A phase II trial of irinotecan (CPT-11) for unresectable biliary tree carcinoma

Background: Unresectable adenocarcinomas of the biliary tree have a very po or prognosis. No good chemotherapeutic regimen is available. Irinotecan has not yet been fully tested in this disease. We evaluated its activity in un resectable bile duct cancers. Patients and methods: Twenty-five consecutive eligible patients at our two institutions were treated with irinotecan at a starting dose of 125 mg/m(2) . A cycle consisted of once-a-week treatments for four consecutive weeks, f ollowed by two weeks of rest. All patients were required to have histologic ally confirmed diagnosis, clinically documented metastatic or unresectable carcinoma and measurable disease. Patients were evaluated for response, tox icity, and survival. Results: A total of 83 cycles of therapy were delivered. Two patients had a partial response (8%; 95% confidence interval (CI): 0%-18%) and ten additi onal patients had stable disease for at least two months (40%; 95% CI: 20.8 %-59.2%). The therapy was well tolerated, with moderate myelosuppression an d diarrhea as the main toxicities. The overall median survival was 10 month s. Conclusions: Irinotecan has minimal activity in biliary tree carcinomas, bu t is well tolerated with appropriate supportive care, and produces occasion al objective responses.