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

Ghent University Hospital (UZ)

Status and phase

Completed

Phase 2

Conditions

Advanced Colorectal Cancer

Treatments

Drug: Administration of high dose simplified folfiri

Study type

Interventional

Funder types

Other

Identifiers

2004/195

Details and patient eligibility

About

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

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

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