Phase II trial of two-weekly gemcitabine in patients with advanced biliarytract cancer

Background: Patients with advanced biliary tract carcinoma face a dismal pr ognosis as no effective palliative therapy has been defined. The aim of the present phase II investigation was to evaluate the therapeutic efficacy an d tolerance of a two-weekly high-dose gemcitabine regimen in this patient p opulation. Patients and methods: Thirty-two consecutive patients with locally unresect able or metastatic biliary tract cancer were enrolled in this multicenter p hase II trial. Treatment consisted of gemcitabine 2200 mg/m(2) given as a 3 0-min intravenous infusion every two weeks for a duration of six months unl ess there was prior evidence of progressive disease. Results: After a median number of 12 treatment courses, 7 of 32 (22%) patie nts had a partial response that lasted for a median duration of 6.0 months (range 3.5-10.0). Fourteen additional patients (44%) had stable disease, wh ereas eleven patients (34%) progressed despite therapy. The median time to progression was 5.6 months (range 1.8-13.0); median survival time was 11.5 months (range 3.0-24.0), and the probability of surviving beyond 12 months was 44%. The tolerance of treatment was remarkable with only two patients e ach experiencing grade 3 leukocytopenia, granulocytopenia and/or thrombocyt openia, and one patient had grade 3 anaemia. Similarly, nonhaematologic sid e effects were infrequent, and generally mild to moderate. Conclusions: Two-weekly high-dose gemcitabine seems to represent a potentia lly effective, safe and well-tolerated regimen for the palliative treatment of patients with advanced biliary tract cancer.