drugset / Trial / NCT00201305
Gemcitabine Plus High-Dose 5-Fu/Leucovorin in the Treatment of Advanced or Metastatic Carcinoma of the Biliary Tract
Phase 2
Completed
50 enrolled
National Health Research Institutes, Taiwan
Chang Gung Memorial Hospital · collabChanghua Christian Hospital · collabChi Mei Medical Hospital · collabChina Medical University Hospital · collabMackay Memorial Hospital · collabNational Cheng-Kung University Hospital · collabNational Taiwan University Hospital · collabTaipei Veterans General Hospital, Taiwan · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label phase II trial with weekly gemcitabine plus high-dose 5-FU/leucovorin infusion (HDFL) for patients with advanced or metastatic carcinoma of the biliary tract. The primary endpoint is patients' response and the secondary endpoints are chemotherapy-related toxicity, time to disease progression and overall survival. .
Timeline
- Start
- 2002-07
- Primary completion
- —
- Completion
- 2012-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Leucovorin | Small molecule | 300 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2000 mg/m2 | Intravenous |