High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study
- Histologically or cytologically proven adenocarcinoma of the colon or rectum
- Documented progressive metastatic disease
- Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI
according to response evaluation criteria in solid tumours (RECIST)
- WHO performance status of 0 or 1
- Adequate laboratory values of haematology, liverfunction and renal function
- No previous chemotherapy for metastatic colorectal cancer
- Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except
curatively treated cancer free of disease for more than 10 years.
- Bowel obstruction or sub-obstruction. Crohn's disease, or ulcerative colitis.
- Other severe illness or medical condition such as unstable cardiac disease under
treatment, myocardial infarction within 6 months before inclusion.
- Active uncontrolled infection
- Other concomitant anticancer agent