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
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: First Line Metastatic Colorectal Cancer
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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:
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)
timeFrame: to progression (1 year)
Other outcomes:
Locations:
city: Beaumont
country: France
facility: Clinique de la Châtaigneraie
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Clermont-Ferrand
country: France
facility: CHU Estaing
Study officials:
affiliation: Centre Jean Perrin
name: Hervé DEVAUD, MD
role: PRINCIPAL_INVESTIGATOR
References: