MedDataX Logo

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

NCT ID: NCT01963182

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2019-12-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

First Line Metastatic Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

irinotecan dose based on genetic polymorphism of UGT1A1

Group Type EXPERIMENTAL

Irinotecan

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Irinotecan

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Jean Perrin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hervé DEVAUD, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Jean Perrin

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinique de la Châtaigneraie

Beaumont, , France

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

CHU Estaing

Clermont-Ferrand, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Ginzac A, Thivat E, Petorin C, Richard D, Herviou P, Molnar I, Devaud H, Creveaux I, Ferrer F, Authier N, Jary M, Pezet D, Durando X. A phase-II study based on dose adjustment according to UGT1A1 polymorphism: is irinotecan underdosed in first-line FOLFIRI regimen for mCRC? Cancer Chemother Pharmacol. 2024 Mar;93(3):225-236. doi: 10.1007/s00280-023-04603-x. Epub 2023 Nov 7.

Reference Type DERIVED
PMID: 37932443 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-001275-21

Identifier Type: -

Identifier Source: org_study_id