Modulation of fluorouracil by methotrexate, leucovorin, and cisplatin (M-FLP) in the treatment of advanced pancreatic cancer - A phase II study of the Italian Oncology Group for Clinical Research (GOIRC)

The objective of this trial was to evaluate the activity and tolerability o f biomodulation of 5-fluorouracil by leucovorin, methotrexate, and platinum in patients with advanced measurable disease. Thirty-five patients with hi stologically or cytologically proven adenocarcinoma of the pancreas were tr eated with methotrexate (100 mg/m(2) in 500 ml 5% dextrose in a 2-hour infu sion, day 1), 5-fluorouracil (800 mg/m(2)/day, i.v. in continuous infusion from days 2 to 5) plus 1-leucovorin (7.5 mg/m(2) given per os every 6 hours , from days 2 to 5) and platinum (60 mg/m(2) i.v., day 2), every 28 days. F our partial responses (12%; exact 95% confidence interval: 1-23%) were obta ined in 34 evaluable patients with a median survival time of 49 weeks (rang e, 20-77 weeks). Ten (29%) of 34 patients had stable disease. Median time t o treatment failure from the beginning of therapy was 11 weeks (range, 4-59 weeks) and median survival time was 20 weeks (range, 4-77 weeks). The most common grade III-IV toxicities were diarrhea (15%), stomatitis (41%), and vomiting (17%). Hematologic toxicity was mild. There were no therapy-relate d deaths. In conclusion, this trial did not report an increase or improveme nt in response rate and survival rates, and this regimen cannot be recommen ded as effective therapy for advanced pancreatic cancer.