Safety and Efficacy Study of Combination Therapy With Cetuximab and FOLFOX4 in Patients With Colorectal Cancer

Inclusion Criteria:

* Written informed consent.
* Men and women \< 75 years
* Histologically confirmed diagnosis of CRC
* Metastatic colorectal carcinoma with exclusive non-resectable hepatic metastases, due to fulfillment of one of the following criteria:

  1. Number of hepatic metastases \> or= 4;
  2. Size of one or more hepatic metastases \> 5 cm diameter;
  3. Vascular involvement and/or poor site that prevent complete resection of hepatic disease and/or require resection with the remaining liver mass less than 25-30% of functional liver.
* Presence of at least one lesion detectable by two-dimensional measurement.
* Karnofsky functional status \>or=70% at the time of enrollment in study
* Life expectancy greater than 3 months.
* Patients must not have received chemotherapy for advanced/metastatic disease.
* Patients with the following characteristics will be enrolled:

  1. Recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with disease-free period \> 6 months following conclusion of treatment.
  2. Recurrence after surgical and/or radiotherapy treatment without adjuvant systemic treatment.
  3. De novo diagnosis of disease.
* Proper liver function, defined by aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) \< or = 2.5 x ULN (\< or = 5 x ULN if there are hepatic metastases) and total bilirubin count \< 1.5 x ULN.
* Proper kidney function, defined as serum creatinine \< 1.5 x ULN.
* Proper hematological function, defined as neutrophil count \> or = 1.5 x 109/l , platelets \> or = 100 X 109/l and hemoglobin \> or = 9 g/dl.
* Effective birth control method for men as well as women if there is possibility of pregnancy

Exclusion Criteria:

* Documented or suspected cerebral and/or leptomeningeal metastases.
* Metastasis in any other non-hepatic site, including extrahepatic lymph node metastases.
* Surgery (excluding biopsy for diagnosis) and/or radiotherapy within 4 weeks prior to enrollment in the study.
* Participation in another clinical trial with medication in the past 30 days.
* Chronic, concomitant administration of systemic immunotherapy, chemotherapy, hormone therapy or any other investigational drug.
* Prior malignant tumour in past 5 years, except history of basal cell skin carcinoma or pre-invasive cervical carcinoma.
* Any investigational drug during the 4 weeks prior to enrolment.
* Prior administration of monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted treatment.
* Prior participation in study in which treatment with cetuximab can be assigned (whether or not treatment with cetuximab is received)
* Acute or subacute intestinal occlusion or history of inflammatory intestinal disease.
* Evidence of grade 3 or 4 allergic reaction to any of the treatment components.
* Clinically relevant peripheral neuropathy.
* Clinically relevant myocardial disease or history of myocardial infarction in the past 12 months.
* Known abuse of alcohol / drugs, Legal incapacity or limited legal capacity.
* Any medical or psychological disorder which, in the opinion of the investigator, does not allow the patient to conclude the study or sign the informed consent.
* Pregnant or nursing woman