- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01963182
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
Conditions
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
-
-
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Beaumont, France, 63110
- Clinique De La Chataigneraie
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Clermont-Ferrand, France, 63011
- Centre Jean Perrin
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Clermont-Ferrand, France, 63011
- CHU Estaing
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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
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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)
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during the treatment (an expected average of 7 months)
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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
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during the first 24 hours of the first cure
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evaluation of treatment efficacy (progression-free survival, duration of response)
Time Frame: to progression (1 year)
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to progression (1 year)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- 2013-001275-21
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.
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