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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00851084
First received: February 24, 2009
Last updated: March 1, 2012
Last verified: March 2012
History of Changes

February 24, 2009
March 1, 2012
February 2009
January 2012   (final data collection date for primary outcome measure)
Progression Free Survival rate (PFS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00851084 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
Randomized, Multinational, Study Of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Drug: aflibercept (AVE0005)
    administration: IV infusion
  • Drug: oxaliplatin
    administration: IV infusion
  • Drug: 5-FU
    administration: IV infusion
  • Drug: Folinic Acid
    administration: IV infusion
  • Active Comparator: A
    modified FOLFOX6
    Interventions:
    • Drug: oxaliplatin
    • Drug: 5-FU
    • Drug: Folinic Acid
  • Experimental: B
    modified FOLFOX6 in combination with aflibercept
    Interventions:
    • Drug: aflibercept (AVE0005)
    • Drug: oxaliplatin
    • Drug: 5-FU
    • Drug: Folinic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
268
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Germany,   Italy,   Korea, Republic of,   Russian Federation,   Spain,   United Kingdom
 
NCT00851084
EFC10668, EudraCT 2008-004178-41
Yes
Sanofi
Sanofi
Not Provided
Principal Investigator: John Zalcberg, MD Peter Mc Callum Cancer Centre, Melbourne, Australia
Sanofi
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP