Clinical trial · Interventional
Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer
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
NCT01963182CI-TRIAL-00042480IriGencompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| First Line Metastatic Colorectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- irinotecan dose based on genetic polymorphism of UGT1A1
- interventionNames
- Drug: Irinotecan
Primary outcomes (1)
- measure
- severe toxicity (according to NCI-CTC cotation) and response with adapted dose of irinotecan
- timeFrame
- during the treatment (an expected average of 7 months)
Secondary outcomes (2)
- measure
- Study of the blood concentration (pharmacokinetic) of irinotecan, the SN38 and SN38-G, and bevacizumab
- timeFrame
- during the first 24 hours of the first cure
- measure
- evaluation of treatment efficacy (progression-free survival, duration of response)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGinzac 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. PMID 37932443