Phase II Trial of Combination Chemotherapy for Pancreatic Cancer with 5-Fluorouracil, Mitomycin C, and Hexamethylmelamine

Abstract

A combination consisting of hexamethylmelamine 150 mg/m² D2–15, mitomycin C 10 mg/m² D2 and 5-fluorouracil 30 mg/kg/day as a continuous infusion for 5 days, in 4–5 week cycles, underwent phase II trial as primary therapy for 21 patients with regional and metastatic cancer of the pancreas. Median survival from the onset of therapy was 43 weeks. There were 2 complete responses, 4 minor responses and 6 stable diseases for more than 6 months. Nonambulatory patients were among the responders. There was only 1 life-threatening toxicity (thrombocytopenia) and only 33% of patients had clinically silent severe hematological toxicity. The regimen is well tolerated, active and associated with excellent survival. This regimen is suitable for further confirmatory trials.