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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 (VELOUR)

This study has been completed.
Sponsor:
Collaborators:
Regeneron Pharmaceuticals
NSABP Foundation Inc
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00561470
First received: November 20, 2007
Last updated: September 27, 2012
Last verified: March 2012
Results First Received: August 17, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Colorectal Neoplasms
Neoplasm Metastasis
Interventions: Drug: Placebo
Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo/Folfiri Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
Aflibercept/Folfiri Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
Total Total of all reporting groups

Baseline Measures
   Placebo/Folfiri   Aflibercept/Folfiri   Total 
Overall Participants Analyzed 
[Units: Participants]
 614   612   1226 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.2  (10.8)   59.5  (10.5)   59.8  (10.7) 
Age, Customized 
[Units: Participants]
     
<65 years   376   407   783 
>=65 but <75 years   199   172   371 
>=75 years   39   33   72 
Gender, Customized 
[Units: Participants]
     
Male   353   365   718 
Female   261   247   508 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian/White   523   548   1071 
Black   27   16   43 
Asian/Oriental   51   35   86 
Other   13   13   26 
Region of Enrollment 
[Units: Participants]
     
ARGENTINA   4   2   6 
AUSTRALIA   42   54   96 
AUSTRIA   3   4   7 
BELGIUM   37   45   82 
BRAZIL   21   27   48 
CHILE   31   33   64 
CZECH REPUBLIC   30   47   77 
DENMARK   9   6   15 
ESTONIA   7   3   10 
FRANCE   1   1   2 
GERMANY   23   12   35 
GREECE   9   10   19 
ITALY   26   23   49 
KOREA, REPUBLIC OF   39   26   65 
NETHERLANDS   20   14   34 
NEW ZEALAND   13   7   20 
NORWAY   14   19   33 
POLAND   24   32   56 
PUERTO RICO   4   2   6 
ROMANIA   16   16   32 
RUSSIAN FEDERATION   35   40   75 
SOUTH AFRICA   36   31   67 
SPAIN   27   28   55 
SWEDEN   10   4   14 
TURKEY   4   2   6 
UKRAINE   11   11   22 
UNITED KINGDOM   47   52   99 
UNITED STATES   71   61   132 
Eastern Cooperative Oncology Group (ECOG) performance status score [1] 
[Units: Participants]
     
Participants with ECOG Score = 0   350   349   699 
Participants with ECOG Score = 1   250   250   500 
Participants with ECOG Score = 2   14   13   27 
[1] The ECOG score assesses how the disease affects a participant's daily living abilities. It ranges from 0-5, with 0 being the best and 5 being the worst outcome. "0" reflects a fully active participant, able to carry on all pre-disease performance without restriction. "1" reflects a participant restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. "2" reflects an ambulatory participant, who is up and about more than 50% of waking hours, and capable of all self-care but unable to carry out any work activities.
Prior Bevacizumab [1] 
[Units: Participants]
     
Yes   187   186   373 
No   427   426   853 
[1] Number of participants randomized in the prior bevacizumab stratum as per the interactive voice response system (IVRS).


  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years) ]

2.  Secondary:   Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)   [ Time Frame: From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months) ]

3.  Secondary:   Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria   [ Time Frame: From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months) ]

4.  Secondary:   Number of Participants With Adverse Events (AE)   [ Time Frame: From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized ]

5.  Secondary:   Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay   [ Time Frame: Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information