Cetuximab in Neoadjuvant Treatment of Non-Resectable Colorectal Liver Metastases (CELIM)

Inclusion Criteria:

* Patients with non-resectable, histologically confirmed, synchronous or metachronous colorectal liver metastases. Patients with non-resectable metastases are defined as; patients with five or more liver metastases; and/or patients with liver metastases that are technically non-resectable (local surgeon in cooperation with local radiologist will define non-resectability on the basis of remaining functional liver tissue, infiltration of all liver veins, infiltration of both liver arteries, both portal branches or both bile ducts).
* Patients with simultaneous liver metastases are eligible, if the primary tumor has been resected at least 1 month prior to chemotherapy.
* Karnofsky Performance Status ≥ 80
* Informed consent
* Adequate bone marrow function, liver and renal function (neutrophils \> 1.5 x 10\^9/l; thrombocytes \> 100 x 10\^9/l; hemoglobin \> 8.0 g/l; bilirubin ≤ 1.5 x upper limit of normal \[ULN\] and not increasing more than 25% within the last 4 weeks; ALAT and ASAT \< 5 x UNL; serum creatinine ≤ 1.5 x UNL)
* Age ≥ 18 years

Exclusion Criteria:

* Any evidence of extrahepatic metastases, lymph node metastases and primary tumor recurrence
* Prior chemotherapy (except adjuvant chemotherapy with an interval of ≥ 6 months)
* Previous exposure to EGFR (epidermal growth factor receptor)-targeting therapy
* Radiotherapy or major abdominal or thoracic surgery (excluding diagnostic biopsy or port implantation) ≤ 4 weeks before study entry
* Concurrent 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 grade I
* Inflammatory bowel disease
* Previous malignancy (except 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
* Breast feeding or pregnant women, no effective contraception if risk of conception exists (male and female patients)