Oxaliplatin and Cetuximab in First-line Treatment of Metastatic Colorectal Cancer (mCRC)

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA + oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for epidermal growth factor receptor (EGFR)-expressing mCRC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Cetuximab; Oxaliplatin

Criteria

Inclusion Criteria:

• First-line mCRC

• EGFR positive

• Bi-dimensional measurable index lesion

Exclusion Criteria:

• Previous exposure to EGFR-targeting therapy

• Previous oxaliplatin-based therapy

• Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment

• Radiotherapy

• Surgery

• Any other investigational drug in the 30 days before randomization

• Brain metastasis and/or leptomeningeal disease

• Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease