NCT00851084

Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer

Randomized, Multinational, Study Of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study. Secondary objectives include the evaluation of overall objective response rate to treatment, progression-free survival, overall survival, safety and documentation of potential immunogenicity of aflibercept. This study was a non-comparative randomized trial and was not powered for a comparison of any of the efficacy endpoints. Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a check on the similarity of the current patients to the historical controls with respect to clinical outcome when given FOLFOX6 treatment.

Conditions

• Colorectal Neoplasms
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	aflibercept	administration: IV infusion
DRUG	oxaliplatin	administration: IV infusion
DRUG	5-FU	administration: IV infusion
DRUG	Folinic Acid	administration: IV infusion

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-04-01
• Completion: 2012-01-01
• First posted: 2009-02-25
• Last updated: 2016-06-07
• Results posted: 2013-06-25

Locations

37 sites across 7 countries: Australia, Germany, Italy, Russia, South Korea, Spain, United Kingdom