Vapreotide in Treating Patients Undergoing Elective Pancreatic Resection
NCT ID: NCT00014651
Last Updated: 2010-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
INTERVENTIONAL
2001-03-31
2002-04-30
Brief Summary
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PURPOSE: This randomized phase III trial is studying vapreotide to see how well it works compared to a placebo in preventing complications in patients undergoing surgery for pancreatic cancer.
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Detailed Description
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OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients undergo surgical resection on day 1 and receive vapreotide subcutaneously twice daily on days 1-7. Arm II: Patients undergo surgical resection and receive a placebo as in arm I. Patients are followed at days 28 and 45.
PROJECTED ACCRUAL: A total of 580 patients (290 per arm) will be accrued for this study.
Conditions
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Study Design
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SUPPORTIVE_CARE
Interventions
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vapreotide
conventional surgery
Eligibility Criteria
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Exclusion Criteria
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No neoadjuvant or postoperative adjuvant chemotherapy from 2 weeks before to 2 weeks after surgery Endocrine therapy: At least 4 weeks since prior somatostatin or somatostatin analogue No other concurrent somatostatin or somatostatin analogues Radiotherapy: No neoadjuvant or postoperative adjuvant radiotherapy from 2 weeks before to 2 weeks after surgery Surgery: See Disease Characteristics Other: No concurrent pancreatic enzyme inhibitors (e.g., antiproteases) No concurrent immunosuppressive agents
18 Years
90 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Mayo Clinic
Principal Investigators
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Michael G. Sarr, MD, FACS
Role: STUDY_CHAIR
Mayo Clinic
Locations
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University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
Moffett Cancer Center (South)
Tampa, Florida, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Taubman Health Care Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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MAYO-IRB-B-234-00
Identifier Type: -
Identifier Source: secondary_id
MAYO-FDR001827
Identifier Type: -
Identifier Source: secondary_id
NCI-G01-1938
Identifier Type: -
Identifier Source: secondary_id
CDR0000068584
Identifier Type: -
Identifier Source: org_study_id
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