ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00561470

Public ClinicalTrials.gov record NCT00561470. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Apr 29, 2026, 8:49 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID
NCT00561470
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
1,226 participants

Conditions and interventions

Interventions

  • Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) Drug
  • FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2007
Primary completion
Jan 31, 2011
Completion
May 31, 2012
Last update posted
Sep 27, 2012

2007 – 2012

United States locations

U.S. sites
87
U.S. states
26
U.S. cities
71
Facility City State ZIP Site status
Sanofi-Aventis Investigational Site Number 840119 Birmingham Alabama 35203
Sanofi-Aventis Investigational Site Number 840074 Muscle Shoals Alabama 35661
Sanofi-Aventis Investigational Site Number 840093 Hot Springs Arizona 71913
Sanofi-Aventis Investigational Site Number 840080 Anaheim California 92801
Sanofi-Aventis Investigational Site Number 840076 Fountain Valley California 92708
Sanofi-Aventis Investigational Site Number 840120 Fountain Valley California 92708
Sanofi-Aventis Investigational Site Number 840073 Greenbrae California 94904-2007
Sanofi-Aventis Investigational Site Number 840101 Hayward California 94545
Sanofi-Aventis Investigational Site Number 840046 La Jolla California 92037
Sanofi-Aventis Investigational Site Number 840116 Loma Linda California 92354
Sanofi-Aventis Investigational Site Number 840048 Long Beach California 90813
Sanofi-Aventis Investigational Site Number 840201 Oakland California 94611
Sanofi-Aventis Investigational Site Number 840901 Roseville California 95678
Sanofi-Aventis Investigational Site Number 840042 Sacramento California 95816
Sanofi-Aventis Investigational Site Number 840301 Sacramento California 95825
Sanofi-Aventis Investigational Site Number 840112 Salinas California 93901-3906
Sanofi-Aventis Investigational Site Number 840006 San Diego California 92102
Sanofi-Aventis Investigational Site Number 840106 San Diego California 92102
Sanofi-Aventis Investigational Site Number 840206 San Diego California 92102
Sanofi-Aventis Investigational Site Number 840306 San Diego California 92102
Sanofi-Aventis Investigational Site Number 840406 San Diego California 92102
Sanofi-Aventis Investigational Site Number 840506 San Diego California 92102
Sanofi-Aventis Investigational Site Number 840606 San Diego California 92102
Sanofi-Aventis Investigational Site Number 840706 San Diego California 92102
Sanofi-Aventis Investigational Site Number 840806 San Diego California 92102
Sanofi-Aventis Investigational Site Number 840906 San Diego California 92102
Sanofi-Aventis Investigational Site Number 840401 San Francisco California 94115
Sanofi-Aventis Investigational Site Number 840601 San Jose California 95119
Sanofi-Aventis Investigational Site Number 840501 Santa Clara California 95051
Sanofi-Aventis Investigational Site Number 840801 South San Francisco California 94080
Sanofi-Aventis Investigational Site Number 840001 Vallejo California 94589
Sanofi-Aventis Investigational Site Number 840701 Walnut Creek California 94596
Sanofi-Aventis Investigational Site Number 840071 Stamford Connecticut 06902
Sanofi-Aventis Investigational Site Number 840014 Newark Delaware 19718
Sanofi-Aventis Investigational Site Number 840089 Boynton Beach Florida 33435
Sanofi-Aventis Investigational Site Number 840041 Gainesville Florida 32608
Sanofi-Aventis Investigational Site Number 840031 Gainesville Florida 32610
Sanofi-Aventis Investigational Site Number 840122 Miami Florida 33176
Sanofi-Aventis Investigational Site Number 840079 The Villages Florida 32159
Sanofi-Aventis Investigational Site Number 840087 Chicago Illinois 60616
Sanofi-Aventis Investigational Site Number 840019 Decatur Illinois 62526
Sanofi-Aventis Investigational Site Number 840115 Elk Grove Village Illinois 60007
Sanofi-Aventis Investigational Site Number 840010 Naperville Illinois 60540
Sanofi-Aventis Investigational Site Number 840113 Quincy Illinois 62301
Sanofi-Aventis Investigational Site Number 840072 Indianapolis Indiana 46254
Sanofi-Aventis Investigational Site Number 840047 Indianapolis Indiana 46260
Sanofi-Aventis Investigational Site Number 840034 Munster Indiana 46321
Sanofi-Aventis Investigational Site Number 840088 Louisville Kentucky 40202
Sanofi-Aventis Investigational Site Number 840096 Paducah Kentucky 42003
Sanofi-Aventis Investigational Site Number 840043 Baton Rouge Louisiana 70809
Sanofi-Aventis Investigational Site Number 840084 Metairie Louisiana 70006
Sanofi-Aventis Investigational Site Number 840015 New Orleans Louisiana 70121
Sanofi-Aventis Investigational Site Number 840070 Rockville Maryland 20850
Sanofi-Aventis Investigational Site Number 840029 Salisbury Maryland 21801
Sanofi-Aventis Investigational Site Number 840053 Pontiac Michigan 48341
Sanofi-Aventis Investigational Site Number 840021 Saint Louis Park Minnesota 55416
Sanofi-Aventis Investigational Site Number 840081 Kansas City Missouri 64128
Sanofi-Aventis Investigational Site Number 840052 St Louis Missouri 63104
Sanofi-Aventis Investigational Site Number 840114 St Louis Missouri 63136
Sanofi-Aventis Investigational Site Number 840049 Las Vegas Nevada 89106
Sanofi-Aventis Investigational Site Number 840044 Albuquerque New Mexico 87131
Sanofi-Aventis Investigational Site Number 840036 Albany New York 12206
Sanofi-Aventis Investigational Site Number 840094 Lake Success New York 11042
Sanofi-Aventis Investigational Site Number 840017 Syracuse New York 13210
Sanofi-Aventis Investigational Site Number 840097 Syracuse New York 13210
Sanofi-Aventis Investigational Site Number 840035 Burlington North Carolina 27215
Sanofi-Aventis Investigational Site Number 840024 Charlotte North Carolina 28204
Sanofi-Aventis Investigational Site Number 840026 Charlotte North Carolina 28262
Sanofi-Aventis Investigational Site Number 840005 Goldsboro North Carolina 27534
Sanofi-Aventis Investigational Site Number 840004 Hendersonville North Carolina 28791
Sanofi-Aventis Investigational Site Number 840075 Winston-Salem North Carolina 27103
Sanofi-Aventis Investigational Site Number 840098 Cincinnati Ohio 45219
Sanofi-Aventis Investigational Site Number 840011 Kettering Ohio 45429
Sanofi-Aventis Investigational Site Number 840086 Middletown Ohio 45042
Sanofi-Aventis Investigational Site Number 840008 Toledo Ohio 43623
Sanofi-Aventis Investigational Site Number 840039 Portland Oregon 97227
Sanofi-Aventis Investigational Site Number 840118 Bethlehem Pennsylvania 18015
Sanofi-Aventis Investigational Site Number 840033 Philadelphia Pennsylvania 19107
Sanofi-Aventis Investigational Site Number 840012 Pittsburgh Pennsylvania 15212
Sanofi-Aventis Investigational Site Number 840082 Pawtucket Rhode Island 02860
Sanofi-Aventis Investigational Site Number 840095 Woonsocket Rhode Island 02895
Sanofi-Aventis Investigational Site Number 840085 Charleston South Carolina 29403
Sanofi-Aventis Investigational Site Number 840037 Spartanburg South Carolina 29303
Sanofi-Aventis Investigational Site Number 840078 Corpus Christi Texas 78405
Sanofi-Aventis Investigational Site Number 840117 Temple Texas 76508
Sanofi-Aventis Investigational Site Number 840099 Seattle Washington 98115
Sanofi-Aventis Investigational Site Number 840002 Marshfield Wisconsin 54449

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 134 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00561470, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 27, 2012 · Synced Apr 29, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00561470 live on ClinicalTrials.gov.

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