1,226
Participants
Start Date
November 30, 2007
Primary Completion Date
February 28, 2011
Study Completion Date
June 30, 2012
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
Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
4 mg/kg of Aflibercept was administered IV over 1 hour on Day 1, every 2 weeks.
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"
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"
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Sanofi-Aventis Investigational Site Number 300002, Ilion, Athens
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Lead Sponsor
Regeneron Pharmaceuticals
INDUSTRY
NSABP Foundation Inc
NETWORK
Sanofi
INDUSTRY