미국, 59405
- Benefis Sletten Cancer Institute
-
Helena, Montana, 미국, 59601
- Saint Peter's Community Hospital
-
Kalispell, Montana, 미국, 59901
- Logan Health Medical Center
-
Missoula, Montana, 미국, 59802
- Saint Patrick Hospital - Community Hospital
-
-
Nebraska
-
Lincoln, Nebraska, 미국, 68510
- Nebraska Cancer Research Center
-
Omaha, Nebraska, 미국, 68114
- Nebraska Methodist Hospital
-
Omaha, Nebraska, 미국, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, 미국, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, 미국, 68130
- Alegent Health Lakeside Hospital
-
Omaha, Nebraska, 미국, 68106
- Missouri Valley Cancer Consortium
-
-
Nevada
-
Henderson, Nevada, 미국, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, 미국, 89052
- Cancer and Blood Specialists-Henderson
-
Henderson, Nevada, 미국, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, 미국, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, 미국, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, 미국, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, 미국, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, 미국, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, 미국, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, 미국, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, 미국, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, 미국, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, 미국, 89106
- Cancer and Blood Specialists-Shadow
-
Las Vegas, Nevada, 미국, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, 미국, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, 미국, 89121
- Cancer Therapy and Integrative Medicine
-
Las Vegas, Nevada, 미국, 89128
- Cancer and Blood Specialists-Tenaya
-
Las Vegas, Nevada, 미국, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, 미국, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, 미국, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, 미국, 89120
- Nevada Cancer Research Foundation NCORP
-
Las Vegas, Nevada, 미국, 89128
- Oncology Las Vegas - Tenaya
-
Las Vegas, Nevada, 미국, 89183
- OptumCare Cancer Care at Fort Apache
-
-
New Hampshire
-
Lebanon, New Hampshire, 미국, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
-
New Jersey
-
Camden, New Jersey, 미국, 08103
- Cooper Hospital University Medical Center
-
New Brunswick, New Jersey, 미국, 08903
- Rutgers Cancer Institute of New Jersey
-
-
New Mexico
-
Albuquerque, New Mexico, 미국, 87106
- University of New Mexico Cancer Center
-
Las Cruces, New Mexico, 미국, 88011
- Memorial Medical Center-Las Cruces
-
-
New York
-
Glens Falls, New York, 미국, 12801
- Glens Falls Hospital
-
Rochester, New York, 미국, 14642
- University of Rochester
-
Syracuse, New York, 미국, 13210
- Syracuse Veterans Administration Medical Center
-
The Bronx, New York, 미국, 10461
- Montefiore Medical Center-Einstein Campus
-
The Bronx, New York, 미국, 10467
- Montefiore Medical Center - Moses Campus
-
-
North Carolina
-
Chapel Hill, North Carolina, 미국, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Goldsboro, North Carolina, 미국, 27534
- Wayne Memorial Hospital
-
Hendersonville, North Carolina, 미국, 28791
- Margaret R Pardee Memorial Hospital
-
Kinston, North Carolina, 미국, 28501
- ECU Health Oncology Kinston
-
Statesville, North Carolina, 미국, 28677
- Iredell Memorial Hospital
-
-
North Dakota
-
Fargo, North Dakota, 미국, 58103
- Essentia Health Cancer Center-South University Clinic
-
-
Ohio
-
Belpre, Ohio, 미국, 45714
- Strecker Cancer Center-Belpre
-
Bowling Green, Ohio, 미국, 43402
- Toledo Clinic Cancer Centers-Bowling Green
-
Chillicothe, Ohio, 미국, 45601
- Adena Regional Medical Center
-
Cincinnati, Ohio, 미국, 45242
- Oncology Hematology Care Inc-Blue Ash
-
Cincinnati, Ohio, 미국, 45202
- Oncology Hematology Care Inc-Eden Park
-
Cincinnati, Ohio, 미국, 45211
- Oncology Hematology Care Inc-Mercy West
-
Cincinnati, Ohio, 미국, 45230
- Oncology Hematology Care Inc-Anderson
-
Cincinnati, Ohio, 미국, 45236
- Oncology Hematology Care Inc-Kenwood
-
Cleveland, Ohio, 미국, 44106
- Case Western Reserve University
-
Columbus, Ohio, 미국, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, 미국, 43210
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, 미국, 43219
- The Mark H Zangmeister Center
-
Columbus, Ohio, 미국, 43214
- Columbus Oncology and Hematology Associates Inc
-
Columbus, Ohio, 미국, 43228
- Doctors Hospital
-
Columbus, Ohio, 미국, 43215
- Grant Medical Center
-
Columbus, Ohio, 미국, 43222
- Mount Carmel Health Center West
-
Columbus, Ohio, 미국, 43215
- Columbus NCI Community Oncology Research Program
-
Dayton, Ohio, 미국, 45406
- Good Samaritan Hospital - Dayton
-
Dayton, Ohio, 미국, 45409
- Miami Valley Hospital
-
Dayton, Ohio, 미국, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, 미국, 45459
- Dayton NCI Community Oncology Research Program
-
Delaware, Ohio, 미국, 43015
- Delaware Health Center-Grady Cancer Center
-
Delaware, Ohio, 미국, 43015
- Delaware Radiation Oncology
-
Delaware, Ohio, 미국, 43015
- Grady Memorial Hospital
-
Fairfield, Ohio, 미국, 45014
- Oncology Hematology Care Inc-Healthplex
-
Findlay, Ohio, 미국, 45840
- Blanchard Valley Hospital
-
Franklin, Ohio, 미국, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Greenville, Ohio, 미국, 45331
- Wayne Hospital
-
Kettering, Ohio, 미국, 45429
- Kettering Medical Center
-
Lancaster, Ohio, 미국, 43130
- Fairfield Medical Center
-
Lancaster, Ohio, 미국, 43130
- Lancaster Radiation Oncology
-
Lima, Ohio, 미국, 45804
- Lima Memorial Hospital
-
Marietta, Ohio, 미국, 45750
- Marietta Memorial Hospital
-
Maumee, Ohio, 미국, 43537
- Toledo Clinic Cancer Centers-Maumee
-
Maumee, Ohio, 미국, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
-
Mount Vernon, Ohio, 미국, 43050
- Knox Community Hospital
-
Newark, Ohio, 미국, 43055
- Licking Memorial Hospital
-
Newark, Ohio, 미국, 43055
- Newark Radiation Oncology
-
Oregon, Ohio, 미국, 43616
- Saint Charles Hospital
-
Oregon, Ohio, 미국, 43616
- Toledo Clinic Cancer Centers-Oregon
-
Portsmouth, Ohio, 미국, 45662
- Southern Ohio Medical Center
-
Springfield, Ohio, 미국, 45504
- Springfield Regional Medical Center
-
Sylvania, Ohio, 미국, 43560
- ProMedica Flower Hospital
-
Tiffin, Ohio, 미국, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, 미국, 43623
- Mercy Health - Saint Anne Hospital
-
Toledo, Ohio, 미국, 43623
- Toledo Clinic Cancer Centers-Toledo
-
Toledo, Ohio, 미국, 43614
- University of Toledo
-
Toledo, Ohio, 미국, 43617
- Toledo Community Hospital Oncology Program CCOP
-
Toledo, Ohio, 미국, 43608
- Mercy Health - Saint Vincent Hospital
-
Troy, Ohio, 미국, 45373
- Upper Valley Medical Center
-
Wauseon, Ohio, 미국, 43567
- Fulton County Health Center
-
Westerville, Ohio, 미국, 43081
- Saint Ann's Hospital
-
Zanesville, Ohio, 미국, 43701
- Genesis Healthcare System Cancer Care Center
-
-
Oklahoma
-
Lawton, Oklahoma, 미국, 73505
- Cancer Centers of Southwest Oklahoma Research
-
Oklahoma City, Oklahoma, 미국, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, 미국, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
-
-
Oregon
-
Clackamas, Oregon, 미국, 97015
- Clackamas Radiation Oncology Center
-
Milwaukie, Oregon, 미국, 97222
- Providence Milwaukie Hospital
-
Newberg, Oregon, 미국, 97132
- Providence Newberg Medical Center
-
Oregon City, Oregon, 미국, 97045
- Providence Willamette Falls Medical Center
-
Portland, Oregon, 미국, 97213
- Providence Portland Medical Center
-
Portland, Oregon, 미국, 97225
- Providence Saint Vincent Medical Center
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, 미국, 18015
- Saint Luke's University Hospital-Bethlehem Campus
-
Danville, Pennsylvania, 미국, 17822
- Geisinger Medical Center
-
Hazleton, Pennsylvania, 미국, 18201
- Geisinger Medical Center-Cancer Center Hazleton
-
Sayre, Pennsylvania, 미국, 18840
- Guthrie Medical Group PC-Robert Packer Hospital
-
State College, Pennsylvania, 미국, 16801
- Geisinger Medical Group
-
Wilkes-Barre, Pennsylvania, 미국, 18711
- Geisinger Wyoming Valley/Henry Cancer Center
-
Williamsport, Pennsylvania, 미국, 17701
- UPMC Susquehanna
-
-
South Carolina
-
Boiling Springs, South Carolina, 미국, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Florence, South Carolina, 미국, 29506
- McLeod Regional Medical Center
-
Greenville, South Carolina, 미국, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, 미국, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, 미국, 29605
- Prisma Health Cancer Institute - Butternut
-
Greenville, South Carolina, 미국, 29605
- Prisma Health Greenville Memorial Hospital
-
Greer, South Carolina, 미국, 29650
- Prisma Health Cancer Institute - Greer
-
Seneca, South Carolina, 미국, 29672
- Prisma Health Cancer Institute - Seneca
-
-
South Dakota
-
Rapid City, South Dakota, 미국, 57701
- Rapid City Regional Hospital
-
-
Texas
-
Dallas, Texas, 미국, 75246
- Baylor University Medical Center
-
Houston, Texas, 미국, 77030
- Houston Methodist Hospital
-
San Antonio, Texas, 미국, 78229
- University of Texas Health Science Center at San Antonio
-
-
Utah
-
American Fork, Utah, 미국, 84003
- American Fork Hospital / Huntsman Intermountain Cancer Center
-
Cedar City, Utah, 미국, 84720
- Sandra L Maxwell Cancer Center
-
Logan, Utah, 미국, 84321
- Logan Regional Hospital
-
Murray, Utah, 미국, 84107
- Intermountain Medical Center
-
Ogden, Utah, 미국, 84403
- McKay-Dee Hospital Center
-
Provo, Utah, 미국, 84604
- Utah Valley Regional Medical Center
-
Salt Lake City, Utah, 미국, 84106
- Utah Cancer Specialists-Salt Lake City
-
Salt Lake City, Utah, 미국, 84143
- LDS Hospital
-
St. George, Utah, 미국, 84770
- Saint George Regional Medical Center
-
-
Vermont
-
Bennington, Vermont, 미국, 05201
- Southwestern Vermont Medical Center
-
-
Virginia
-
Fredericksburg, Virginia, 미국, 22401
- Fredericksburg Oncology Inc
-
-
Washington
-
Vancouver, Washington, 미국, 98664
- PeaceHealth Southwest Medical Center
-
Vancouver, Washington, 미국, 98684
- Compass Oncology Vancouver
-
-
West Virginia
-
Huntington, West Virginia, 미국, 25701
- Edwards Comprehensive Cancer Center
-
-
Wisconsin
-
Chippewa Falls, Wisconsin, 미국, 54729
- Marshfield Clinic-Chippewa Center
-
Eau Claire, Wisconsin, 미국, 54701
- HSHS Sacred Heart Hospital
-
Eau Claire, Wisconsin, 미국, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Green Bay, Wisconsin, 미국, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, 미국, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Green Bay, Wisconsin, 미국, 54301-3526
- Green Bay Oncology at Saint Vincent Hospital
-
Madison, Wisconsin, 미국, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Manitowoc, Wisconsin, 미국, 54221
- Holy Family Memorial Hospital
-
Marshfield, Wisconsin, 미국, 54449
- Marshfield Medical Center-Marshfield
-
Marshfield, Wisconsin, 미국, 54449
- Marshfield Medical Center
-
Milwaukee, Wisconsin, 미국, 53226
- Medical College of Wisconsin
-
Minocqua, Wisconsin, 미국, 54548
- Marshfield Medical Center - Minocqua
-
New Richmond, Wisconsin, 미국, 54017
- Cancer Center of Western Wisconsin
-
Oconto Falls, Wisconsin, 미국, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Rhinelander, Wisconsin, 미국, 54501
- Saint Mary's Hospital
-
Rhinelander, Wisconsin, 미국, 54501
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
-
Rice Lake, Wisconsin, 미국, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, 미국, 53081
- HSHS Saint Nicholas Hospital
-
Stevens Point, Wisconsin, 미국, 54481
- Aspirus Cancer Care - Stevens Point
-
Wausau, Wisconsin, 미국, 54401
- Marshfield Clinic-Wausau Center
-
Weston, Wisconsin, 미국, 54476
- Marshfield Medical Center - Weston
-
Wisconsin Rapids, Wisconsin, 미국, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
Wyoming
-
Casper, Wyoming, 미국, 82609
- Rocky Mountain Oncology
-
Sheridan, Wyoming, 미국, 82801
- Welch Cancer Center
-
-
-
-
Alberta
-
Calgary, Alberta, 캐나다, T2N 5G2
- Arthur J E Child Comprehensive Cancer Centre
-
-
British Columbia
-
Vancouver, British Columbia, 캐나다, V5Z 4E6
- BCCA-Vancouver Cancer Centre
-
-
New Brunswick
-
Moncton, New Brunswick, 캐나다, E1C 8X3
- The Vitalite Health Network - Dr Leon Richard Oncology Centre
-
-
Nova Scotia
-
Halifax, Nova Scotia, 캐나다, B3H 2Y9
- QEII Health Sciences Centre/Nova Scotia Health Authority
-
-
Ontario
-
Hamilton, Ontario, 캐나다, L8V 5C2
- Juravinski Cancer Centre at Hamilton Health Sciences
-
Kitchener, Ontario, 캐나다, N2G 1G3
- Waterloo Regional Health Network
-
Ottawa, Ontario, 캐나다, K1H 8L6
- Ottawa Hospital and Cancer Center-General Campus
-
Toronto, Ontario, 캐나다, M5G 2M9
- University Health Network-Princess Margaret Hospital
-
-
Quebec
-
Montreal, Quebec, 캐나다, H2X 3E4
- CHUM - Centre Hospitalier de l'Universite de Montreal
-
-
Saskatchewan
-
Regina, Saskatchewan, 캐나다, S4T 7T1
- Allan Blair Cancer Centre
-
Saskatoon, Saskatchewan, 캐나다, S7N 4H4
- Saskatoon Cancer Centre
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
-
Low- or intermediate-grade neuroendocrine carcinoma, including the following subtypes: carcinoid tumor, low- to intermediate-grade or well- to moderately-differentiated neuroendocrine carcinoma or tumor, atypical carcinoid tumor; documentation from a primary tumor or metastatic site is sufficient; patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid tumor, or goblet cell carcinoid tumor are not eligible
-
Locally unresectable or metastatic carcinoid tumors
-
Patients must have histologic documentation or clinical evidence of a carcinoid tumor of primary site (including foregut, midgut, hindgut or other non-pancreatic site); tumors of unknown primary site are eligible provided the treating physician does not suspect medullary thyroid cancer, pancreatic neuroendocrine tumor, paraganglioma, or pheochromocytoma; unknown primary tumors will be classified as small bowel tumors for the purpose of stratification; functional (associated with a clinical syndrome) or nonfunctional tumors are allowed; target lesions must have shown disease progression if therapy included peptide receptor radiotherapy (PRRT) and PRRT must be completed at least 8 weeks prior to registration
-
Radiological evidence for progressive disease (measurable or non-measurable) within 12 months prior to registration; patients who have received anti-tumor therapy during the past 12 months (including octreotide analogs) must have had radiological documentation of progression of disease while on or after receiving therapy
-
No known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage; patients with lesions infiltrating major pulmonary vessels (contiguous tumor and vessels) are excluded; however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is acceptable (computed tomography [CT] with contrast is strongly recommended to evaluate such lesions); patients with large protruding endobronchial lesions in the main or lobar bronchi are excluded; however, endobronchial lesions in the segmented bronchi are allowed
-
Patients must have measurable disease per RECIST 1.1 by computed tomography (CT) scan or magnetic resonance imaging (MRI); lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as >= 1 cm with CT or MRI (or >= 1.5 cm for lymph nodes); index lesions for the purpose of RECIST 1.1 measurements will not be selected from within the radiation therapy treatment field; however, if there is evidence of disease progression within the radiation treatment field, measurement of the progressing lesions will be documented
-
No prior treatment with an inhibitor of vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR)
-
Prior treatment (somatostatin analogs excepted) must be completed at least 2 weeks prior to registration; in addition, prior treatment (somatostatin analogs excepted) must be completed at least 4 weeks prior to initiation of study drug; treatment-related toxicities must have improved to =< grade 1 prior to registration, with the exception of alopecia
-
Concurrent use of somatostatin analogs (SSTa) is allowed, provided that the patient is on a stable dose for at least two months and progressive disease on somatostatin analog has been documented; progression on octreotide is required for patients with tumors arising in the midgut
-
Prior treatment with embolization (including bland embolization, chemoembolization, and selective internal radiation therapy) or ablative therapies is allowed if measurable disease remains outside of the treated area or there is documented disease progression in a treated site; there is no limit on the prior number of procedures; prior liver-directed or other ablative treatment must be completed at least 8 weeks prior to registration; index lesions for the purpose of RECIST 1.1 measurements will not be selected from within the radiation therapy treatment field; however, if there is evidence of disease progression within the radiation treatment field, measurement of the progressing lesions will be documented
-
Patients should have completed any major surgery >= 4 weeks prior to registration and must have completed any minor surgery >= 2 weeks prior to registration; patients must have fully recovered from the procedure
- The following are examples of procedures considered to be minor: port placement, laparoscopy, thoracoscopy, bronchoscopy, mediastinoscopy, skin biopsies, incisional biopsies, imaging-guided biopsy for diagnostic purposes, and dental extraction procedures
- Insertion of a vascular access device, thoracentesis, paracentesis, and endoscopic ultrasonographic procedures are not considered to be major or minor surgeries
-
No concurrent condition resulting in immune compromise, including chronic treatment with corticosteroids or other immunosuppressive agents
-
No clinical evidence of central nervous system (CNS) metastases (including carcinomatous meningitis) at baseline, with the exception of those patients who have previously-treated CNS metastases (surgery +/- radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) had no requirement for steroids or enzyme-inducing anticonvulsants within 6 months prior to registration
-
No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to registration
-
No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 28 days prior to registration including, but not limited to:
- Active peptic ulcer
- Known endoluminal metastatic lesion(s) with history of bleeding
- Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other gastrointestinal conditions with increased risk of perforation
-
No history of serious (i.e., requiring active medical therapy with medication or medical device under the supervision of a physician) non-healing wound, ulcer, trauma, or bone fracture within 28 days prior to study entry
-
Patients with a history of hypertension must have blood pressure that is adequately controlled on antihypertensives; (< 140/90 mm Hg)
-
No symptomatic congestive heart failure (New York Heart Association class II, III, or IV) within 6 months prior to registration
-
No arterial thrombotic events within 6 months of registration, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, myocardial infarction (MI), or unstable angina or angina requiring surgical or medical intervention in 6 months prior to registration; patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) are ineligible; patients who have experienced a deep venous thrombosis or pulmonary embolus within 6 months prior to registration must be on stable therapeutic anticoagulation for at least 6 weeks prior to enrollment of this study
-
Patients on therapeutic anticoagulation with low molecular weight heparins, fondaparinux, rivaroxaban or warfarin are eligible, provided that they are on a stable dose of anticoagulants; patients who are currently receiving antiplatelet therapy of prasugrel or clopidogrel or antiaggregation agents (e.g., eptifibatide, epoprostenol, dipyridamole) or low doses of acetylsalicylic acid (up to 100 mg daily) are also eligible
-
No ongoing cardiac dysrhythmias, atrial fibrillation, or prolongation of corrected QT (QTc) interval to > 480 msec
-
No evidence of active bleeding, bleeding diathesis, or hemoptysis (>= 1/2 teaspoon of red blood) within 8 weeks prior to registration
-
No currently unstable angina and/or uncontrolled cardiac arrhythmias
-
Patients with symptomatic peripheral vascular disease are ineligible
-
Ejection fraction on echocardiogram (Echo) or multi gated acquisition scan (MUGA) > 50%
-
Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) is not allowed on this trial; patients on strong CYP3A4 inhibitors must discontinue the drug 14 days prior to the start of study treatment
-
Women must not be pregnant or nursing; women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to registration; women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL)
-
Age >= 18 years of age
-
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
-
Granulocytes >= 1,500/mcL
-
Platelets >= 100,000/mcL
-
International normalized ratio (INR) =< 1.2 X upper limit of normal (ULN); only required for patients receiving anticoagulant therapy; patients are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation
-
QTc =< 480 msecs
-
Thyroid stimulating hormone (TSH) within normal limits (WNL); medications for thyroid dysfunction are allowed as long as TSH is normal at registration; in patients with abnormal TSH, if the free thyroxine (free T4) and free thyroxine index (FTI) are normal and patient is clinically euthyroid, patient is eligible
-
Bilirubin =< 1.5 x ULN
-
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) & alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN; concomitant elevations in bilirubin and AST/ALT above 1.0 X ULN are NOT permitted; also, if liver metastases are present, AST & ALT =< 5 x ULN is allowed
-
Serum creatinine =< 1.5 x ULN
-
Urine protein to creatinine ratio < 1, or, 24-hour urine protein < 1 g; if urine protein to creatinine (UPC) >= 1, then a 24-hour urine protein must be assessed; patients must have a 24-hour urine protein value < 1 g to be eligible; use of urine dipstick for renal function assessment is not acceptable
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Arm I (pazopanib hydrochloride)
Patients receive pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening. Patients also undergo CT, MRI, and chest x-ray throughout the trial. Patients may optionally undergo blood sample collection during screening and on study. |
Correlative studies Ancillary studies
다른 이름들:
Undergo blood sample collection
다른 이름들:
Undergo CT
다른 이름들:
Undergo MRI
다른 이름들:
Given PO
다른 이름들:
Undergo ECHO
다른 이름들:
Undergo MUGA
다른 이름들:
Undergo chest x-ray
다른 이름들:
|
|
위약 비교기: Arm II (placebo)
Patients receive placebo PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I. Patients undergo ECHO or MUGA during screening. Patients also undergo CT, MRI, and chest x-ray throughout the trial. Patients may optionally undergo blood sample collection during screening and on study. |
Correlative studies Ancillary studies
다른 이름들:
Undergo blood sample collection
다른 이름들:
Undergo CT
다른 이름들:
Undergo MRI
다른 이름들:
Given PO Undergo ECHO
다른 이름들:
Undergo MUGA
다른 이름들:
Undergo chest x-ray
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-free Survival (PFS)
기간: From date of patient entry until documented progression of disease or death from any cause, assessed up to 5 years
|
PFS will be measured from date of patient entry until documented progression of disease as determined by central review or death from any cause. If a patient does not have a documented date of progression or death, then PFS will be censored at the date of last adequate assessment. PFS will be estimated within treatment arm using the Kaplan-Meier method. Progression is defined as any new lesion or increase by ≥20% of previously involved sites from nadir based on RECIST criteria. |
From date of patient entry until documented progression of disease or death from any cause, assessed up to 5 years
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Best Response
기간: Up to 5 years
|
The best response per RECIST 1.1 criteria of participants receiving randomized treatment assignment. Complete response (CR): Disappearance of all evidence of disease, Partial response (PR): Regression of measurable disease and no new sites, Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study. Progressive disease (PD): Any new lesion or increase by ≥20% of previously involved sites from nadir. Note that those considered evaluable for best response here were those who had disease measurements while on treatment. Those who discontinued therapy early prior to a disease evaluation were not included. |
Up to 5 years
|
|
Overall Survival
기간: From randomization until death from any cause, assessed up to 5 years
|
Overall survival (OS) will be measured from randomization until death from any cause. A patient who is alive at the time of the statistical analysis will be considered censored at the last date of known contact. OS will be estimated by the Kaplan-Meier method within each treatment arm. |
From randomization until death from any cause, assessed up to 5 years
|
|
Duration of Response for the Subset of Patients With a Confirmed Complete Response or Partial Response
기간: From first documented evidence of complete response or partial response until first documented disease progression or death from any cause, assessed up to 5 years
|
Duration of response is defined as the time from documented response to time of progression and/or death. This time-to-event outcome will be summarized descriptively using the methods of Kaplan and Meier to characterize the cohort and distribution of this outcome. |
From first documented evidence of complete response or partial response until first documented disease progression or death from any cause, assessed up to 5 years
|
|
Time to Treatment Failure
기간: From randomization until termination of protocol therapy for any reason including progression of disease, adverse events, and death, assessed up to 5 years
|
Time to treatment failure is defined as the time from randomization to the time that treatment is terminated, including the reasons of disease progression, adverse events, withdrawal from study, or death. This time-to-event outcome will be evaluated using the methods of Kaplan and Meier. |
From randomization until termination of protocol therapy for any reason including progression of disease, adverse events, and death, assessed up to 5 years
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to Second Progression for Patients Who Crossover From Placebo to Active Therapy
기간: Up to 5 years
|
Time to second progression will be defined as the progression free survival from crossover re-registration to documented progression of disease as determined by central review or death from any cause. If a patient does not have a documented date of progression or death, then PFS will be censored at the date of last adequate assessment. PFS will be estimated within treatment arm using the Kaplan-Meier method. Progression is defined as any new lesion or increase by ≥20% of previously involved sites from nadir based on RECIST criteria. |
Up to 5 years
|
|
PFS Within Each Arm
기간: At 6 months
|
Kaplan-Meier methods will be used including calculations of 95% confidence intervals. |
At 6 months
|
|
Biochemical Response
기간: Up to 5 years
|
Biochemical response (for chromogranin A, defined as a decrease of 50% or more in chromogranin A levels from baseline, and for 5-hydroxyindoleacetic acid [5-HIAA], defined as a decrease of 50% or more in urinary 5-HIAA levels from baseline) will be compared between treatment arms among patients with elevated baseline levels of serum chromogranin A (CGA) and 5-HIAA. |
Up to 5 years
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Emily K Bergsland, Alliance for Clinical Trials in Oncology
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- NCI-2013-00831
- U10CA180821 (미국 NIH 보조금/계약)
- U10CA180830 (미국 NIH 보조금/계약)
- U10CA031946 (미국 NIH 보조금/계약)
- NCI-2013-00831 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- ALLIANCE A021202
- CALGB-A021202
- A021202 (기타 식별자: CTEP)
- A021202 (기타 식별자: Alliance for Clinical Trials in Oncology)
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