A Clinical Trial Phase II of Calcitriol in Combination With 5-fluorouracil, Mitomycin C and Leucovorin in an Open Label-non-randomized Study to Evaluate the Tumor Response in Patients With Advanced Intrahepatic Cholangiocarcinoma
- OUTLINE: This is a dose-limiting toxicity study of calcitriol.
- EVALUAITON: During the initial phase, 14 patients will be accrued for this study. If
the number of patient's response to calcitriol and 5-fluorouracil/mitomycin
C/leucovorin is less than 1/14, the study will be stopped. However there is one patient
who responses to calcitriol and 5-fluorouracil/mitomycin C/leucovorin, the new 14
patients will be accrued during the secondary phase of study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess safety and tolerability of calcitriol in combination with 5-fluorouracil/mitomycin C/leucovorin.
Vajarabhongsa Bhudisawasdi, MD
Department of Surgery, Faculty of Medicine, Liver fluke and cholangiocarcinoma research center, Khon Kaen University
Thailand: Khon Kaen University Ethics Committee for Human Research