Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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

Eligibility Criteria

Participants who met the following main selection criteria were included in the study.

Inclusion Criteria:

• Histologically or cytologically proven adenocarcinoma of the colon or rectum

• Metastatic disease that is not amenable to potentially curative treatment

• One and only one prior line of treatment for metastatic disease. This prior line should be an oxaliplatin based chemotherapy (participants who relapse within 6 months of completion of oxaliplatin based adjuvant chemotherapy are eligible)

• Prior treatment with bevacizumab is permitted.

Exclusion Criteria:

• Prior therapy with irinotecan

• Eastern Cooperative Oncology Group performance status >2

The above information is not intended to contain all considerations relevant to participation in a clinical trial.

Trial Contact Information

Trial Lead Organizations/Sponsors

Sanofi-Aventis United Kingdom

Clinical Sciences & Operations

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00561470
Information obtained from ClinicalTrials.gov on November 22, 2012

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