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

Completed · Phase 3 · Has a placebo group

Conditions studied: Colorectal Neoplasms, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT00561470

Run by

Sanofi

People needed

1226

Starts

2007-11-01

Expected to finish

2012-06-01

Last updated by the study team

2012-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis Investigational Site Number 840074 — Muscle Shoals, Alabama, United States
• Sanofi-Aventis Investigational Site Number 840093 — Hot Springs, Arizona, United States
• Sanofi-Aventis Investigational Site Number 840080 — Anaheim, California, United States
• Sanofi-Aventis Investigational Site Number 840076 — Fountain Valley, California, United States
• Sanofi-Aventis Investigational Site Number 840120 — Fountain Valley, California, United States
• Sanofi-Aventis Investigational Site Number 840073 — Greenbrae, California, United States
• Sanofi-Aventis Investigational Site Number 840101 — Hayward, California, United States
• Sanofi-Aventis Investigational Site Number 840046 — La Jolla, California, United States
• Sanofi-Aventis Investigational Site Number 840116 — Loma Linda, California, United States
• Sanofi-Aventis Investigational Site Number 840048 — Long Beach, California, United States
• Sanofi-Aventis Investigational Site Number 840201 — Oakland, California, United States
• Sanofi-Aventis Investigational Site Number 840901 — Roseville, California, United States
• Sanofi-Aventis Investigational Site Number 840042 — Sacramento, California, United States
• Sanofi-Aventis Investigational Site Number 840301 — Sacramento, California, United States
• Sanofi-Aventis Investigational Site Number 840112 — Salinas, California, United States
• Sanofi-Aventis Investigational Site Number 840006 — San Diego, California, United States
• Sanofi-Aventis Investigational Site Number 840106 — San Diego, California, United States
• Sanofi-Aventis Investigational Site Number 840206 — San Diego, California, United States
• Sanofi-Aventis Investigational Site Number 840306 — San Diego, California, United States
• Sanofi-Aventis Investigational Site Number 840406 — San Diego, California, United States
• Sanofi-Aventis Investigational Site Number 840506 — San Diego, California, United States
• Sanofi-Aventis Investigational Site Number 840606 — San Diego, California, United States
• Sanofi-Aventis Investigational Site Number 840706 — San Diego, California, United States
• Sanofi-Aventis Investigational Site Number 840806 — San Diego, California, United States
• Sanofi-Aventis Investigational Site Number 840119 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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