Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer (AFFIRM)


Tracking Information

Start Date  ICMJEFebruary 2009
Estimated Primary Completion DateSeptember 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: February 24, 2009)		Progression Free Survival rate (PFS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00851084 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: February 24, 2009)
  • Overall Response rate (ORR) [ Time Frame: measured every 8 weeks up to disease progression ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) [ Time Frame: Study period ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Study period ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
Official Title  ICMJERandomized, Multinational, Study Of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
Brief Summary

The main objective of the study is to estimate the percentage of patients without progression of the disease at 12 months.

Secondary objectives include the evaluation of response to treatment, overall survival, safety and documentation of potential immunogenicity of aflibercept.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Condition  ICMJE
  • Colorectal Neoplasms
  • Neoplasm Metastasis
Intervention  ICMJE
  • Drug: aflibercept (AVE0005)
    administration: IV infusion
  • Drug: oxaliplatin
    administration: IV infusion
  • Drug: 5-FU
    administration: IV infusion
  • Drug: Folinic Acid
    administration: IV infusion
Study Arms / Comparison Groups
  • A: Active Comparator
    modified FOLFOX6
    Interventions:
    • Drug: oxaliplatin
    • Drug: 5-FU
    • Drug: Folinic Acid
  • B: Experimental
    modified FOLFOX6 in combination with aflibercept
    Interventions:
    • Drug: aflibercept (AVE0005)
    • Drug: oxaliplatin
    • Drug: 5-FU
    • Drug: Folinic Acid

Recruitment Information

Estimated Enrollment  ICMJE230
Estimated Completion DateSeptember 2011
Estimated Primary Completion DateSeptember 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven adenocarcinoma of the colon or the rectum
  • Metastatic disease not amenable to potentially curative treatment

Exclusion Criteria:

  • Prior therapy for metastatic cancer of the colon or the rectum
  • Prior treatment with angiogenesis inhibitors

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  ICMJEAustralia,   Germany,   Italy,   Korea, Republic of,   Russian Federation,   Spain,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00851084
Responsible PartyICD Study Director, sanofi-aventis
Study ID Numbers  ICMJEEFC10668, EudraCT 2008-004178-41
Study Sponsor  ICMJESanofi-Aventis
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:John Zalcberg, MDPeter Mc Callum Cancer Centre, Melbourne, Australia
Information Provided BySanofi-Aventis