drugset / Trial / NCT00063141

Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer

NCT00063141

Phase 3 Completed 1302 enrolled Eli Lilly and Company Bristol-Myers Squibb · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.

Timeline

Start
2003-04
Primary completion
2006-06
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Comparator Irinotecan Small molecule 350 mg/m2 Intravenous

Indications