Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.

Inclusion Criteria:

* Histologically confirmed metastatic colorectal cancer.
* EGF-receptor testing.
* No prior chemotherapy for colorectal cancer (except adjuvant chemotherapy with an interval ³ 6 months).
* No prior therapy with topoisomerase-1 inhibitors, no prior therapy directed against the EGF-pathway.
* No prior surgery (except diagnostic biopsy) or radiation therapy 4 weeks before start of study treatment.
* Measurable disease (diameter ³ 20mm, diameter ³ 10mm with spiral-CT).
* Male and female patients ³ 18 years, £ 75 years. Karnofsky PS ³ 70%. Life expectancy ³ 3 months. Effective contraception if risk of conception exists.
* Adequate bone marrow, liver and renal function (leucocytes ³3.000/µl, neutrophils ³1.500/µl, platelets ³100.000/µl, hemoglobin ³9g/dl, bilirubin £1,5x ULN, ASAT and ALAT £3x ULN (£5x ULN with liver metastasis), serum creatinine £1,5x ULN).
* Written informed consent.

Exclusion Criteria:

* Concurrent treatment of colorectal cancer (except study medication).
* EGF-receptor testing not possible.
* Known DPD-deficiency (no particular screening necessary). Known Gilbert-Meulengracht-Syndrome (no particular screening necessary).
* Known or expected contraindication against study medication.
* Participation in other studies during 30 days before study entry.
* Prior myocardial infarction, severe renal insufficiency (creatinine clearance £30ml/min).
* Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment and no sign of disease during 5 years).
* Known or suspected cerebral metastasis.
* History of inflammatory bowel disease. Symptomatic peritoneal carcinomatosis.
* Drug or alcohol abuse. Lack of adequate legal capacity.
* Breast-feeding or pregnant women.
* Concurrent medication with Sorivudine and analoga, anticoagulation with Cumarine or derivatives.