NCT00003018

S9700 Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer

A Phase II Trial of Infusional 5-Fluorouracil (5-FU), Calcium Leucovorin (LV), Mitomycin-C (Mito-C), and Dipyridamole (D) in Patients With Locally Advanced Unresected Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	dipyridamole	75mg/dose, PO, Days 1-28 of 5 week cycle
DRUG	fluorouracil	200 mg/m\^2/day, continuous IV, Days 1-28 of 5 week cycle
DRUG	leucovorin calcium	30 mg/m\^2/day, IV, Days 1,8,15,22 of 5 week cycle
DRUG	mitomycin C	10 mg/m\^2, IV, Day 1 of 6 week cycle (for only 4 cycles)

Timeline

• Start date: 1997-09-01
• Primary completion: 2002-01-01
• Completion: 2007-01-01
• First posted: 2004-04-22
• Last updated: 2013-01-03

Locations

84 sites across 1 country: United States