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

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 2

Conditions: Neoplasm Metastasis; Colorectal Cancer

Treatments: Biological: Cetuximab; Drug: Oxaliplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00125034

EMR 62202-047

Details and patient eligibility

About

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.

Enrollment: 344 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

344 participants in 2 patient groups

Cetuximab Plus FOLFOX-4

Experimental group

Treatment:

Biological: Cetuximab

FOLFOX-4 Alone

Active Comparator group

Treatment:

Drug: Oxaliplatin