PHASE-II STUDY OF PACLITAXEL THERAPY FOR UNRESECTABLE BILIARY TREE CARCINOMAS

Purpose: To evaluate the efficacy of paclitaxel administered to patien ts with unresectable adenocarcinomas of the gallbladder and biliary tr ee over 3 hours every 21 days. Patients and Methods: Fifteen patients with unresectable and/or metastatic carcinoma of the gallbladder and b ile ducts received intravenous paclitaxel over 3 hours after premedica tion with dexamethasone, diphenhydramine, and cimetidine. Treatment wa s repeated every 21 days, and one complete course of therapy was compr ised of two such 21-day treatment cycles. The initial dose of paclitax el was 170 mg/m(2), and this was elevated to 200 mg/m(2) due to tolera nce within the initial patient cohort. Results: All patients were asse ssable for both toxicity and response: 11 with bile duct cancer and fo ur with gallbladder carcinoma. Forty-three cycles of therapy were deli vered during the trial (median, two), and one patient remains on treat ment. No complete or partial responses were noted, although two patien ts achieved minor responses that lasted 2 and 2+ months, respectively, There were no deaths on this study, and all but one of the patients i s still olive. The therapy wets well tolerated, and hematologic and mu cosal toxic effects were moderate and readily reversible, although sig nificant neuromuscular adverse effects were noted. Conclusion: These f indings indicate that paclitaxel, administered on this schedule, is to lerable, but is unlikely to have activity in metastatic carcinomas of the biliary tree, It is unclear whether a different regimen of paclita xel, or another taxane, may have activity in these neoplasms. (C) 1996 by American Society of Clinical Oncology.