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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001275-21-FR

Enrollment

Registered

2013-06-03

Start date

2013-07-29

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

first line metastatic colorectal cancer MedDRA version: 14.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864

Interventions

Trade Name: Irinotecan Product Name: Irinotecan Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Colorectal cancer histologically or cytologically proven - Indication of treatment according to the FOLFIRI + / - bevacizumab - Age> 18 years - Presence of at least one measurable target by RECIST - Life expectancy> 3 months - Satisfactory biological functions (renal, hepatic and hematologic) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37

Exclusion criteria

Exclusion criteria: - Patients of childbearing age and not using effective contraception 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 - Significant psychiatric or neurological abnormality - Infectious syndrome requiring treatment with antibiotics or antiviral long-term - Against Heart indication 5-FU - Concurrent treatment with a drug test, participation in a clinical trial within <30 days

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the interest in terms of toxicity and response individualizing dosage of irinotecan according polymorphism UGT1A1; Secondary Objective: -Study of the pharmacokinetics of irinotecan, the SN38 and SN38-G, and bevacizumab -Evaluation of the effectiveness of treatment (progression-free survival, duration of response) ; Primary end point(s): - The frequency of occurrence of severe toxicities of grade 4 neutropenia, febrile neutropenia, grade 4 diarrhea Toxicities will be graded according to NCI-CTC scoring, version 4.0 throughout the treatment. Toxicities are therefore identified in each course. - The response rate of patients with partial response or complete response to the number of patients (ITT). The response to treatment will be assessed according to RECIST version 1.1 criteria.	—

Measure

Time frame

Main Objective: Assess the interest in terms of toxicity and response individualizing dosage of irinotecan according polymorphism UGT1A1; Secondary Objective: -Study of the pharmacokinetics of irinotecan, the SN38 and SN38-G, and bevacizumab -Evaluation of the effectiveness of treatment (progression-free survival, duration of response) ; Primary end point(s): - The frequency of occurrence of severe toxicities of grade 4 neutropenia, febrile neutropenia, grade 4 diarrhea Toxicities will be graded according to NCI-CTC scoring, version 4.0 throughout the treatment. Toxicities are therefore identified in each course. - The response rate of patients with partial response or complete response to the number of patients (ITT). The response to treatment will be assessed according to RECIST version 1.1 criteria.

—

Secondary

Measure	Time frame
Secondary end point(s): - Pharmacokinetics of irinotecan, the SN38, the SN38-G, bevacizumab: Measurements of the plasma concentration and AUC will be made ??using a specific analysis, liquid chromatography coupled to a mass spectrometer technique. - Evaluation of overall survival and progression-free survival.	—

Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026