5-Fluorouracil, mitomycin, and doxorubicin (FAM) in carcinoma of the biliary tract.

A phase II trial of the regimen 5-fluorouracil, doxorubicin, and mitomycin C (FAM) was conducted in 17 patients with advanced or recurrent biliary tract cancer. Among 14 patients with measurable disease, 31% achieved a partial response. An additional seven patients evidenced stabilization of disease for periods of three to 18+ months. One patient with advanced but unmeasurable tumor has survived 72 months after 12 cycles of treatment. There was no serious life-threatening toxicity, and with appropriate dosage adjustment, the drug was administered to patients with mild hepatic insufficiency. We recommend the initiation of a larger controlled trial and a potential application with radiotherapy for patients with less advanced disease.