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
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.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00561470
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,226 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) Drug
- FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) 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
- Nov 2007 (Type not available)
- Primary completion
- Feb 2011 (Actual)
- Completion
- Jun 2012 (Actual)
- Last update posted
- Sep 28, 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 28, 2012 · Synced Nov 9, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00561470 live on ClinicalTrials.gov.