Phase I-II Study of bi-Weekly Fixed Dose Rate Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma
Open, non-randomized phase I/II study.
Phase I part To find MTD and RFTD for the combination of gemcitabine, oxaliplatin and
Dose Escalating Schedule Dose level Dose Gemcitabine 10 mg/m2/min 600-1000 mg/m2 day 1 and
14 Capecitabine p.o. x 2 daily. 1000-1250 mg/m2 day 1-7 and 14-21 Oxaliplatin 60-80
mg/m2day 1 and 14 Drugs: G C O Level 1 600 1000 60 Level 2 800 1000 60 Level
3 1000 1000 60 Level 4 1000 1250 60 Level 5 1000 1250 80 Level 6 1200 1250 80 Start level:
Level 1, 3 patients per level
Phase II part The primary endpoint is the objective response rate The secondary endpoint is
toxicity, response duration and time to progression.
Gemcitabine Gemcitabine is given intravenously on day 1 and 14 with a fixed dose rate of 10
Oxaliplatin Oxaliplatin is given intravenously on day 1 and 14 as a 2 hours infusion.
Capecitabine Capecitabine is given orally and administered in tablets of 150 mg and 500 mg.
The dose is administered twice daily with 12 hours interval, in the morning and evening
during or latest 30 minutes after a meal.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Ulrik Lassen, MD., PH.D.
Rigshospitalet, Dept. of Oncology
Denmark: Danish Medicines Agency