Trial Information

Study Of Gemcitabine, Leukovorin, And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas

OBJECTIVES: I. Determine the response rate, in terms of WHO objectives and clinical benefit,
in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma treated
with gemcitabine, leucovorin calcium, and fluorouracil. II. Determine the tolerance of this
regimen in this patient population. III. Determine the survival without disease progression
in patients treated with this regimen. IV. Determine the overall survival in patients
treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive leucovorin calcium IV over 2 hours
followed by fluorouracil IV over 24 hours on day 1 followed by gemcitabine IV over 80-150
minutes on day 2. Treatment repeats every 2 weeks for a minimum of 6 courses in the absence
of disease progression or unacceptable toxicity. Patients achieving complete response may
continue chemotherapy for up to 1 year. Patients with locally advanced disease after 3
months of chemotherapy may receive concurrent radiotherapy with chemotherapy for 5 weeks, or
may undergo surgical resection. Fluorouracil-based chemotherapy (with or without
radiotherapy) may then resume after surgery. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.