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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| irinotecan dose based on genetic polymorphism of UGT1A1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| severe toxicity (according to NCI-CTC cotation) and response with adapted dose of irinotecan | during the treatment (an expected average of 7 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Study of the blood concentration (pharmacokinetic) of irinotecan, the SN38 and SN38-G, and bevacizumab | during the first 24 hours of the first cure | |
| evaluation of treatment efficacy (progression-free survival, duration of response) | to progression (1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hervé DEVAUD, MD | Centre Jean Perrin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de la Châtaigneraie | Beaumont | 63110 | France | |||
| Centre Jean Perrin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37932443 | Derived | Ginzac 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. |
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| Clermont-Ferrand |
| 63011 |
| France |
| CHU Estaing | Clermont-Ferrand | 63011 | France |
| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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