A Phase II Study of Outpatient Biweekly Gemcitabine-Oxaliplatin in Advanced Biliary Tract Carcinomas

Biliary tract carcinomas are uncommon but highly fatal malignancies. Unfortunately, most cases are ineligible for surgery at diagnosis with chemotherapy being the mainstay of treatment. The aim of this Phase II study was to evaluate the efficacy and safety of a biweekly outpatient regimen of gemcitabine plus oxaliplatin in cases of advanced biliary tract carcinomas. Forty patients with advanced, chemotherapy-naive biliary tract carcinomas were enrolled in the study between December 2005 and November 2009. All patients received the gemcitabine plus oxaliplatin treatment protocol as follows: gemcitabine 1000 mg/m(2) (30 m infusion) followed by oxaliplatin 85 mg/m(2) (2 h infusion) on days 1 and 15 of a 28-day cycle. The primary endpoint was the tumor control rate. Efficacy and safety analyses were done by intention to treat. The objective response rate was 27.5% and the tumor control rate was 65%. The median progression-free survival was 4 months and the median overall survival was 12 months. The tumor control was translated into a significant prolongation in overall survival. The regimen was generally well tolerated; Grade 3-4 toxicities were recorded in 25% of the patients with neutropenia being the most common (17.5%); Grade 3 sensory neuropathy was uncommon (2.5%). The study provides further evidence for the activity of gemcitabine plus oxaliplatin combination as a first-line treatment for advanced biliary tract carcinomas. This combination can be given safely as a convenient biweekly outpatient regimen.