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