CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
FOLFIRI Protocol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02181556
NCT02181556Phase 2Completed

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

Federation Francophone de Cancerologie Digestive·interventional·Posted Jul 4, 2014·Updated Jun 7, 2021

In Brief

A Phase 2 clinical trial evaluating FOLFIRI Protocol and Aflibercept Injection for Metastatic Colorectal Cancer. Completed, enrolled 41 participants across 8 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 4, 2014
Enrollment StartOct 1, 2014
Primary CompletionFeb 1, 2017
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.0 years ago

Interventions

FOLFIRI Protocoldrug

injection of FOLFIRI and Aflibercept every 14 days until progression of disease

Aflibercept Injectiondrug

injection of FOLFIRI and Aflibercept every 14 days until progression of disease