drugset / Trial / NCT00658593

Gemcitabine With/Out Capecitabine in Locally Advanced, Unresectable, or Metastatic Biliary Cancer

NCT00658593 ↗

Phase 3 Terminated 19 enrolled NCIC Clinical Trials Group
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

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 650 mg/m2 Oral
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous