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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent

Criteria

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