A Study of Combination of Gemcitabine, Oxaliplatin (GEMOX)-Sorafenib in Patients With Advanced Biliary Tract Cancer
Status:
Terminated
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to build on the efficacy of the GEMOX regimen by adding
Sorafenib in the treatment of Biliary Tract Cancer. Since there is no data on the combination
of these three agents, the investigators plan to evaluate the safety in a run-in phase I
portion in order to define the recommended phase II dose (RPTD). The phase II trial will
enroll 40 patients at the RPTD level within 2 years in order to provide a preliminary
estimate of progression-free survival (primary endpoint of the trial) in the target
population.