A phase II trial of biweekly oxaliplatin with simplified schedule of 48-h infusion of high-dose 5-fluorouracil and leucorvin for advanced biliary tract carcinoma

Purpose: Advanced biliary tract carcinoma (BTC) is a dismal disease with no standard chemotherapy. We investigated efficacy and toxicity of biweekly oxaliplatin with 48-h infusion of 5-FU/LV in advanced BTC. Methods: All patients had histologic confirmation of BTC, at least one measurable site of disease, and had received no prior chemotherapy. Patients were older than 20 years with ECOG performance scores (PS) of 0-2. Treatment involved 2-h infusion of oxaliplatin (85 mg/m²) diluted in D5W 500 ml followed by 48-h infusion of 5-FU (3,000 mg/m²) and LV (100 mg/m²) biweekly. Response evaluation was based on RECIST criteria and was carried out every two courses of treatment; toxicity evaluation was based on NCI common toxicity criteria version 3.0. Results: From August 2005 to December 2006, 34 chemotherapy-naive patients with advanced BTC were enrolled and 32 intention-to-treat patients were evaluated. Partial response was 18.8%, stable disease was 31.3%, resulting in a disease control rate of 50.0%. Median time to progression and survival was 3.7 and 7 months, respectively. The most common grade 3/4 toxicities were neutropenia 15.6% (5/32), stomatitis 9.4% (3/32), thrombocytopenia 6.3% (2/32), diarrhea 6.3% (2/32) and neuropathy 3.1% (1/32). No treatment-related deaths occurred. Conclusions: The biweekly OXA and 48-h infusion of 5-FU/LV in patients with advanced BTC showed tolerable and efficacy equivalent to other combination regimens treatment.