drugset / Trial / NCT00502671

A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.

NCT00502671

Phase 4 Completed 228 enrolled Hoffmann-La Roche
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Timeline

Start
2007-07
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1250 mg/m2

Indications