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

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.

Conditions

• Colorectal Neoplasms
• Neoplasm Metastasis

Interventions

DRUG

Placebo

4 mg/kg of sterile aqueous buffered vehicle (pH 6.0) was administered intra venously (IV) over 1 hour on Day 1, every 2 weeks

DRUG

Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

4 mg/kg of Aflibercept was administered IV over 1 hour on Day 1, every 2 weeks.

DRUG

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

The FOLFIRI regimen was initiated immediately after Placebo administration on Day 1 The FOLFIRI regimen included: * 180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by: * 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by: * 5-FU 2400 mg/m² continuous IV infusion over 46-hours

DRUG

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

The FOLFIRI regimen was initiated immediately after Aflibercept administration on Day 1 The FOLFIRI regimen included: * 180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by: * 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by: * 5-FU 2400 mg/m² continuous IV infusion over 46-hours

Sponsors & Collaborators

• Regeneron Pharmaceuticals

  collaborator INDUSTRY

• NSABP Foundation Inc

  collaborator NETWORK

• Sanofi

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-11-30

Primary Completion

2011-02-28

Completion

2012-06-30

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Brazil
• Chile
• Czechia
• Denmark
• Estonia
• France
• Germany
• Greece
• Italy
• Netherlands
• New Zealand
• Norway
• Poland
• Puerto Rico
• Romania
• Russia
• South Africa
• South Korea
• Spain
• Sweden
• Turkey (Türkiye)
• Ukraine
• United Kingdom

Study Locations