Safety of Cetuximab and Oxaliplatin/5-FU/FA/Irinotecan in First-Line Treatment of Metastatic Colorectal Cancer

Inclusion Criteria: * Diagnosis of non-resectable, histologically confirmed, epithelial growth factor receptor(EGFR)-positive or negative colorectal cancer * WHO Performance status 0 or 1 * Signed written informed consent * ≥ 18 years of age * Effective contraception for both male and female subjects if the risk of conception exists * Adequate bone marrow function: neutrophil blood cell count (NBC) ≥ 1.5 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, hemoglobin ≥ 5.96 mmol/L (10 g/dL) * Adequate liver and renal function: bilirubin ≤ 1.5 x upper normal level (UNL) and not increasing more than 25% within the last 4 weeks; ASAT and ALAT ≤ 5 x UNL; serum creatinine ≤ 1.5 x UNL. Exclusion Criteria: * Previous exposure to epidermal growth factor receptor-targeting therapy * Previous chemotherapy for colorectal cancer except for adjuvant treatment with progression of disease documented \> 6 months after end of adjuvant treatment or 5-FU in combination with radiotherapy for rectal cancer * Radiotherapy or major abdominal or thoracic surgery within the last 4 weeks before inclusion. * Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy. * Investigational agents or participation in clinical trials within 30 days before start of the treatment in study. * Clinically relevant coronary disease or myocardial infarction within 12 months before study entry. * Peripheral neuropathy \> CTC (Common Toxicity Criteria)grade I * Inflammatory bowel disease * Previous malignancy (except for colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment) * History of severe psychiatric illness * Drug or alcohol abuse * Known hypersensitivity reaction to any of the components of study treatment * Pregnancy (absence to be confirmed by b-hCG (pregnancy-) test) or lactation period * Brain metastasis and/or leptomeningeal disease (known or suspected) * Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease