drugset
drugset / Trial / NCT00061815

Study of Cetuximab, Oxaliplatin, 5-FU/LV Versus Oxaliplatin, 5-FU/LV in Patients With Previously Treated Metastatic, EGFR-Positive Colorectal Cancer

NCT00061815 ↗

Phase 3 Completed 102 enrolled Eli Lilly and Company Bristol-Myers Squibb · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone.

Timeline

Start
2003-03
Primary completion
2004-12
Completion
2005-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Background Leucovorin Small molecule 200 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 600 mg/m2 Intravenous

Indications

colorectal cancer