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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)

Primary Purpose

First Line Metastatic Colorectal Cancer

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Irinotecan
Sponsored by
Centre Jean Perrin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for First Line Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinique de la Châtaigneraie
  • Centre Jean Perrin
  • CHU Estaing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

irinotecan dose based on genetic polymorphism of UGT1A1

Arm Description

Outcomes

Primary Outcome Measures

severe toxicity (according to NCI-CTC cotation) and response with adapted dose of irinotecan

Secondary Outcome Measures

Study of the blood concentration (pharmacokinetic) of irinotecan, the SN38 and SN38-G, and bevacizumab
evaluation of treatment efficacy (progression-free survival, duration of response)

Full Information

First Posted
October 10, 2013
Last Updated
December 24, 2019
Sponsor
Centre Jean Perrin
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1. Study Identification

Unique Protocol Identification Number
NCT01963182
Brief Title
Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer
Acronym
IriGen
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First Line Metastatic Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
irinotecan dose based on genetic polymorphism of UGT1A1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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
Title
evaluation of treatment efficacy (progression-free survival, duration of response)
Time Frame
to progression (1 year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hervé DEVAUD, MD
Organizational Affiliation
Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique de la Châtaigneraie
City
Beaumont
ZIP/Postal Code
63110
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
CHU Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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