Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer
- Sponsor
- Centre Jean Perrin
- Study ID
- NCT01963182
- Phase
- PHASE2
- Status
- Completed
Conditions
- First Line Metastatic Colorectal Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Irinotecan — DRUG
Study Details
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.
Key Dates
- Start date
- Oct 31, 2013
- Status verified
- Dec 2019
- Primary completion
- Dec 31, 2019
- Completion
- Dec 9, 2019
Study Design
- Enrollment
- 47 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: irinotecan dose based on genetic polymorphism of UGT1A1
Primary Outcome Measure
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) ]