EPIRUBICIN-SEQUENTIAL METHOTREXATE-5-FLUOROURACIL-LEUCOVORIN TREATMENT IN ADVANCED CANCER OF THE EXTRAHEPATIC BILIARY SYSTEM - A PHASE-II STUDY

A combination chemotherapy was used to treat patients with advanced ca ncer of the extrahepatic biliary system not amenable to surgical resec tion. Between February 1985 and April 1992, 22 consecutive patients en tered into the study; 17 (11 with extrahepatic bile duct cancer and 6 with gallbladder cancer) were evaluable for response and toxicity. The treatment schedule was as follows: epirubicin 20 mg/m2 given as a bol us, followed by methotrexate 150 mg/m2 as a 30-minute infusion, 1 hour later 5-fluorouracil 600 mg/m2 as a 30-minute infusion. Leucovorin re scue (15 mg orally every 6 hours for eight doses) was started 24 hours after methotrexate. This course was administered once a week in 3 suc cessive weeks followed by a 2 to 3 weeks rest period. A total of 174 c ourses was given. No objective tumor regression was observed. This reg imen was well tolerated, the main toxicity being gastrointestinal. The median survival time for the 17 evaluable patients was 9 months.