ABOUT THIS STUDY
- Has provided written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time without prejudice
- Ages between 18 and 85 years
- Histologically confirmed colorectal cancer
- No treatment for metastatic disease
- No irinotecan previously administered
- World Health Organization (WHO) performance status < 3
- Laboratory values :
- neutrophils > 1.5 x 10^9/L;
- platelet count > 100 x 10^9/L;
- serum creatinine < 130µmol/L;
- serum bilirubin < 2 x upper limit of normal (ULN);
- ASAT and ALAT < 2.5 x ULN;
- alkaline phosphatase < 5 x ULN.
- At least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- History of another malignancy except cured basal cell carcinoma of the skin or
carcinoma in situ of the uterine cervix, breast or bladder.
- Other concomitant anticancer therapy.
- Pregnant or lactating women.
- Women of childbearing potential unless using a reliable and appropriate contraceptive
- Symptomatic cerebral or leptospiral metastasis.
- Intestinal obstruction.
- Uncontrolled seizures (diabetes, severe infection).
- Clinically significant cardiac disease.
- Central nervous system disorders or severe psychiatric disability.
- Participation in any investigational study within 4 weeks.
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