drugset / Trial / NCT00048126

A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer

NCT00048126 ↗

Phase 2 Completed 57 enrolled Hoffmann-La Roche
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study will assess the efficacy and safety of continuous oral Xeloda administration in combination with intravenous irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.

Timeline

Start
2001-07
Primary completion
2005-01
Completion
2005-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg Oral
Subject Irinotecan Small molecule 100 mg/m2 Intravenous

Indications