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Vapreotide in Treating Patients Undergoing Elective Pancreatic Resection

Primary Purpose

Pancreatic Cancer, Perioperative/Postoperative Complications

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
vapreotide
conventional surgery
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreatic Cancer focused on measuring perioperative/postoperative complications, stage I pancreatic cancer

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama Comprehensive Cancer Center
  • Moffett Cancer Center (South)
  • Rush-Presbyterian-St. Luke's Medical Center
  • University of Chicago Cancer Research Center
  • Loyola University Medical Center
  • Johns Hopkins Oncology Center
  • Massachusetts General Hospital Cancer Center
  • Brigham and Women's Hospital
  • Taubman Health Care Center
  • Barbara Ann Karmanos Cancer Institute
  • Mayo Clinic Cancer Center
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
  • Duke Comprehensive Cancer Center
  • University of Pennsylvania Cancer Center
  • University of Texas Medical Branch
  • University of Texas - MD Anderson Cancer Center
  • Virginia Mason Medical Center
  • Medical College of Wisconsin

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 10, 2001
Last Updated
August 6, 2010
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00014651
Brief Title
Vapreotide in Treating Patients Undergoing Elective Pancreatic Resection
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Terminated
Why Stopped
Teminated by the DSMB because there are no differences between the control group and the Vapreotide group
Study Start Date
March 2001 (undefined)
Primary Completion Date
March 2001 (Actual)
Study Completion Date
April 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Perioperative/Postoperative Complications
Keywords
perioperative/postoperative complications, stage I pancreatic cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
vapreotide
Intervention Type
Procedure
Intervention Name(s)
conventional surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael G. Sarr, MD, FACS
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Moffett Cancer Center (South)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33601
Country
United States
Facility Name
Rush-Presbyterian-St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Johns Hopkins Oncology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Taubman Health Care Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-1329
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98111
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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Vapreotide in Treating Patients Undergoing Elective Pancreatic Resection

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