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Vapreotide in Treating Patients Undergoing Elective Pancreatic Resection
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Mayo Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00014651
  Purpose

RATIONALE: Drugs such as vapreotide may prevent complications following pancreatic resection. It is not yet known if vapreotide is more effective than no further therapy in preventing side effects of pancreatic resection.

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.


Condition Intervention Phase
Cancer-Related Problem/Condition
Pancreatic Cancer
Drug: vapreotide
Procedure: conventional surgery
Phase III

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Pancrelipase Ultrase Vapreotide
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care
Official Title: Vapreotide in Pancreas Surgery: A Double-Blind, Placebo-Controlled, Randomized Study of Vapreotide to Prevent Post-Surgical Complications in Patients Undergoing Elective Pancreatic Resection Grant Application Title: Vapreotide to Prevent Complications of Pancreatic Resection

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

Study Start Date: March 2001
Detailed Description:

OBJECTIVES: I. Compare the efficacy of vapreotide versus placebo in reducing postoperative pancreatic complications in patients undergoing elective pancreatic resection. II. Compare the postoperative complications occurring within 45 days after surgery unrelated to the pancreas, days of hospitalization and survival at 45 days after surgery, number of rehospitalizations, and number of postoperative blood units or packed red blood cells administered in patients treated with these regimens.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Planned elective pancreatic resection due to presumed pancreatic tumor (either proximal or distal pancreatic lesion) or presumed neoplasm of the ampullary or periampullary region Require peri-anastomotic drain(s) near the pancreaticoenterostomy or near the pancreatic stump closure The following are excluded: Emergency surgery of the pancreas (acute pancreatitis, pancreatic trauma) Known chronic pancreatitis (pancreatic cancer with duct obstructive chronic pancreatitis allowed) Need for total pancreatectomy Need for pancreatic transplantation Need for elective pancreatic-cyst anastomosis Need for pancreatic duct drainage operation without resection (pancreatic stents allowed if performed with partial pancreatic resection) Enucleation of a pancreatic neoplasm

PATIENT CHARACTERISTICS: Age: 18 to 90 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2 times upper limit of normal Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014651

Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Florida
Moffett Cancer Center (South)
Tampa, Florida, United States, 33601
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Taubman Health Care Center
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
University of Texas Medical Branch
Galveston, Texas, United States, 77555-1329
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Michael G. Sarr, MD, FACS Mayo Clinic
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000068584, MAYO-IRB-B-234-00, MAYO-FDR001827, NCI-G01-1938
Study First Received: April 10, 2001
Last Updated: October 18, 2008
ClinicalTrials.gov Identifier: NCT00014651  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
perioperative/postoperative complications
stage I pancreatic cancer

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Postoperative Complications
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Pancrelipase
Vapreotide
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009