Bi-weekly Cetuximab Combined With 5-fluorouracil/Leucovorin/Oxaliplatin (FOLFOX-6) in Metastatic Colorectal Cancer

Inclusion Criteria: * Histologically proven metastatic colorectal cancer * Molecular test showing no mutation in the k-ras gene of colorectal carcinoma cells * Male and female subjects ≥ 18 years of age * 1st occurrence of metastatic disease (not curatively resectable) * Life expectancy ≥ 12 weeks * Presence of at least 1 bi-dimensionally measurable index lesion (not in an irradiated area) * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at study entry * Adequate bone marrow reserve: leucocytes ≥ 3.0 x 109/l with neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, haemoglobin ≥ 6.21 mmol/l (10 g/dl) * Aspartate-aminotransferase (ASAT) and alanine-aminotransferase (ALAT) ≤ 2.5 x upper reference range, in case of liver metastasis ≤ 5 x upper reference range * Serum creatinine ≤ 1.5 x upper reference range * Bilirubin ≤ 1.5 x upper reference range * Negative pregnancy test for female and effective contraception for both male and female subjects if the risk of conception exists * Signed written informed consent Exclusion Criteria: * Evidence for a mutation of the k-ras gene in the colorectal carcinoma cells * Previous exposure to epidermal growth factor receptor-targeting therapy * Prior chemotherapy for metastatic disease * Prior oxaliplatin based adjuvant chemotherapy or \< 6 months after end of adjuvant treatment * Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix * Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before registration * Concurrent chronic systemic immune therapy or hormone therapy not indicated in this study protocol * Creatinine clearance \< 30 ml/min * Known hypersensitivity reaction to any of the components of study treatment * Pregnancy (absence to be confirmed by ß-human chorionic gonadotropin (hCG) test) or lactation period * Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia * Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease * Brain metastasis (known or suspected) * Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent * Known alcohol or drug abuse * Participation in another clinical study within the 30 days before registration * Peripheral neuropathy \> grade 1 * Significant disease which, in the investigator's opinion, would exclude the patient from the study * Legal incapacity or limited legal capacity