Multicenter Phase II Clinical Trial of Genexol-PM® with Gemcitabine in Advanced Biliary Tract Cancer

This multicenter phase II clinical trial was designed to evaluate the efficacy and safety of weekly Genexol-PM (R) and gemcitabine combination chemotherapy in patients with unresectable or metastatic biliary tract cancer. Patients and Methods: Patients received 100 mg/m2 Genexol-PM (R) r and 1,000 mg/m2 gemcitabine intravenously on days 1 and 8 every 21 days. Results: Out of 39 patients, there were 10 partial responses (25.6%) and 18 with stable diseases (46.2%) were confirmed with median response duration 4.1 months. The median progression- free survival was 5.9 +/- 1.6 months and overall survival 11.9 +/- 1.4 months. The median number of cycles administered was 4.0 (range= 1-10). Grade 3 or more neutropenia occurred in 12 patients (26.7%). The most common grade 3/4 non-hematological toxicities were febrile neutropenia (13.4%) and elevation of liver enzymes (6.7%).Conclusion: Weekly Genexol-PM (R) r combined with gemcitabine demonstrated sufficient antitumor activity to warrant further development when used as first-line chemotherapy for advanced biliary tract cancer.