- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01841736
Pazopanibhydroklorid i behandling av pasienter med progressive karsinoidsvulster
Prospektiv randomisert fase II-studie av Pazopanib (NSC # 737754) versus placebo hos pasienter med progressive karsinoidsvulster
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.
Studieoversikt
Status
Forhold
- Metastatisk fordøyelsessystem Nevroendokrin svulst G1
- Tilbakevendende fordøyelsessystemet nevroendokrin svulst G1
- Regionalt fordøyelsessystem nevroendokrin svulst G1
- Metastatisk nevroendokrin svulst
- Midgut Nevroendocrine Tumor G1
- Formaks nevroendokrin svulst
- Hindgut nevroendokrin svulst
- Nevroendokrin svulst G2
Intervensjon / Behandling
- Annen: Laboratory Biomarker Analysis
- Annen: Quality-of-Life Assessment
- Fremgangsmåte: Biospecimen Collection
- Fremgangsmåte: Computed Tomography
- Fremgangsmåte: Magnetic Resonance Imaging
- Legemiddel: Pazopanib Hydrochloride
- Annen: Placebo Administration
- Fremgangsmåte: Echocardiography Test
- Fremgangsmåte: Multigated Acquisition Scan
- Fremgangsmåte: X-Ray Imaging
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 5G2
- Arthur J E Child Comprehensive Cancer Centre
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 4E6
- BCCA-Vancouver Cancer Centre
-
-
New Brunswick
-
Moncton, New Brunswick, Canada, E1C 8X3
- The Vitalite Health Network - Dr Leon Richard Oncology Centre
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 2Y9
- QEII Health Sciences Centre/Nova Scotia Health Authority
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre at Hamilton Health Sciences
-
Kitchener, Ontario, Canada, N2G 1G3
- Waterloo Regional Health Network
-
Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital and Cancer Center-General Campus
-
Toronto, Ontario, Canada, M5G 2M9
- University Health Network-Princess Margaret Hospital
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 3E4
- CHUM - Centre Hospitalier de l'Universite de Montreal
-
-
Saskatchewan
-
Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
-
Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
-
-
-
-
Alaska
-
Anchorage, Alaska, Forente stater, 99508
- Alaska Breast Care and Surgery LLC
-
Anchorage, Alaska, Forente stater, 99508
- Alaska Women's Cancer Care
-
Anchorage, Alaska, Forente stater, 99508
- Anchorage Oncology Centre
-
Anchorage, Alaska, Forente stater, 99508
- Katmai Oncology Group
-
Anchorage, Alaska, Forente stater, 99508
- Providence Alaska Medical Center
-
-
Arizona
-
Scottsdale, Arizona, Forente stater, 85259
- Mayo Clinic in Arizona
-
-
California
-
Anaheim, California, Forente stater, 92806
- Kaiser Permanente-Anaheim
-
Baldwin Park, California, Forente stater, 91706
- Kaiser Permanente-Baldwin Park
-
Fontana, California, Forente stater, 92335
- Kaiser Permanente-Fontana
-
Harbor City, California, Forente stater, 90710
- Kaiser Permanente South Bay
-
Irvine, California, Forente stater, 92618
- Kaiser Permanente-Irvine
-
Los Angeles, California, Forente stater, 90033
- USC / Norris Comprehensive Cancer Center
-
Los Angeles, California, Forente stater, 90048
- Cedars-Sinai Medical Center
-
Los Angeles, California, Forente stater, 90027
- Kaiser Permanente Los Angeles Medical Center
-
Los Angeles, California, Forente stater, 90034
- Kaiser Permanente West Los Angeles
-
Los Angeles, California, Forente stater, 90033
- Los Angeles General Medical Center
-
Palo Alto, California, Forente stater, 94304
- Stanford Cancer Institute Palo Alto
-
Palo Alto, California, Forente stater, 94301
- Palo Alto Medical Foundation Health Care
-
Panorama City, California, Forente stater, 91402
- Kaiser Permanente - Panorama City
-
Riverside, California, Forente stater, 92505
- Kaiser Permanente-Riverside
-
San Diego, California, Forente stater, 92120
- Kaiser Permanente-San Diego Zion
-
San Diego, California, Forente stater, 92108
- Kaiser Permanente-Rio San Diego
-
San Francisco, California, Forente stater, 94158
- UCSF Medical Center-Mission Bay
-
San Francisco, California, Forente stater, 94115
- UCSF Medical Center-Mount Zion
-
San Marcos, California, Forente stater, 92078
- Kaiser Permanente-San Marcos
-
Santa Cruz, California, Forente stater, 95065
- Palo Alto Medical Foundation-Santa Cruz
-
Sunnyvale, California, Forente stater, 94086
- Palo Alto Medical Foundation-Sunnyvale
-
Woodland Hills, California, Forente stater, 91367
- Kaiser Permanente-Woodland Hills
-
-
Colorado
-
Aurora, Colorado, Forente stater, 80012
- The Medical Center of Aurora
-
Boulder, Colorado, Forente stater, 80303
- Boulder Community Foothills Hospital
-
Boulder, Colorado, Forente stater, 80304
- Rocky Mountain Cancer Centers-Boulder
-
Colorado Springs, Colorado, Forente stater, 80907
- Penrose-Saint Francis Healthcare
-
Colorado Springs, Colorado, Forente stater, 80907
- Rocky Mountain Cancer Centers-Penrose
-
Denver, Colorado, Forente stater, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
-
Denver, Colorado, Forente stater, 80220
- Rose Medical Center
-
Denver, Colorado, Forente stater, 80218
- Rocky Mountain Cancer Centers-Midtown
-
Denver, Colorado, Forente stater, 80220
- Rocky Mountain Cancer Centers-Rose
-
Denver, Colorado, Forente stater, 80218
- Colorado Blood Cancer Institute
-
Denver, Colorado, Forente stater, 80222
- Western States Cancer Research NCORP
-
Denver, Colorado, Forente stater, 80218
- Saint Joseph Hospital - Cancer Centers of Colorado
-
Denver, Colorado, Forente stater, 80210
- AdventHealth Porter
-
Durango, Colorado, Forente stater, 81301
- Mercy Medical Center
-
Englewood, Colorado, Forente stater, 80113
- Mountain Blue Cancer Care Center - Swedish
-
Englewood, Colorado, Forente stater, 80113
- Swedish Medical Center
-
Fort Collins, Colorado, Forente stater, 80524
- Poudre Valley Hospital
-
Golden, Colorado, Forente stater, 80401
- Mountain Blue Cancer Care Center
-
Greeley, Colorado, Forente stater, 80631
- Banner North Colorado Medical Center
-
Greenwood Village, Colorado, Forente stater, 80111
- Rocky Mountain Cancer Centers-Greenwood Village
-
Lakewood, Colorado, Forente stater, 80228
- Rocky Mountain Cancer Centers-Lakewood
-
Lakewood, Colorado, Forente stater, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
-
Littleton, Colorado, Forente stater, 80122
- AdventHealth Littleton
-
Lone Tree, Colorado, Forente stater, 80124
- Sky Ridge Medical Center
-
Lone Tree, Colorado, Forente stater, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
-
Longmont, Colorado, Forente stater, 80501
- Longmont United Hospital
-
Longmont, Colorado, Forente stater, 80501
- Rocky Mountain Cancer Centers-Longmont
-
Loveland, Colorado, Forente stater, 80539
- Banner North Colorado Medical Center - Loveland Campus
-
Parker, Colorado, Forente stater, 80138
- Rocky Mountain Cancer Centers-Parker
-
Parker, Colorado, Forente stater, 80138
- AdventHealth Parker
-
Pueblo, Colorado, Forente stater, 81004
- Saint Mary Corwin Medical Center
-
Pueblo, Colorado, Forente stater, 81008
- Rocky Mountain Cancer Centers - Pueblo
-
Wheat Ridge, Colorado, Forente stater, 80401
- Intermountain Health Lutheran Hospital
-
-
Connecticut
-
Hartford, Connecticut, Forente stater, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
-
-
Delaware
-
Lewes, Delaware, Forente stater, 19958
- Beebe Medical Center
-
Newark, Delaware, Forente stater, 19713
- Helen F Graham Cancer Center
-
Newark, Delaware, Forente stater, 19713
- Delaware Clinical and Laboratory Physicians PA
-
Newark, Delaware, Forente stater, 19713
- Medical Oncology Hematology Consultants PA
-
Newark, Delaware, Forente stater, 19718
- Christiana Care Health System-Christiana Hospital
-
Rehoboth Beach, Delaware, Forente stater, 19971
- Beebe Health Campus
-
Seaford, Delaware, Forente stater, 19973
- TidalHealth Nanticoke / Allen Cancer Center
-
Wilmington, Delaware, Forente stater, 19801
- Christiana Care Health System-Wilmington Hospital
-
-
Florida
-
Tampa, Florida, Forente stater, 33612
- Moffitt Cancer Center
-
-
Georgia
-
Columbus, Georgia, Forente stater, 31904
- John B Amos Cancer Center
-
Savannah, Georgia, Forente stater, 31404
- Memorial Health University Medical Center
-
-
Hawaii
-
Honolulu, Hawaii, Forente stater, 96813
- Queen's Medical Center
-
Honolulu, Hawaii, Forente stater, 96813
- Hawaii Cancer Care Inc - Waterfront Plaza
-
Honolulu, Hawaii, Forente stater, 96813
- Straub Clinic and Hospital
-
Honolulu, Hawaii, Forente stater, 96813
- University of Hawaii Cancer Center
-
Honolulu, Hawaii, Forente stater, 96817
- Hawaii Cancer Care Inc-Liliha
-
Honolulu, Hawaii, Forente stater, 96817
- Queen's Cancer Center - Kuakini
-
Honolulu, Hawaii, Forente stater, 96826
- Kapiolani Medical Center for Women and Children
-
Kailua, Hawaii, Forente stater, 96734
- Castle Medical Center
-
Lihue, Hawaii, Forente stater, 96766
- Wilcox Memorial Hospital and Kauai Medical Clinic
-
‘Aiea, Hawaii, Forente stater, 96701
- Pali Momi Medical Center
-
‘Aiea, Hawaii, Forente stater, 96701
- Queen's Cancer Center - Pearlridge
-
-
Idaho
-
Boise, Idaho, Forente stater, 83706
- Saint Alphonsus Cancer Care Center-Boise
-
Post Falls, Idaho, Forente stater, 83854
- Kootenai Clinic Cancer Services - Post Falls
-
-
Illinois
-
Bloomington, Illinois, Forente stater, 61704
- Illinois CancerCare-Bloomington
-
Canton, Illinois, Forente stater, 61520
- Illinois CancerCare-Canton
-
Carthage, Illinois, Forente stater, 62321
- Illinois CancerCare-Carthage
-
Chicago, Illinois, Forente stater, 60611
- Northwestern University
-
Chicago, Illinois, Forente stater, 60637
- University of Chicago Comprehensive Cancer Center
-
Decatur, Illinois, Forente stater, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, Forente stater, 62526
- Cancer Care Specialists of Illinois - Decatur
-
Eureka, Illinois, Forente stater, 61530
- Illinois CancerCare-Eureka
-
Galesburg, Illinois, Forente stater, 61401
- Illinois CancerCare-Galesburg
-
Harvey, Illinois, Forente stater, 60426
- Ingalls Memorial Hospital
-
Kewanee, Illinois, Forente stater, 61443
- Illinois CancerCare-Kewanee Clinic
-
Macomb, Illinois, Forente stater, 61455
- Illinois CancerCare-Macomb
-
Maywood, Illinois, Forente stater, 60153
- Loyola University Medical Center
-
Mount Vernon, Illinois, Forente stater, 62864
- SSM Health Good Samaritan
-
Ottawa, Illinois, Forente stater, 61350
- Illinois CancerCare-Ottawa Clinic
-
Pekin, Illinois, Forente stater, 61554
- Illinois CancerCare-Pekin
-
Peoria, Illinois, Forente stater, 61615
- Illinois CancerCare-Peoria
-
Peru, Illinois, Forente stater, 61354
- Illinois CancerCare-Peru
-
Princeton, Illinois, Forente stater, 61356
- Illinois CancerCare-Princeton
-
-
Indiana
-
Elkhart, Indiana, Forente stater, 46515
- Elkhart General Hospital
-
Elkhart, Indiana, Forente stater, 46514
- Michiana Hematology Oncology PC-Elkhart
-
Elkhart, Indiana, Forente stater, 46514-2098
- Elkhart Clinic
-
Indianapolis, Indiana, Forente stater, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
-
Kokomo, Indiana, Forente stater, 46904
- Community Howard Regional Health
-
La Porte, Indiana, Forente stater, 46350
- IU Health La Porte Hospital
-
Mishawaka, Indiana, Forente stater, 46545
- Michiana Hematology Oncology PC-Mishawaka
-
Mishawaka, Indiana, Forente stater, 46545
- Saint Joseph Regional Medical Center-Mishawaka
-
Plymouth, Indiana, Forente stater, 46563
- Michiana Hematology Oncology PC-Plymouth
-
Richmond, Indiana, Forente stater, 47374
- Reid Health
-
South Bend, Indiana, Forente stater, 46601
- Memorial Hospital of South Bend
-
South Bend, Indiana, Forente stater, 46628
- Northern Indiana Cancer Research Consortium
-
South Bend, Indiana, Forente stater, 46617
- South Bend Clinic
-
Westville, Indiana, Forente stater, 46391
- Michiana Hematology Oncology PC-Westville
-
-
Iowa
-
Ames, Iowa, Forente stater, 50010
- Mary Greeley Medical Center
-
Ames, Iowa, Forente stater, 50010
- McFarland Clinic - Ames
-
Bettendorf, Iowa, Forente stater, 52722
- University of Iowa Healthcare Cancer Services Quad Cities
-
Boone, Iowa, Forente stater, 50036
- McFarland Clinic - Boone
-
Cedar Rapids, Iowa, Forente stater, 52403
- Mercy Hospital
-
Cedar Rapids, Iowa, Forente stater, 52403
- Oncology Associates at Mercy Medical Center
-
Clive, Iowa, Forente stater, 50325
- Mercy Cancer Center-West Lakes
-
Clive, Iowa, Forente stater, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
-
Des Moines, Iowa, Forente stater, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, Forente stater, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Forente stater, 50316
- Iowa Lutheran Hospital
-
Des Moines, Iowa, Forente stater, 50309
- Iowa-Wide Oncology Research Coalition NCORP
-
Des Moines, Iowa, Forente stater, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
-
Des Moines, Iowa, Forente stater, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
Iowa City, Iowa, Forente stater, 52242
- University of Iowa/Holden Comprehensive Cancer Center
-
Jefferson, Iowa, Forente stater, 50129
- McFarland Clinic - Jefferson
-
Marshalltown, Iowa, Forente stater, 50158
- McFarland Clinic - Marshalltown
-
Sioux City, Iowa, Forente stater, 51101
- Siouxland Regional Cancer Center
-
Sioux City, Iowa, Forente stater, 51102
- Mercy Medical Center-Sioux City
-
Sioux City, Iowa, Forente stater, 51104
- Saint Luke's Regional Medical Center
-
West Des Moines, Iowa, Forente stater, 50266-7700
- Methodist West Hospital
-
West Des Moines, Iowa, Forente stater, 50266
- Mercy Medical Center-West Lakes
-
-
Kansas
-
Emporia, Kansas, Forente stater, 66801
- Newman Regional Health
-
Garden City, Kansas, Forente stater, 67846
- Saint Catherine Hospital
-
Great Bend, Kansas, Forente stater, 67530
- Saint Rose Ambulatory and Surgery Center
-
Hays, Kansas, Forente stater, 67601
- HaysMed
-
Kansas City, Kansas, Forente stater, 66160
- University of Kansas Cancer Center
-
Kansas City, Kansas, Forente stater, 66112
- University of Kansas Cancer Center-West
-
Olathe, Kansas, Forente stater, 66061
- The University of Kansas Cancer Center - Olathe
-
Overland Park, Kansas, Forente stater, 66210
- University of Kansas Cancer Center-Overland Park
-
Overland Park, Kansas, Forente stater, 66209
- Menorah Medical Center
-
Overland Park, Kansas, Forente stater, 66213
- Saint Luke's South Hospital
-
Pittsburg, Kansas, Forente stater, 66762
- Mercy Hospital Pittsburg
-
Prairie Village, Kansas, Forente stater, 66208
- Kansas City NCI Community Oncology Research Program
-
Salina, Kansas, Forente stater, 67401
- Salina Regional Health Center
-
Topeka, Kansas, Forente stater, 66606
- University of Kansas Health System Saint Francis Campus
-
Wichita, Kansas, Forente stater, 67214
- Cancer Center of Kansas - Wichita
-
-
Kentucky
-
Crestview Hills, Kentucky, Forente stater, 41017
- Oncology Hematology Care Inc-Crestview
-
Elizabethtown, Kentucky, Forente stater, 42701
- Baptist Health Hardin
-
Lexington, Kentucky, Forente stater, 40503
- Baptist Health Lexington
-
-
Louisiana
-
Baton Rouge, Louisiana, Forente stater, 70809
- Ochsner Health Center-Summa
-
New Orleans, Louisiana, Forente stater, 70121
- Ochsner Medical Center Jefferson
-
-
Michigan
-
Adrian, Michigan, Forente stater, 49221
- Bixby Medical Center
-
Adrian, Michigan, Forente stater, 49221
- Hickman Cancer Center
-
Ann Arbor, Michigan, Forente stater, 48106
- Michigan Cancer Research Consortium NCORP
-
Ann Arbor, Michigan, Forente stater, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
-
Battle Creek, Michigan, Forente stater, 49017
- Bronson Battle Creek
-
Dearborn, Michigan, Forente stater, 48124
- Corewell Health Dearborn Hospital
-
Detroit, Michigan, Forente stater, 48236
- Henry Ford Health Saint John Hospital
-
Escanaba, Michigan, Forente stater, 49829
- OSF Saint Francis Hospital and Medical Group
-
Flint, Michigan, Forente stater, 48503
- Hurley Medical Center
-
Flint, Michigan, Forente stater, 48503
- Genesys Hurley Cancer Institute
-
Grand Rapids, Michigan, Forente stater, 49503
- Cancer Research Consortium of West Michigan NCORP
-
Grand Rapids, Michigan, Forente stater, 49503
- Trinity Health Grand Rapids Hospital
-
Grand Rapids, Michigan, Forente stater, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Jackson, Michigan, Forente stater, 49201
- Allegiance Health
-
Lansing, Michigan, Forente stater, 48912
- University of Michigan Health - Sparrow Lansing
-
Livonia, Michigan, Forente stater, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Monroe, Michigan, Forente stater, 48162
- Mercy Memorial Hospital
-
Monroe, Michigan, Forente stater, 48162
- Toledo Clinic Cancer Centers-Monroe
-
Muskegon, Michigan, Forente stater, 49444
- Trinity Health Muskegon Hospital
-
Niles, Michigan, Forente stater, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
-
Pontiac, Michigan, Forente stater, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Port Huron, Michigan, Forente stater, 48060
- Lake Huron Medical Center
-
Reed City, Michigan, Forente stater, 49677
- Corewell Health Reed City Hospital
-
Saginaw, Michigan, Forente stater, 48601
- MyMichigan Medical Center Saginaw
-
Saint Joseph, Michigan, Forente stater, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Saint Joseph, Michigan, Forente stater, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
-
Traverse City, Michigan, Forente stater, 49684
- Munson Medical Center
-
Warren, Michigan, Forente stater, 48093
- Henry Ford Health Warren Hospital
-
-
Minnesota
-
Burnsville, Minnesota, Forente stater, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, Forente stater, 55433
- Mercy Hospital
-
Duluth, Minnesota, Forente stater, 55805
- Essentia Health Cancer Center
-
Duluth, Minnesota, Forente stater, 55805
- Essentia Health Saint Mary's Medical Center
-
Duluth, Minnesota, Forente stater, 55805
- Miller-Dwan Hospital
-
Edina, Minnesota, Forente stater, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, Forente stater, 55432
- Unity Hospital
-
Hutchinson, Minnesota, Forente stater, 55350
- Hutchinson Area Health Care
-
Maplewood, Minnesota, Forente stater, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, Forente stater, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, Forente stater, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Forente stater, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, Forente stater, 55454
- Health Partners Inc
-
New Ulm, Minnesota, Forente stater, 56073
- New Ulm Medical Center
-
Robbinsdale, Minnesota, Forente stater, 55422
- North Memorial Medical Health Center
-
Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic in Rochester
-
Saint Louis Park, Minnesota, Forente stater, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Louis Park, Minnesota, Forente stater, 55416
- Metro Minnesota Community Oncology Research Consortium
-
Saint Paul, Minnesota, Forente stater, 55101
- Regions Hospital
-
Saint Paul, Minnesota, Forente stater, 55102
- United Hospital
-
Shakopee, Minnesota, Forente stater, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, Forente stater, 55082
- Lakeview Hospital
-
Waconia, Minnesota, Forente stater, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Forente stater, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Forente stater, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
-
Missouri
-
Branson, Missouri, Forente stater, 65616
- Cox Cancer Center Branson
-
Cape Girardeau, Missouri, Forente stater, 63703
- Mercy Cancer Center - Cape Girardeau
-
Columbia, Missouri, Forente stater, 65212
- MU Health - University Hospital/Ellis Fischel Cancer Center
-
Independence, Missouri, Forente stater, 64057
- Centerpoint Medical Center LLC
-
Jefferson City, Missouri, Forente stater, 65109
- MU Health Care Goldschmidt Cancer Center
-
Joplin, Missouri, Forente stater, 64804
- Mercy Hospital Joplin
-
Kansas City, Missouri, Forente stater, 64154
- University of Kansas Cancer Center - North
-
Kansas City, Missouri, Forente stater, 64131
- The University of Kansas Cancer Center-South
-
Kansas City, Missouri, Forente stater, 64111
- Saint Luke's Hospital of Kansas City
-
Kansas City, Missouri, Forente stater, 64132
- Research Medical Center
-
Kansas City, Missouri, Forente stater, 64118
- Heartland Hematology and Oncology Associates Incorporated
-
Kansas City, Missouri, Forente stater, 64108
- University Health Truman Medical Center
-
Lee's Summit, Missouri, Forente stater, 64064
- University of Kansas Cancer Center - Lee's Summit
-
Lee's Summit, Missouri, Forente stater, 64086
- Saint Luke's East - Lee's Summit
-
Liberty, Missouri, Forente stater, 64068
- Liberty Hospital
-
Rolla, Missouri, Forente stater, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Rolla, Missouri, Forente stater, 65401
- Phelps Health Delbert Day Cancer Institute
-
Saint Joseph, Missouri, Forente stater, 64506
- Heartland Regional Medical Center
-
Springfield, Missouri, Forente stater, 65804
- Cancer Research for the Ozarks NCORP
-
Springfield, Missouri, Forente stater, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Forente stater, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Forente stater, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, Forente stater, 63109
- Mercy Infusion Center - Chippewa
-
St Louis, Missouri, Forente stater, 63141
- Mercy Hospital Saint Louis
-
-
Montana
-
Billings, Montana, Forente stater, 59101
- Billings Clinic Cancer Center
-
Billings, Montana, Forente stater, 59101
- Saint Vincent Healthcare
-
Billings, Montana, Forente stater, 59102
- Montana Cancer Consortium NCORP
-
Bozeman, Montana, Forente stater, 59715
- Bozeman Health Deaconess Hospital
-
Butte, Montana, Forente stater, 59701
- Saint James Community Hospital and Cancer Treatment Center
-
Great Falls, Montana, Forente stater, 59405
- Benefis Sletten Cancer Institute
-
Helena, Montana, Forente stater, 59601
- Saint Peter's Community Hospital
-
Kalispell, Montana, Forente stater, 59901
- Logan Health Medical Center
-
Missoula, Montana, Forente stater, 59802
- Saint Patrick Hospital - Community Hospital
-
-
Nebraska
-
Lincoln, Nebraska, Forente stater, 68510
- Nebraska Cancer Research Center
-
Omaha, Nebraska, Forente stater, 68114
- Nebraska Methodist Hospital
-
Omaha, Nebraska, Forente stater, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Forente stater, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, Forente stater, 68130
- Alegent Health Lakeside Hospital
-
Omaha, Nebraska, Forente stater, 68106
- Missouri Valley Cancer Consortium
-
-
Nevada
-
Henderson, Nevada, Forente stater, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, Forente stater, 89052
- Cancer and Blood Specialists-Henderson
-
Henderson, Nevada, Forente stater, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, Forente stater, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, Forente stater, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, Forente stater, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, Forente stater, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Forente stater, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, Forente stater, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Forente stater, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Forente stater, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, Forente stater, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Forente stater, 89106
- Cancer and Blood Specialists-Shadow
-
Las Vegas, Nevada, Forente stater, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, Forente stater, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, Forente stater, 89121
- Cancer Therapy and Integrative Medicine
-
Las Vegas, Nevada, Forente stater, 89128
- Cancer and Blood Specialists-Tenaya
-
Las Vegas, Nevada, Forente stater, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, Forente stater, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, Forente stater, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, Forente stater, 89120
- Nevada Cancer Research Foundation NCORP
-
Las Vegas, Nevada, Forente stater, 89128
- Oncology Las Vegas - Tenaya
-
Las Vegas, Nevada, Forente stater, 89183
- OptumCare Cancer Care at Fort Apache
-
-
New Hampshire
-
Lebanon, New Hampshire, Forente stater, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
-
New Jersey
-
Camden, New Jersey, Forente stater, 08103
- Cooper Hospital University Medical Center
-
New Brunswick, New Jersey, Forente stater, 08903
- Rutgers Cancer Institute of New Jersey
-
-
New Mexico
-
Albuquerque, New Mexico, Forente stater, 87106
- University of New Mexico Cancer Center
-
Las Cruces, New Mexico, Forente stater, 88011
- Memorial Medical Center-Las Cruces
-
-
New York
-
Glens Falls, New York, Forente stater, 12801
- Glens Falls Hospital
-
Rochester, New York, Forente stater, 14642
- University of Rochester
-
Syracuse, New York, Forente stater, 13210
- Syracuse Veterans Administration Medical Center
-
The Bronx, New York, Forente stater, 10461
- Montefiore Medical Center-Einstein Campus
-
The Bronx, New York, Forente stater, 10467
- Montefiore Medical Center - Moses Campus
-
-
North Carolina
-
Chapel Hill, North Carolina, Forente stater, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Goldsboro, North Carolina, Forente stater, 27534
- Wayne Memorial Hospital
-
Hendersonville, North Carolina, Forente stater, 28791
- Margaret R Pardee Memorial Hospital
-
Kinston, North Carolina, Forente stater, 28501
- ECU Health Oncology Kinston
-
Statesville, North Carolina, Forente stater, 28677
- Iredell Memorial Hospital
-
-
North Dakota
-
Fargo, North Dakota, Forente stater, 58103
- Essentia Health Cancer Center-South University Clinic
-
-
Ohio
-
Belpre, Ohio, Forente stater, 45714
- Strecker Cancer Center-Belpre
-
Bowling Green, Ohio, Forente stater, 43402
- Toledo Clinic Cancer Centers-Bowling Green
-
Chillicothe, Ohio, Forente stater, 45601
- Adena Regional Medical Center
-
Cincinnati, Ohio, Forente stater, 45242
- Oncology Hematology Care Inc-Blue Ash
-
Cincinnati, Ohio, Forente stater, 45202
- Oncology Hematology Care Inc-Eden Park
-
Cincinnati, Ohio, Forente stater, 45211
- Oncology Hematology Care Inc-Mercy West
-
Cincinnati, Ohio, Forente stater, 45230
- Oncology Hematology Care Inc-Anderson
-
Cincinnati, Ohio, Forente stater, 45236
- Oncology Hematology Care Inc-Kenwood
-
Cleveland, Ohio, Forente stater, 44106
- Case Western Reserve University
-
Columbus, Ohio, Forente stater, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, Forente stater, 43210
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, Forente stater, 43219
- The Mark H Zangmeister Center
-
Columbus, Ohio, Forente stater, 43214
- Columbus Oncology and Hematology Associates Inc
-
Columbus, Ohio, Forente stater, 43228
- Doctors Hospital
-
Columbus, Ohio, Forente stater, 43215
- Grant Medical Center
-
Columbus, Ohio, Forente stater, 43222
- Mount Carmel Health Center West
-
Columbus, Ohio, Forente stater, 43215
- Columbus NCI Community Oncology Research Program
-
Dayton, Ohio, Forente stater, 45406
- Good Samaritan Hospital - Dayton
-
Dayton, Ohio, Forente stater, 45409
- Miami Valley Hospital
-
Dayton, Ohio, Forente stater, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, Forente stater, 45459
- Dayton NCI Community Oncology Research Program
-
Delaware, Ohio, Forente stater, 43015
- Delaware Health Center-Grady Cancer Center
-
Delaware, Ohio, Forente stater, 43015
- Delaware Radiation Oncology
-
Delaware, Ohio, Forente stater, 43015
- Grady Memorial Hospital
-
Fairfield, Ohio, Forente stater, 45014
- Oncology Hematology Care Inc-Healthplex
-
Findlay, Ohio, Forente stater, 45840
- Blanchard Valley Hospital
-
Franklin, Ohio, Forente stater, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Greenville, Ohio, Forente stater, 45331
- Wayne Hospital
-
Kettering, Ohio, Forente stater, 45429
- Kettering Medical Center
-
Lancaster, Ohio, Forente stater, 43130
- Fairfield Medical Center
-
Lancaster, Ohio, Forente stater, 43130
- Lancaster Radiation Oncology
-
Lima, Ohio, Forente stater, 45804
- Lima Memorial Hospital
-
Marietta, Ohio, Forente stater, 45750
- Marietta Memorial Hospital
-
Maumee, Ohio, Forente stater, 43537
- Toledo Clinic Cancer Centers-Maumee
-
Maumee, Ohio, Forente stater, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
-
Mount Vernon, Ohio, Forente stater, 43050
- Knox Community Hospital
-
Newark, Ohio, Forente stater, 43055
- Licking Memorial Hospital
-
Newark, Ohio, Forente stater, 43055
- Newark Radiation Oncology
-
Oregon, Ohio, Forente stater, 43616
- Saint Charles Hospital
-
Oregon, Ohio, Forente stater, 43616
- Toledo Clinic Cancer Centers-Oregon
-
Portsmouth, Ohio, Forente stater, 45662
- Southern Ohio Medical Center
-
Springfield, Ohio, Forente stater, 45504
- Springfield Regional Medical Center
-
Sylvania, Ohio, Forente stater, 43560
- ProMedica Flower Hospital
-
Tiffin, Ohio, Forente stater, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Forente stater, 43623
- Mercy Health - Saint Anne Hospital
-
Toledo, Ohio, Forente stater, 43623
- Toledo Clinic Cancer Centers-Toledo
-
Toledo, Ohio, Forente stater, 43614
- University of Toledo
-
Toledo, Ohio, Forente stater, 43617
- Toledo Community Hospital Oncology Program CCOP
-
Toledo, Ohio, Forente stater, 43608
- Mercy Health - Saint Vincent Hospital
-
Troy, Ohio, Forente stater, 45373
- Upper Valley Medical Center
-
Wauseon, Ohio, Forente stater, 43567
- Fulton County Health Center
-
Westerville, Ohio, Forente stater, 43081
- Saint Ann's Hospital
-
Zanesville, Ohio, Forente stater, 43701
- Genesis Healthcare System Cancer Care Center
-
-
Oklahoma
-
Lawton, Oklahoma, Forente stater, 73505
- Cancer Centers of Southwest Oklahoma Research
-
Oklahoma City, Oklahoma, Forente stater, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, Forente stater, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
-
-
Oregon
-
Clackamas, Oregon, Forente stater, 97015
- Clackamas Radiation Oncology Center
-
Milwaukie, Oregon, Forente stater, 97222
- Providence Milwaukie Hospital
-
Newberg, Oregon, Forente stater, 97132
- Providence Newberg Medical Center
-
Oregon City, Oregon, Forente stater, 97045
- Providence Willamette Falls Medical Center
-
Portland, Oregon, Forente stater, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Forente stater, 97225
- Providence Saint Vincent Medical Center
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, Forente stater, 18015
- Saint Luke's University Hospital-Bethlehem Campus
-
Danville, Pennsylvania, Forente stater, 17822
- Geisinger Medical Center
-
Hazleton, Pennsylvania, Forente stater, 18201
- Geisinger Medical Center-Cancer Center Hazleton
-
Sayre, Pennsylvania, Forente stater, 18840
- Guthrie Medical Group PC-Robert Packer Hospital
-
State College, Pennsylvania, Forente stater, 16801
- Geisinger Medical Group
-
Wilkes-Barre, Pennsylvania, Forente stater, 18711
- Geisinger Wyoming Valley/Henry Cancer Center
-
Williamsport, Pennsylvania, Forente stater, 17701
- UPMC Susquehanna
-
-
South Carolina
-
Boiling Springs, South Carolina, Forente stater, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Florence, South Carolina, Forente stater, 29506
- McLeod Regional Medical Center
-
Greenville, South Carolina, Forente stater, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, Forente stater, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, Forente stater, 29605
- Prisma Health Cancer Institute - Butternut
-
Greenville, South Carolina, Forente stater, 29605
- Prisma Health Greenville Memorial Hospital
-
Greer, South Carolina, Forente stater, 29650
- Prisma Health Cancer Institute - Greer
-
Seneca, South Carolina, Forente stater, 29672
- Prisma Health Cancer Institute - Seneca
-
-
South Dakota
-
Rapid City, South Dakota, Forente stater, 57701
- Rapid City Regional Hospital
-
-
Texas
-
Dallas, Texas, Forente stater, 75246
- Baylor University Medical Center
-
Houston, Texas, Forente stater, 77030
- Houston Methodist Hospital
-
San Antonio, Texas, Forente stater, 78229
- University of Texas Health Science Center at San Antonio
-
-
Utah
-
American Fork, Utah, Forente stater, 84003
- American Fork Hospital / Huntsman Intermountain Cancer Center
-
Cedar City, Utah, Forente stater, 84720
- Sandra L Maxwell Cancer Center
-
Logan, Utah, Forente stater, 84321
- Logan Regional Hospital
-
Murray, Utah, Forente stater, 84107
- Intermountain Medical Center
-
Ogden, Utah, Forente stater, 84403
- McKay-Dee Hospital Center
-
Provo, Utah, Forente stater, 84604
- Utah Valley Regional Medical Center
-
Salt Lake City, Utah, Forente stater, 84106
- Utah Cancer Specialists-Salt Lake City
-
Salt Lake City, Utah, Forente stater, 84143
- LDS Hospital
-
St. George, Utah, Forente stater, 84770
- Saint George Regional Medical Center
-
-
Vermont
-
Bennington, Vermont, Forente stater, 05201
- Southwestern Vermont Medical Center
-
-
Virginia
-
Fredericksburg, Virginia, Forente stater, 22401
- Fredericksburg Oncology Inc
-
-
Washington
-
Vancouver, Washington, Forente stater, 98664
- PeaceHealth Southwest Medical Center
-
Vancouver, Washington, Forente stater, 98684
- Compass Oncology Vancouver
-
-
West Virginia
-
Huntington, West Virginia, Forente stater, 25701
- Edwards Comprehensive Cancer Center
-
-
Wisconsin
-
Chippewa Falls, Wisconsin, Forente stater, 54729
- Marshfield Clinic-Chippewa Center
-
Eau Claire, Wisconsin, Forente stater, 54701
- HSHS Sacred Heart Hospital
-
Eau Claire, Wisconsin, Forente stater, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Green Bay, Wisconsin, Forente stater, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, Forente stater, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Green Bay, Wisconsin, Forente stater, 54301-3526
- Green Bay Oncology at Saint Vincent Hospital
-
Madison, Wisconsin, Forente stater, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Manitowoc, Wisconsin, Forente stater, 54221
- Holy Family Memorial Hospital
-
Marshfield, Wisconsin, Forente stater, 54449
- Marshfield Medical Center-Marshfield
-
Marshfield, Wisconsin, Forente stater, 54449
- Marshfield Medical Center
-
Milwaukee, Wisconsin, Forente stater, 53226
- Medical College of Wisconsin
-
Minocqua, Wisconsin, Forente stater, 54548
- Marshfield Medical Center - Minocqua
-
New Richmond, Wisconsin, Forente stater, 54017
- Cancer Center of Western Wisconsin
-
Oconto Falls, Wisconsin, Forente stater, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Rhinelander, Wisconsin, Forente stater, 54501
- Saint Mary's Hospital
-
Rhinelander, Wisconsin, Forente stater, 54501
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
-
Rice Lake, Wisconsin, Forente stater, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, Forente stater, 53081
- HSHS Saint Nicholas Hospital
-
Stevens Point, Wisconsin, Forente stater, 54481
- Aspirus Cancer Care - Stevens Point
-
Wausau, Wisconsin, Forente stater, 54401
- Marshfield Clinic-Wausau Center
-
Weston, Wisconsin, Forente stater, 54476
- Marshfield Medical Center - Weston
-
Wisconsin Rapids, Wisconsin, Forente stater, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
Wyoming
-
Casper, Wyoming, Forente stater, 82609
- Rocky Mountain Oncology
-
Sheridan, Wyoming, Forente stater, 82801
- Welch Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
Andre navn:
Undergo blood sample collection
Andre navn:
Undergo CT
Andre navn:
Undergo MRI
Andre navn:
Given PO
Andre navn:
Undergo ECHO
Andre navn:
Undergo MUGA
Andre navn:
Undergo chest x-ray
Andre navn:
|
|
Placebo komparator: 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
Andre navn:
Undergo blood sample collection
Andre navn:
Undergo CT
Andre navn:
Undergo MRI
Andre navn:
Given PO Undergo ECHO
Andre navn:
Undergo MUGA
Andre navn:
Undergo chest x-ray
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free Survival (PFS)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Best Response
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to Second Progression for Patients Who Crossover From Placebo to Active Therapy
Tidsramme: 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
Tidsramme: At 6 months
|
Kaplan-Meier methods will be used including calculations of 95% confidence intervals. |
At 6 months
|
|
Biochemical Response
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Emily K Bergsland, Alliance for Clinical Trials in Oncology
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Antatt)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer etter histologisk type
- Nevroektodermale svulster
- Neoplasmer, kjønnsceller og embryonale
- Neoplasmer, nervevev
- Nevroendokrine svulster
- Undersøkelsesteknikker
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Fysiske fenomener
- Utstyr og forsyninger
- Kjemisteknikker, analytisk
- Spektrumanalyse
- Elektromagnetiske fenomener
- Magnetiske fenomener
- Elektromagnetisk stråling
- Stråling
- Stråling, ioniserende
- Prøvehåndtering
- Magnetisk resonansspektroskopi
- Røntgenbilder
- Pazopanib
- Fantomer, avbildning
Andre studie-ID-numre
- NCI-2013-00831
- U10CA180821 (U.S. NIH-stipend/kontrakt)
- U10CA180830 (U.S. NIH-stipend/kontrakt)
- U10CA031946 (U.S. NIH-stipend/kontrakt)
- NCI-2013-00831 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- ALLIANCE A021202
- CALGB-A021202
- A021202 (Annen identifikator: CTEP)
- A021202 (Annen identifikator: Alliance for Clinical Trials in Oncology)
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