drugset / Trial / NCT00658593
Gemcitabine With/Out Capecitabine in Locally Advanced, Unresectable, or Metastatic Biliary Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether gemcitabine is more effective when given together with or without capecitabine in treating patients with biliary cancer. PURPOSE: This randomized phase III trial is studying giving gemcitabine together with capecitabine to see how well it works compared with giving gemcitabine alone in treating patients with locally advanced, unresectable, or metastatic biliary cancer.
Timeline
- Start
- 2008-10-10
- Primary completion
- 2010-05-11
- Completion
- 2011-01-18
Outcome
Outcome not reported
Stopped (Enrollment): “due to poor accrual”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Capecitabine | Small molecule | 650 mg/m2 | Oral |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |