drugset / Trial / NCT00063141
Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Comparator | Irinotecan | Small molecule | 350 mg/m2 | Intravenous |