Comparison of 5-fluorouracil, doxorubicin and mitomycin C with 5-fluorouracil alone in the treatment of pancreatic-biliary carcinomas.

In this multicenter randomized trial, the efficacy of combination chemotherapy using 5-fluorouracil, doxorubicin and mitomycin C (arm A) was compared with that of 5-fluorouracil alone (arm B) in 81 patients with nonresectable carcinomas of the pancreas or biliary tract. There were no significant differences between treatment arms regarding the median time to progressive disease, median survival time, palliative effects or toxicities. It was concluded that combination chemotherapy is feasible but cannot be recommended.