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