Trial record 1 of 1 for:    CALGB 80701
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Everolimus and Octreotide With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed By Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01229943
First received: October 27, 2010
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

This randomized phase II trial studies how well everolimus and octreotide with or without bevacizumab works in treating patients with locally advanced or metastatic pancreatic neuroendocrine tumors that cannot be removed by surgery. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Octreotide may interfere with and slow the growth of tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab and everolimus also may stop the growth of pancreatic neuroendocrine tumors by blocking blood flow to the tumor. It is not yet known whether giving everolimus and octreotide together is more effective with or without bevacizumab in treating pancreatic neuroendocrine tumors.


Condition Intervention Phase
Gastrinoma
Glucagonoma
Insulinoma
Pancreatic Alpha Cell Adenoma
Pancreatic Alpha Cell Carcinoma
Pancreatic Beta Islet Cell Adenoma
Pancreatic Beta Islet Cell Carcinoma
Pancreatic Delta Cell Adenoma
Pancreatic Delta Cell Carcinoma
Pancreatic G-cell Adenoma
Pancreatic G-cell Carcinoma
Pancreatic Polypeptide Tumor
Recurrent Islet Cell Carcinoma
Recurrent Pancreatic Cancer
Somatostatinoma
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Drug: octreotide acetate
Drug: everolimus
Biological: bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Everolimus Alone Versus Everolimus Plus Bevacizumab in Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: From study entry to the date of documented progression or death from any cause, up to 3 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier will be used to estimate the PFS curves within each treatment arm.


Secondary Outcome Measures:
  • Response rate measured by RECIST [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Incidence of adverse events graded according to CTCAE version 4.0 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: From registration to time of death, assessed up to 3 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier will be used to estimate the OS curves within each treatment arm.


Estimated Enrollment: 138
Study Start Date: October 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (octreotide acetate and everolimus)
Patients receive everolimus PO QD on days 1-28 and octreotide LAR IM on day 1.
Drug: octreotide acetate
Given IM
Other Names:
  • Longastatin
  • Longastatina
  • Samilstin
  • SMS 201-995
Drug: everolimus
Given PO
Other Names:
  • 42-O-(2-hydroxy)ethyl rapamycin
  • Afinitor
  • RAD001
Experimental: Arm II (octreotide acetate, everolimus, and bevacizumab)
Patients receive everolimus and octreotide LAR as in arm I. Patients also receive bevacizumab IV on days 1 and 15.
Drug: octreotide acetate
Given IM
Other Names:
  • Longastatin
  • Longastatina
  • Samilstin
  • SMS 201-995
Drug: everolimus
Given PO
Other Names:
  • 42-O-(2-hydroxy)ethyl rapamycin
  • Afinitor
  • RAD001
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF

Detailed Description:

PRIMARY OBJECTIVES:

l. To assess the progression-free survival (PFS) rate of patients with locally advanced or metastatic pancreatic neuroendocrine tumors treated with everolimus alone or everolimus plus bevacizumab.

SECONDARY OBJECTIVES:

I. To compare PFS among treatment arms shown to be efficacious. II. To estimate the overall tumor response rate in patients with metastatic pancreatic neuroendocrine tumors treated with one of two novel regimens.

III. To estimate the overall biochemical response rate (as measured by plasma chromogranin A levels) in patients with metastatic pancreatic neuroendocrine tumors treated with these regimens.

IV. To assess the toxicity of each regimen in patients with metastatic pancreatic neuroendocrine tumors.

V. To assess the overall survival of patients with pancreatic neuroendocrine tumors treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment with cytotoxic chemotherapy (no vs yes), prior use of octreotide (no vs yes), and prior therapy with sunitinib (no vs yes). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive everolimus orally (PO) once daily (QD) on days 1-28 and octreotide LAR intramuscularly (IM) on day 1.

ARM II: Patients receive everolimus and octreotide LAR as in arm I. Patients also receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-6 months for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologic documentation of well-differentiated or moderately differentiated neuroendocrine tumor from either a primary or metastatic site

    • If different histologic classification schemes are used, equivalent histologic classifications (for example "grade 1", "low-grade", or "intermediate-grade") are allowed
    • Patients with poorly differentiated neuroendocrine carcinoma or small cell carcinoma are excluded
    • Documentation from a metastatic disease site is sufficient if there is clinical evidence of a pancreatic primary site
  • Locally unresectable or metastatic disease
  • Patients must have either histologic documentation of a pancreatic primary site, or clinical evidence of a pancreatic neuroendocrine primary tumor as determined by the treating physician

    • Patients with neuroendocrine tumors (e.g., gastrinoma, VIPoma) in whom a pancreatic or peripancreatic primary site is strongly suspected are also eligible
  • Patients must have evidence of disease (measurable or non-measurable) with evidence of progression within the past 12 months
  • Measurable Disease:

Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan

  • Non-measurable Disease:

All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions; lesions that are considered non-measurable include the following:

  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Inflammatory breast disease
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions

    • No prior treatment with bevacizumab, everolimus, or other mammalian target of rapamycin (mTOR) inhibitors
    • Other prior treatments, including but not limited to prior cytotoxic chemotherapy, alpha interferon, tyrosine kinase inhibitors, external beam radiation therapy, and radiopeptide therapy are allowed
  • There is no limit on the number of prior treatment regimens
  • Any prior treatment (with the exception of octreotide) must be completed at least 4 weeks prior to initiation of treatment

    • Prior treatment with embolization or ablative therapies is allowed if measurable disease remains outside of the treated area
  • There is no limit on the prior number of procedures

    • Treatment with somatostatin analogs is a requirement of the study
  • Patients receiving octreotide at the time of study entry may continue at the same dose level for the duration of the study
  • Patients not receiving octreotide will initiate treatment according to study guidelines
  • Prior progression on somatostatin analogs or a negative octreotide scan does not exclude patient participation in this study

    • Patients should have completed any major surgery >= 4 weeks from start of treatment
  • Patients must have completed any minor surgery >= 2 weeks prior to start of treatment
  • Patients must have fully recovered from the procedure
  • Insertion of a vascular access device is not considered major or minor surgery

    • Patients should not receive immunization with attenuated live vaccines within one week prior to registration or during protocol therapy
    • No concurrent condition resulting in immune compromise, including chronic treatment with corticosteroids or other immuno suppressive agents
    • No active or severe liver disease (e.g., acute or chronic hepatitis, cirrhosis); no positive anti-hepatitis B (HBV); HBV seropositive patients (hepatitis B surface antigen [HBsAg] positive) are eligible if they are closely monitored for evidence of active HBV infection by HBV deoxyribonucleic acid (DNA) testing, and they agree to receive suppressive therapy with lamivudine or other HBV-suppressive therapy until at least 4 weeks after the last dose of everolimus; patients who are hepatitis C antibody positive are eligible provided that hepatitis C viral load (hepatitis C ribonucleic acid [RNA]) is undetectable
    • No clinical evidence of brain metastases or carcinomatous meningitis
    • No history of gastrointestinal (GI) perforation within 12 months prior to registration
    • No history of clinically significant bleeding episodes
    • Patients on therapeutic anticoagulation are eligible for the study provided that they are on a stable dose of anticoagulants
    • No uncontrolled diabetes mellitus
    • Patients with a history of severely impaired lung function as defined as spirometry and diffusion lung capacity for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or oxygen (O2) saturation that is 88% or less at rest on room air are excluded
    • Patients with fasting serum cholesterol >= 300 mg/dL OR >= 7.75 mmol/L AND fasting triglycerides >= 2.5 X upper limit of normal (ULN) should initiate lipid-lowering medications with the goal of achieving levels below these thresholds
    • No history of intolerance or allergies to octreotide
    • Patients with a history of hypertension must be adequately controlled (baseline blood pressure [BP] < 150/90 mm Hg) on antihypertensives
    • No current congestive heart failure (New York Heart Association Class II, III, or IV)
    • No symptomatic arterial peripheral vascular disease
    • No history of aortic aneurysm, aortic dissection, angina, myocardial infarction, stroke, or other arterial thrombotic events within 6 months of registration
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    • Women must not be pregnant or lactating; both men and women of childbearing potential must be advised of the importance of using effective birth control measures during the course of the study
    • Granulocytes >= 1,500/uL
    • Platelets >= 100,000/uL
    • Creatinine =< 1.5 x upper limit of normal (ULN)
    • Bilirubin =< 1.5 x ULN
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN) (=< 5 x ULN if liver metastases present)
    • Urine protein =< 1+ OR urine creatinine ratio < 1 by urinalysis (if UPC ratio is > 1 on urinalysis, then 24-hour urine collection for protein must be obtained and level must be < 1,000 mg for patient enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229943

  Hide Study Locations
Locations
United States, Alabama
Providence Hospital
Mobile, Alabama, United States, 36608
United States, California
Kaiser Anaheim Medical Center
Anaheim, California, United States, 92807
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States, 94531
Kaiser Permanente Medical Group - Baldwin Park
Baldwin Park, California, United States, 91706
Kaiser Foundation Hospital
Bellflower, California, United States, 90706
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
Mills - Peninsula Hospitals
Burlingame, California, United States, 94010
Kaiser Permanente Hospital
Fontana, California, United States, 92335
Kaiser Permanente, Fremont
Fremont, California, United States, 94538
Kaiser Permanente
Fresno, California, United States, 93720
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
Kaiser Permanente - Harbor City
Harbor City, California, United States, 90710
Kaiser Permanente, Hayward
Hayward, California, United States, 94545
Southern California Permanente Medical Group
Irvine, California, United States, 92618
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Kaiser Permanente-West Los Angeles
Los Angeles, California, United States, 90034
Kaiser Permanente
Los Angeles, California, United States, 90027
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Kaiser Permanente - Panorama City
Panorama City, California, United States, 91402
Kaiser Permanente-Redwood City
Redwood City, California, United States, 94063
Kaiser Permanente-Richmond
Richmond, California, United States, 94801
Kaiser Permanente Medical Center
Riverside, California, United States, 92505
Kaiser Permanente-Roseville
Roseville, California, United States, 95661
Kaiser Permanente-South Sacramento
Sacramento, California, United States, 95823
Kaiser Permanente - Sacramento
Sacramento, California, United States, 95825
Kaiser Permanente at San Diego
San Diego, California, United States, 92120
Kaiser Permanente-Mission
San Diego, California, United States, 92108
Kaiser Permanente
San Diego, California, United States, 92120
California Pacific Medical Center
San Francisco, California, United States, 94118
Kaiser Permanente-San Francisco
San Francisco, California, United States, 94115
UCSF-Mount Zion
San Francisco, California, United States, 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States, 95119
Kaiser Permanente Health Care
San Marcos, California, United States, 92069
Kaiser Permanente-San Rafael
San Rafael, California, United States, 94903
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States, 95403
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
Kaiser Permanente-South San Francisco
South San Francisco, California, United States, 94080
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
Kaiser Permanente-Stockton
Stockton, California, United States, 95210
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, United States, 95688
Kaiser Permanente-Vallejo
Vallejo, California, United States, 94589
Sutter Solano Medical Center
Vallejo, California, United States, 94589
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States, 94596
Kaiser Permanente
Woodland Hills, California, United States, 91367
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Saint Anthony Central Hospital
Denver, Colorado, United States, 80204
Rose Medical Center
Denver, Colorado, United States, 80220
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Swedish Medical Center
Englewood, Colorado, United States, 80110
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Parker Adventist Hospital
Parker, Colorado, United States, 80138
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University
Washington, District of Columbia, United States, 20057
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
Florida Hospital
Orlando, Florida, United States, 32803
United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Hawaii
Kapiolani Medical Center at Pali Momi
Aiea, Hawaii, United States, 96701
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States, 96819
Hawaii Medical Center East
Honolulu, Hawaii, United States, 96817
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, United States, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
OnCare Hawaii-Liliha
Honolulu, Hawaii, United States, 96817-3169
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States, 96813
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
University of Hawaii
Honolulu, Hawaii, United States, 96813
Castle Medical Center
Kailua, Hawaii, United States, 96734
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
Pacific Cancer Institute of Maui
Wailuku, Hawaii, United States, 96793
Maui Memorial Medical Center
Wailuku, Hawaii, United States, 96793
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
Sherman Hospital
Elgin, Illinois, United States, 60123
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States, 60035
Presence Saint Mary's Hospital
Kankakee, Illinois, United States, 60901
Adventist La Grange Memorial Hospital
La Grange, Illinois, United States, 60525
North Shore Hematology Oncology
Libertyville, Illinois, United States, 60048
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, United States, 61265
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, United States, 61265
Spector, David MD (UIA Investigator)
Moline, Illinois, United States, 61265
Trinity Medical Center
Moline, Illinois, United States, 61265
Illinois Cancer Specialists-Niles
Niles, Illinois, United States, 60714
Swedish American Hospital
Rockford, Illinois, United States, 61104
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States, 60076
United States, Indiana
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Wishard Hospital
Indianapolis, Indiana, United States, 46202
Reid Hospital and Health Care Services
Richmond, Indiana, United States, 47374
United States, Iowa
McFarland Clinic
Ames, Iowa, United States, 50010
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, United States, 52722
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Ottumwa Regional Health Center
Ottumwa, Iowa, United States, 52501
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States, 50266
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Stormont-Vail Regional Health Center
Topeka, Kansas, United States, 66604
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita CCOP
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Ochsner Clinic Foundation-Baton Rouge
Baton Rouge, Louisiana, United States, 70809
Ochsner North Shore Medical Center
Covington, Louisiana, United States, 70433
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States, 70115
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Ochsner Clinic CCOP
New Orleans, Louisiana, United States, 70121
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
Hickman Cancer Center
Adrian, Michigan, United States, 49221
Bixby Medical Center
Adrian, Michigan, United States, 49221
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49431
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Allegiance Health
Jackson, Michigan, United States, 49201
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy Memorial Hospital
Monroe, Michigan, United States, 48162
Mercy Health Partners-Mercy Campus
Muskegon, Michigan, United States, 49444
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Munson Medical Center
Traverse City, Michigan, United States, 49684
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Essentia Health Duluth Clinic CCOP
Duluth, Minnesota, United States, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
University of Missouri - Ellis Fischel
Columbia, Missouri, United States, 65203
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Radiation Oncology Clinic
Liberty, Missouri, United States, 64068
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States, 64507
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110
Comprehensive Cancer Care PC
Saint Louis, Missouri, United States, 63141
United States, Montana
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Billings Clinic
Billings, Montana, United States, 59107-7000
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Big Sky Oncology
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
United States, Nebraska
Saint Francis Medical Center
Grand Island, Nebraska, United States, 68803
Great Plains Regional Medical Center
North Platte, Nebraska, United States, 69103
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Norris Cotton Cancer Center-Manchester
Manchester, New Hampshire, United States, 03102
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States, 07103
United States, New York
New York Oncology Hematology PC -Albany Medical Center
Albany, New York, United States, 12208
New York Oncology Hematology PC - Albany
Albany, New York, United States, 12206
New York Oncology Hematology PC - Amsterdam
Amsterdam, New York, United States, 12010
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Hematology Oncology Associates of Central New York PC
East Syracuse, New York, United States, 13057
Glens Falls Hospital
Glens Falls, New York, United States, 12801
New York Oncology Hematology PC-Hudson
Hudson, New York, United States, 12534
New York Oncology Hematology PC - Latham
Latham, New York, United States, 12110
Orange Regional Medical Center
Middletown, New York, United States, 10940
New York Oncology Hematology PC - Rexford
Rexford, New York, United States, 12148
New York Oncology Hematology PC - Troy
Troy, New York, United States, 12180
United States, North Carolina
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
Saint Alexius Medical Center
Bismarck, North Dakota, United States, 58501
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
United States, Ohio
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States, 43402
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
North Coast Cancer Care-Clyde
Clyde, Ohio, United States, 43410
Columbus CCOP
Columbus, Ohio, United States, 43215
Doctors Hospital
Columbus, Ohio, United States, 43228
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Grant Medical Center
Columbus, Ohio, United States, 43215
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Dayton CCOP
Dayton, Ohio, United States, 45420
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Grandview Hospital
Dayton, Ohio, United States, 45405
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Community Health Partners Regional Medical Center
Elyria, Ohio, United States, 44035
Hematology Oncology Center Incorporated
Elyria, Ohio, United States, 44035
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Kettering Medical Center
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States, 43537
Saint Luke's Hospital
Maumee, Ohio, United States, 43537
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States, 43537-1839
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Fisher-Titus Medical Center
Norwalk, Ohio, United States, 44857
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States, 43616
Saint Charles Hospital
Oregon, Ohio, United States, 43616
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
North Coast Cancer Care
Sandusky, Ohio, United States, 44870
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States, 43617
University of Toledo
Toledo, Ohio, United States, 43614
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
Mercy Cancer Center at Saint Anne Mercy Hospital
Toledo, Ohio, United States, 43623
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States, 43623
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis HealthCare System
Zanesville, Ohio, United States, 43701
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Columbia River Oncology Program
Portland, Oregon, United States, 97225
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Adventist Medical Center
Portland, Oregon, United States, 97216
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Butler Memorial Hospital
Butler, Pennsylvania, United States, 16001
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Geisinger Medical Center-Cancer Center Hazelton
Hazleton, Pennsylvania, United States, 18201
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, United States, 19464
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Reading Hospital and Medical Center
West Reading, Pennsylvania, United States, 19612
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Carolina
Roper Hospital
Charleston, South Carolina, United States, 29401
Greenville CCOP
Greenville, South Carolina, United States, 29615
Cancer Centers of the Carolinas - Faris
Greenville, South Carolina, United States, 29605
Cancer Centers of the Carolinas - Grove Commons
Greenville, South Carolina, United States, 29605
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Self Regional Healthcare
Greenwood, South Carolina, United States, 29646
Cancer Centers of the Carolinas-Greer Medical Oncology
Greer, South Carolina, United States, 29650
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, United States, 29672
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
University of Tennessee - Knoxville
Knoxville, Tennessee, United States, 37920
United States, Texas
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, United States, 79106
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Zale Lipshy University Hospital
Dallas, Texas, United States, 75235
United States, Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States, 22401
United States, Washington
Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Harrison Bremerton Hematology and Oncology
Bremerton, Washington, United States, 98310
Highline Medical Center-Main Campus
Burien, Washington, United States, 98166
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Columbia Basin Hematology and Oncology PLLC
Kennewick, Washington, United States, 99336
Skagit Valley Hospital
Mount Vernon, Washington, United States, 98274
Harrison Poulsbo Hematology and Oncology
Poulsbo, Washington, United States, 98370
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Harborview Medical Center
Seattle, Washington, United States, 98104
The Polyclinic
Seattle, Washington, United States, 98122
University of Washington Medical Center
Seattle, Washington, United States, 98195
Group Health Cooperative
Seattle, Washington, United States, 98112
United General Hospital
Sedro-Woolley, Washington, United States, 98284
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Evergreen Hematology and Oncology PS
Spokane, Washington, United States, 99218
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
Northwest Cancer Specialists
Vancouver, Washington, United States, 98684
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, United States, 54601
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Saint Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Canada, British Columbia
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, New Brunswick
The Vitalite Health Network - Dr Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Nova Scotia
QEII Health Sciences Centre - Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V8
Canada, Ontario
Ottawa Health Research Institute-General Division
Ottawa, Ontario, Canada, K1H 1C4
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
Investigators
Principal Investigator: Matthew Kulke Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01229943     History of Changes
Other Study ID Numbers: NCI-2011-02609, NCI-2011-02609, CDR0000687459, CALGB-80701, CALGB 80701, CALGB-80701, U10CA031946
Study First Received: October 27, 2010
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenoma
Carcinoma
Gastrinoma
Zollinger-Ellison Syndrome
Glucagonoma
Insulinoma
Adenoma, Islet Cell
Pancreatic Neoplasms
Somatostatinoma
Neuroendocrine Tumors
Carcinoma, Islet Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paraneoplastic Endocrine Syndromes
Paraneoplastic Syndromes
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Intestinal Diseases
Peptic Ulcer
Stomach Diseases
Carcinoma, Neuroendocrine
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on April 17, 2014