A phase II study of weekly 24 h infusion of high-dose 5-fluorouracil in advanced pancreatic cancer

No single agent or combination chemotherapy protocol, wit the exception of gemcitabine, has so far proven superior to standard bolus 5-fluorouracil re gimes for the treatment of advanced pancreatic cancer. The present phase II trial was designed to stud whether the effectivity of 5-fluorouracil can b e improved with a weekly high-dose 5-fluorouracil schedule. 26 patients wit h cytologically or histologically verified, metastasized (n = 21) or locall y advanced (n = 5) previously untreated adenocarcinoma of the pancreas were included in this study. Treatment consisted of weekly applications of 2,60 0 mg/m(2) 5-fluorouracil as 24-h infusion on days 1, 8, 15, 22, 29, 36. Tre atment was repeated at day 50 and was continued until disease progression. Primary endpoints of the study were response rates and toxicity, secondary endpoints were survival and clinical benefit in terms of performance status , body weight and analgesia consumption. Toxicity of the regimen wa mild wi t only four instances of grade-3 toxicity. Response rates were 8% (95% CI = 1.2-13.7) with two partial remissions. Improvement of at least one paramet er of clinical benefit for greater than or equal to four most weeks was obs erved for 11.5% of the study patients. The most prominent effect was a tran sient stabilization of objective tumor measurements (48% [95% CI = 27.8-68. 7]) and individual parameters of clinical benefit (50-75%). Median survival was 248 days (95% CI = 164-459) for all patients included in the study. Th e present study indicates that the high-dose 5-fluorouracil regimen shows w eak activity in advanced pancreatic cancer which seems comparable to gemcit abine.