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: June 21, 2013
Last verified: May 2013

February 24, 2009
June 21, 2013
February 2009
April 2011   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) Rate at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
PFS rate at 12 months was defined as the percentage of patients alive without disease progression at 12 months after randomization. The primary efficacy analysis was based on assessment by the Independent Review Committee (IRC). The study was not powered for comparison of PFS rate at 12 months between the two arms (non-comparative, open-label study). Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.
Progression Free Survival rate (PFS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00851084 on ClinicalTrials.gov Archive Site
  • Progression Free Survival (PFS) [ Time Frame: From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months) ] [ Designated as safety issue: No ]

    PFS was defined as the time from the date of randomization to the date of tumor progression or death from any cause, whichever occurred first. PFS was based on tumor assessment by the Independent Review Committee (IRC). PFS was estimated from Kaplan-Meier Curves.

    The study was not powered for comparison of PFS between the two arms (non-comparative, open-label study).

    Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.

  • Overall Objective Response Rate (ORR) [ Time Frame: From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months) ] [ Designated as safety issue: No ]

    Summary of overall objective response rate based on tumor assessment by the Independent Review Committee (IRC) as per Response Evaluation Criteria in Solid Tumours (RECIST) criteria. ORR was defined as the proportion of patients with confirmed Complete Response (CR) or confirmed Partial Response (PR) relative to the total number of patients in the analysis population.

    Per RECIST v 1.0 target lesions evaluation and assessed by tumor imaging: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

    The study was not powered for comparison of ORR between the two arms (non-comparative, open-label study).

  • Overall Survival (OS) [ Time Frame: From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months) ] [ Designated as safety issue: No ]

    Overall survival was defined as the time from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earliest between the last date the patient was known to be alive and the study cutoff date.

    The study was not powered for comparison of OS between the two arms (non-comparative, open-label study).

  • Number of Participants With Treatment-emergent Adverse Events (TEAE) [ Time Frame: From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized ] [ Designated as safety issue: Yes ]
    Summary of treatment-emergent adverse events in the safety population. The National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 3.0 was used in this study to grade the severity of AEs.
  • Immunogenicity of Intravenous (IV) Aflibercept [ Time Frame: Any time post baseline and 90 days after the last infusion of aflibercept, according to baseline status ] [ Designated as safety issue: No ]
    The antidrug antibody (ADA) assay was evaluated for participants receiving aflibercept.
  • 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 ]
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 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.

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
    administration: IV infusion
    Other Names:
    • ZALTRAP™
    • AVE0005
  • Drug: oxaliplatin
    administration: IV infusion
  • Drug: 5-FU
    administration: IV infusion
  • Drug: Folinic Acid
    administration: IV infusion
  • Active Comparator: mFOLFOX6 only
    modified FOLFOX6 chemotherapy regimen
    Interventions:
    • Drug: oxaliplatin
    • Drug: 5-FU
    • Drug: Folinic Acid
  • Experimental: mFOLFOX6 + aflibercept
    modified FOLFOX6 chemotherapy regimen in combination with aflibercept
    Interventions:
    • Drug: aflibercept
    • 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
April 2011   (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
May 2013

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