A phase II study of axitinib for biliary tract cancer refractory to gemcitabine-based chemotherapy

INTERVENTION: Administration of axitinib CONDITION: Unresectable or recurrent bilary tract cancer PRIMARY OUTCOME: Progression free survival SECONDARY OUTCOME: toxicity, objective response rate, overall survival and biomarkers at the baseline INCLUSION CRITERIA: 1) Diagnosed as biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer 2) Recurrent or unrespectable biliary tract cancer 3) Histologically proven papillary adenocarcinoma, tubular adenocarcinoma, or adenosquamous carcinoma for extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer patients. Histologically proven adenocarcinoma for intrahepatic cholangiocarcinoma 4) Without CNS metastasis 5) Without moderate or more ascites/pleural effusion 6) Progressive disease under gemcitabine‐based chemotherapy or discontinuation of gemcitabine‐based chemotherapy due to adverse events 7) Life expectancy of 12 weeks or more 8) More than 2 weeks between the last administration of the prior chemotherapy regimen and study entry 9) Evidence of unidimensionally measurable disease 10) Eastern Cooperative Oncology Group performance statu