NCT04534218

Regorafenib in Combination With Metronomic Chemotherapies, and Low-dose Aspirin in Metastatic Colorectal Cancer

Regorafenib in Combination With Metronomic Cyclophosphamide, Capecitabine, and Low-dose Aspirin in Metastatic Colorectal Cancer Carcinoma An Open-label Phase II

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose a phase II clinical trial with the objective to investigate the potential clinical interest to associate regorafenib with a metronomic chemotherapy combining capecitabine, cyclophosphamide and low-dose aspirin, for the treatment of patients with metastatic colorectal cancer. The main objective of the study will be to achieve 15% of objective response rate in patients treated with multimodal metronomic chemotherapy and regorafenib.

Conditions

• Colo-rectal Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Regorafenib	* For the first cycle: regorafenib will be administered according to the "REDOS" schedule (80 mg daily for week 1, 120 mg daily for week 2 and 160 mg daily for the third week of the first cycle). * For the following cycles: regorafenib will be administered at a 80, 120 or 160 mg daily dose according to toxicity observed with the last dose used in the first cycle.
DRUG	Cyclophosphamide	50 mg per os, daily, for 6 months
DRUG	Capecitabine	625mg/m²/orally twice daily continuously for 6 months
DRUG	Aspirin	75 mg orally and daily until progression

Timeline

• Start date: 2020-10-16
• Primary completion: 2023-12-13
• Completion: 2023-12-13
• First posted: 2020-09-01
• Last updated: 2024-12-20

Locations

3 sites across 1 country: France