Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen — VELOUR  

Colorectal Neoplasms Clinical Trial

Official title: A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan / 5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen

Status Completed

Clinical Trial Summary

The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease.

The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.

Clinical Trial Description

Participants were

• randomized at baseline (treatment was initiated with 3 days of randomization)

• administered treatment in cycles of 14-days till a study withdrawal criterion was met

• followed up 30 days after discontinuation of treatment, and every 8 weeks until death or end of study.

The criteria for discontinuation of study treatment for a participant are:

• participant (or legal representative) chose to withdraw from treatment

• the investigator thought that continuation of the study would be detrimental to the participants well-being due to

• disease progression

• unacceptable AEs

• intercurrent illnesses

• non-compliance to the study protocol

• participant was lost to follow-up

• participant was unblinded for the investigational treatment ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Neoplasm Metastasis
• Neoplasms

• NCT number: NCT00561470
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: November 2007
• Completion date: June 2012