Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Vapreotide in Treating Patients Undergoing Elective Pancreatic Resection

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Closed 18 to 90 NCI MAYO-IRB-B-234-00 MAYO-FDR001827, NCI-G01-1938, NCT00014651

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.

Entry 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 

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

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

Expected Enrollment

A total of 580 patients (290 per arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

Michael Sarr, MD, FACS, Protocol chair		Ph: 507-255-5713

Registry Information
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
Trial Start Date		2001-03-07
Registered in ClinicalTrials.gov		NCT00014651
Date Submitted to PDQ		2001-03-07
Information Last Verified		2006-08-29
NCI Grant/Contract Number		P30-CA15083

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