A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer

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