drugset / Trial / NCT00202787
Safety and Efficacy Study of Combination Therapy With Cetuximab and FOLFOX4 in Patients With Colorectal Cancer
Phase 2
Completed
136 enrolled
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine confirmed objective response rate to combination therapy with cetuximab and FOLFOX4 or FOLFOX4 alone in patients with CRC and non-resectable hepatic metastases
Timeline
- Start
- 2005-02
- Primary completion
- 2009-02
- Completion
- 2009-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 600 mg/m2 | — |
| Background | Leucovorin | Small molecule | 200 mg/m2 | — |