drugset / Trial / NCT03795311
Evaluation of the Efficacy and the Safety of FOLFIRINOX3 Bevacizumab Treatment in Patients With Colorectal Cancer (FOLFIRINOX 3)
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-11-07
- Primary completion
- 2023-01-16
- Completion
- 2025-07-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Irinotecan | Small molecule | 60 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 70 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 90 mg/m2 | — |
| Background | Bevacizumab | Monoclonal antibody | 5 mg/kg | — |
| Background | Leucovorin | Small molecule | 200 mg/m2 | — |
| Background | Leucovorin | Small molecule | 400 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | — |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | — |