RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemotherapy following surgery may be an effective treatment for pancreatic cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with stage II or stage III pancreatic cancer that has not been surgically removed.
OBJECTIVES: I. Assess the one year overall survival rate of patients with advanced, unresectable pancreatic cancer treated with fluorouracil, leucovorin, mitomycin and dipyridamole. II. Assess the response rate in this group of patients. III. Evaluate the frequency and severity of the toxic effects associated with this therapy. IV. Assess the rate of resectability in patients who respond to therapy. OUTLINE: All patients undergo surgical placement of an indwelling central venous line. Patients receive fluorouracil IV by continuous infusion on days 1-28, leucovorin calcium IV on days 1, 8, 15, and 22, oral dipyridamole on days 1-28, and mitomycin IV every 6 weeks starting on day 1. Treatment repeats every 6 weeks for 4 courses. Patients with a partial or complete response are reevaluated for possible surgical resection. Resected patients resume chemotherapy 4-8 weeks after surgery for an additional 16 weeks. Patients are followed every 6 months for 2 years, then annually until death. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
75mg/dose, PO, Days 1-28 of 5 week cycle
200 mg/m\^2/day, continuous IV, Days 1-28 of 5 week cycle
30 mg/m\^2/day, IV, Days 1,8,15,22 of 5 week cycle
Overall Survival
Time frame: One year
Response rate in patients with measurable disease
Time frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Toxicities
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Resectability of patents who respond to this regimen
Time frame: From date of registration until the date of patients achieving complete or partial response assessed up to 100 months
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10 mg/m\^2, IV, Day 1 of 6 week cycle (for only 4 cycles)
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