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.
Study summary:
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.
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