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

Phase 2

Completed

• Conditions: First Line Metastatic Colorectal Cancer
• Interventions: Drug: Irinotecan

• Registration Number: NCT01963182
• Lead Sponsor: Centre Jean Perrin

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-16
• Status Verified: 2019-12
• Primary Completion: 2019-12
• Study Completion: 2019-12-09
• Last Update Submitted: 2019-12-24
• Last Update Posted: 2019-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
irinotecan dose based on genetic polymorphism of UGT1A1	Irinotecan	-

Primary Outcome Measures

Name	Time	Method
severe toxicity (according to NCI-CTC cotation) and response with adapted dose of irinotecan	during the treatment (an expected average of 7 months)

Secondary Outcome Measures

Name	Time	Method
evaluation of treatment efficacy (progression-free survival, duration of response)	to progression (1 year)
Study of the blood concentration (pharmacokinetic) of irinotecan, the SN38 and SN38-G, and bevacizumab	during the first 24 hours of the first cure

Trial Locations

Locations (3)

Clinique de la Châtaigneraie; 🇫🇷 Beaumont, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

CHU Estaing; 🇫🇷 Clermont-Ferrand, France