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Evaluation of the Efficacy and the Safety of FOLFIRINOX3 Bevacizumab Treatment in Patients With Colorectal Cancer (FOLFIRINOX 3)
Sponsor: Centre Georges Francois Leclerc
Summary
In patients in progression after oxaliplatin and irinotecan, the study FOLFIRINOX 3 proposes to evaluate the interest of modifying the standard pattern of administration of the molecule of irinotecan in order to make it more efficient. In combination with other chemotherapy drugs (5-fluorouracil, oxaliplatin, folinic acid and bevacizumab), irinotecan will be administered at the beginning and end of each cycle of chemotherapy, whereas it is normally administered at one time in the regimen. standard of treatment. The hypothesis of this study is an increase in the objective response rate at 2 months of 10 to 30% with a scheme by FOLFIRINOX3 - bevacizumab compared to an optimal treatment to date by FOLFIRINOX-bevacizumab.
Official title: Phase I / II Study Evaluating the Efficacy and Safety of FOLFIRINOX3 Bevacizumab Treatment in Patients With Colorectal Cancer Who Have Failed With Standard Chemotherapy Protocols (FOLFIRINOX 3)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2018-11-07
Completion Date
2025-07-16
Last Updated
2025-02-17
Healthy Volunteers
No
Conditions
Interventions
FOLFIRINOX Bevacizumab
In phase 1, the goal is to define the DLT (maximum tolerated dose). 3 levels of doses will be evaluated with a different dose of irinotecan in each level. * Level -1: Bevacizumab + Oxaliplatine + Acide folinique + Irinotecan: 60mg / m2 * Level 0: Bevacizumab + Oxaliplatine + Acide folinique +Irinotecan: 70mg / m2 * Level 1: Bevacizumab + Oxaliplatine + Acide folinique +Irinotecan: 90mg / m2 The inclusion of patients will start at level 0. Dose-limiting toxicities will be identified during the first 2 cycles.
Locations (1)
Centre Georges François Leclerc
Dijon, France