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Completed

NCT Number: NCT00851084

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Colonic Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Investigational Site Number 036004, Douglas, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

aflibercept

Drug

administration: IV infusion

Other names: ZALTRAP™, AVE0005

Oxaliplatin

Drug

administration: IV infusion

5-FU

Drug

administration: IV infusion

Folinic acid

Drug

administration: IV infusion

Primary outcomes

  1. Progression Free Survival (PFS) Rate at 12 Months

    Time frame: 12 months

    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.

Secondary outcomes

  1. 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)

    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.

  2. 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)

    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).

  3. 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)

    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).

  4. 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

    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.

  5. Immunogenicity of Intravenous (IV) Aflibercept

    Time frame: Any time post baseline and 90 days after the last infusion of aflibercept, according to baseline status

    The antidrug antibody (ADA) assay was evaluated for participants receiving aflibercept.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Randomized, Multinational, Study Of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer

Acronym: AFFIRM

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Feb 25, 2009
Registry last updated
Jun 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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