A Randomized Phase II-study to Evaluate the Safety and Efficacy of Capecitabine Plus Irinotecan Plus Cetuximab Compared to Capecitabine Plus Oxaliplatin Plus Cetuximab in First-line Treatment of Patients With Metastatic Colorectal Cancer.
- 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
- 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.
- 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
- 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