Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.
Metastatic Colorectal Cancer
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring capecitabine, irinotecan, cetuximab, oxaliplatin, colorectal cancer
Eligibility Criteria
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.