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

Sponsor
Sanofi
Study ID
NCT00851084
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • aflibercept — DRUG
    administration: IV infusion
  • oxaliplatin — DRUG
    administration: IV infusion
  • 5-FU — DRUG
    administration: IV infusion
  • Folinic Acid — DRUG
    administration: IV infusion

Study Details

The primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study. Secondary objectives include the evaluation of overall objective response rate to treatment, progression-free survival, overall survival, safety and documentation of potential immunogenicity of aflibercept. This study was a non-comparative randomized trial and was not powered for a comparison of any of the efficacy endpoints. Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a check on the similarity of the current patients to the historical controls with respect to clinical outcome when given FOLFOX6 treatment.

Key Dates

Start date
Feb 28, 2009
Status verified
May 2016
Primary completion
Apr 30, 2011
Completion
Jan 31, 2012

Study Design

Enrollment
268 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: mFOLFOX6 only
    modified FOLFOX6 chemotherapy regimen
  • Experimental: mFOLFOX6 + aflibercept
    modified FOLFOX6 chemotherapy regimen in combination with aflibercept

Primary Outcome Measure

Progression Free Survival (PFS) Rate at 12 Months [ Time Frame: 12 months ]

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