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