Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer (IriGen)

Centre Jean Perrin

Status and phase

Completed

Phase 2

Conditions

First Line Metastatic Colorectal Cancer

Treatments

Drug: Irinotecan

Study type

Interventional

Funder types

Other

Identifiers

NCT01963182

2013-001275-21

Details and patient eligibility

About

This prospective, non randomized multicenter phase II study, will determine the feasibility of individualized dose of irinotecan with the UGT1A1 polymorphism, in patients with metastatic colorectal cancer treated with FOLFIRI.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Colorectal cancer histologically or cytologically proven
Indication of treatment according to the FOLFIRI + / - bevacizumab or cetuximab or panitumumab
Age> 18 years
Presence of at least one measurable target by RECIST
Life expectancy> 3 months
Satisfactory biological functions (renal, hepatic and hematologic)
Affiliation to a social security scheme (or be the beneficiary of such a plan) under the terms of the Act of August 9, 2004
Patient has signed, after informing the informed consent form

Exclusion criteria

Patients of childbearing age and not using effective contraception during treatment and for at least three months after the end of treatment with irinotecan and at least six months after the end of treatment with bevacizumab, cetuximab or panitumumab and patient pregnant or nursing
Patient with another pathology deemed incompatible with the entry in the protocol
Prior treatment in metastatic
Patients taking antiepileptic
Allergic reaction or intolerance to irinotecan
Heart failure , kidney , bone marrow , liver or respiratory
Higher bilirubin 1.5 times the upper limit of normal
Significant psychiatric or neurological abnormality
Infectious syndrome requiring treatment with antibiotics or antiviral long-term
Patients with chronic inflammatory bowel disease and / or bowel obstruction
Contraindication Association St. John's wort and yellow fever vaccine
Against Heart indication 5-FU
Concurrent treatment with a drug test , participation in a clinical trial within <30 days
Patient refused to sign the consent