NCT02181556

Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Federation Francophone de Cancerologie Digestive · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

One of the treatments generally used to treat this disease is a chemotherapy called FOLFIRI. The purpose of this study is to improve the efficacy of the chemotherapy by adding a protein, similar to immunoglobulins, aflibercept, and to assess their tolerance. Aflibercept is a protein that has already been studied in the treatment of metastatic colorectal cancers, in combination with a chemotherapy involving irinotecan in addition to 5FU (fluoropyrimidine) ( (FOLFIRI) as 2nd line treatment. It is marketed in Europe and it is authorized in the United States. Its addition to this chemotherapy combination has in fact brought about a benefit in terms of progression-free survival and overall survival. The purpose of the study is to evaluate the efficacy and tolerance of this combination rather in the initial approach to the treatment of metastatic colorectal cancers and hence to evaluate it as 1st line treatment

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	FOLFIRI Protocol	injection of FOLFIRI and Aflibercept every 14 days until progression of disease
DRUG	Aflibercept Injection	injection of FOLFIRI and Aflibercept every 14 days until progression of disease

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-02-01
• Completion: 2017-07-01
• First posted: 2014-07-04
• Last updated: 2021-06-07
• Results posted: 2021-06-07

Locations

8 sites across 1 country: France