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)

December 24, 2019 updated by: Centre Jean Perrin

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beaumont, France, 63110
        • Clinique De La Chataigneraie
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Clermont-Ferrand, France, 63011
        • CHU Estaing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: irinotecan dose based on genetic polymorphism of UGT1A1

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hervé DEVAUD, MD, Centre Jean Perrin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 9, 2019

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (Estimate)

October 16, 2013

Study Record Updates

Last Update Posted (Actual)

December 26, 2019

Last Update Submitted That Met QC Criteria

December 24, 2019

Last Verified

December 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on First Line Metastatic Colorectal Cancer

Clinical Trials on Irinotecan

3
Subscribe