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.