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ACTIVE NOT RECRUITING
NCT03795311
PHASE1/PHASE2

Evaluation of the Efficacy and the Safety of FOLFIRINOX3 Bevacizumab Treatment in Patients With Colorectal Cancer (FOLFIRINOX 3)

Sponsor: Centre Georges Francois Leclerc

View on ClinicalTrials.gov

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

Interventions

DRUG

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