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”

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.

Study Type: Interventional

Study Design: Supportive Care

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.

Intervention(s) in this Clinical Trial

• Drug: vapreotide
• Procedure: conventional surgery

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mayo Clinic

Overall Clinical Trial Officials and Contacts

Michael G. Sarr, MD, FACS Study Chair Mayo Clinic  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00014651

Study ID Number: CDR0000068584

ClinicalTrials.gov Identifier: NCT00014651

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database