XELOX Plus Cetuximab as First-Line Therapy in Patients With Metastatic Colorectal Cancer

Inclusion Criteria: * Signed written informed consent, prior any study-specific procedures * Male or female \> = 18 years of age * Histologically confirmed adenocarcinoma of the colon or rectum with metastatic disease not eligible for surgery with curative intent - in case of a unique metastatic lesion this should be confirmed by biopsy * ECOG performance status \< 1 at study entry * Immunohistochemical evidence of EGFR expression on tumour tissue * Presence of at least one unidimensional measurable lesion with a diameter \> 20mm by conventional CT scan or MRI, and 10mm by spiral CT scan, according to the RECIST criteria (Index lesion(s) must not lie within an irradiated area) * Have not received any Chemotherapy regimen for metastatic disease * Life expectancy of \> 3 months * Neutrophils \> = 1.5 x 109/L, platelet count \> = 100 x 109/L, and haemoglobin \> = 9 g/dL. * Bilirubin level either normal or 1.5 x ULN * ASAT and ALAT \< = 2.5 x ULN (\< = 5 x ULN in case of liver metastasis) * Alkaline phosphatase \< = 2.5 x ULN or \< = 5 x ULN in case of liver metastasis or \< = 10 x ULN in case of bone metastases * Serum creatinine \< = 1.5 x ULN or CrCl \> 50 ml/min (Cockroft and Gault formula) * Negative Pregnancy test within one week before treatment start, if applicable Exclusion Criteria: * Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. * Adjuvant or neo-adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is \> 6 months and the patient have not progressed during treatment * Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry * Prior radiotherapy is permitted if it was not administered to target lesions selected for this study * Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol * Any investigational agent(s) within 4 weeks prior to entry * Previous exposure to EGFR-pathway targeting therapy * History of evidence upon physical examination of CNS disease (e.g. primary brain tumour, seizure not controlled with standard therapy, any brain metastasis or history of stroke) * Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months * Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease * Acute or subacute intestinal occlusion or history of inflammatory bowel disease * Pre-existing neuropathy \> grade 1 * Known grade 3 or 4 allergic reaction to any of the components of the treatment. * Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for \> = 5 years will be allowed to enter the trial) * Known drug abuse/ alcohol abuse * Legal incapacity or limited legal capacity * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent * Pregnant or lactating women * Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study * Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome * Known dihydropyrimidine dehydrogenase deficiency