High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study

Inclusion Criteria: 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 Exclusion Criteria: 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