Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in theTreatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen (VELOUR)


Tracking Information

Start Date  ICMJENovember 2007
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: August 21, 2008)		Overall Survival [ Time Frame: Study period ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: November 20, 2007)		Overall Survival
Change HistoryComplete list of historical versions of study NCT00561470 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: August 21, 2008)
  • Progression Free Survival [ Time Frame: Study period ] [ Designated as safety issue: No ]
  • Tumor Response Rate [ Time Frame: every 6 weeks up to disease progression ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: every 2 weeks while on treatment ] [ Designated as safety issue: Yes ]
  • Immunogenicity [ Time Frame: up to 90 days post last dose of study drug ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: November 20, 2007)
  • Progression Free Survival
  • Tumor Response Rate [ Time Frame: every 6 weeks up to disease progression ]
  • Safety [ Time Frame: every 2 weeks while on treatment ]
  • Immunogenicity [ Time Frame: up to 90 days post last dose of study drug ]

Descriptive Information

Brief Title  ICMJEAflibercept Versus Placebo in Combination With Irinotecan and 5-FU in theTreatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen
Official Title  ICMJEA 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

The main objective of the study is evaluate the effectiveness of aflibercept in increasing the overall survival in patients with metastatic colorectal cancer treated with irinotecan and 5-FU and that have previously failed an oxaliplatin based treatment for metastatic disease.

Secondary objectives include response to treatment, progression free survival, safety, documentation of potential immunogenicity of aflibercept and, in selected centers the pharmacokinetics of aflibercept.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Condition  ICMJE
  • Colorectal Neoplasms
  • Neoplasm Metastasis
Intervention  ICMJE
  • Drug: Aflibercept (AVE0005)
    Associated to FOLFIRI regimen
  • Drug: Placebo
    Associated to FOLFIRI regimen
Study Arms / Comparison Groups
  • Arm A: Experimental
    Intervention: Drug: Aflibercept (AVE0005)
  • Arm B: Placebo Comparator
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE1200
Estimated Completion DateDecember 2010
Estimated Primary Completion DateDecember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically proven adenocarcinoma of the colon or rectum
  • Metastatic disease that is not amenable to potentially curative treatment
  • One and only one prior line of treatment for metastatic disease. This prior line should be an oxaliplatin based chemotherapy (patients who relapse within 6 months of completion of oxaliplatin based adjuvant chemotherapy are eligible)

Exclusion Criteria:

  • Prior therapy with irinotecan
  • Eastern Cooperative Oncology Group performance status >2

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Public Registry ICDGV-Contact-us@sanofi-aventis.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Chile,   Czech Republic,   Denmark,   Estonia,   France,   Germany,   Greece,   Italy,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Puerto Rico,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   Turkey,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00561470
Responsible PartyICD Study Director, sanofi-aventis
Study ID Numbers  ICMJEEFC10262, EudraCT 2007-000820-42
Study Sponsor  ICMJESanofi-Aventis
Collaborators  ICMJE
  • Regeneron Pharmaceuticals
  • National Surgical Adjuvant Breast and Bowel Project (NSABP)
Investigators  ICMJE
Study Director:ICDSanofi-Aventis
Information Provided BySanofi-Aventis