Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms (FCRVADS)

April 9, 2013 updated by: Institut Bergonié

Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms in Cetuximab Activity Used in Palliative Treatment of Upper Aerodigestive Tract Tumours

Hypothesis:

Cetuximab, an anti-EGFR antibody, is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers. Actually, no predictive biomarkers of Cetuximab antitumor activity are known in this setting. It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab.

The investigators therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypothesis:

Cetuximab, an anti-EGFR antibody, is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers. Actually, no predictive biomarkers of Cetuximab antitumor activity are known in this setting. It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab.

We therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment.

This study is a multicentre prospective pharmacogenetic observational study, conducted on locally advanced and inoperable upper aerodigestive tract cancers.

Study Type

Observational

Enrollment (Actual)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33000
        • Institut Bergonie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Squamous cell carcinomas of the upper aero-digestive tract recurrent or metastatic.

Description

Inclusion Criteria:

  • Patient with recurrent or metastatic squamous cell carcinomas of the upper aero-digestive tract
  • Patient with loco-regional extension not readily treatable
  • 18 years
  • Follow up in participant center
  • Patient information and consent for study participation
  • Patient presented in multidisciplinary meeting (RCP) in Aquitaine and for whom a treatment containing cetuximab has been proposed
  • Belong to a social security system

Exclusion Criteria:

  • Pregnancy
  • Patient with psychological, social, family or geographical reason, who could not be treated or monitored regularly by study criteria,
  • Patients deprived of liberty or under guardianship or who could not give consent for study participation
  • Inclusion in another study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Blood sample
Blood sample for identifying the polymorphism
Other: Blood sample for identifying the polymorphism
Blood sample for identifying the polymorphism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The main objective is to evaluate the role of FCGR3A and FCGR2A receptor polymorphism in cetuximab and chemotherapy response, in patients with recurrent or metastatic squamous cell carcinomas of the upper aero-digestive tract
Time Frame: Proportion of patients with positive response to treatment at 4 months
The main objective is to evaluate the role of FCGR3A and FCGR2A receptor polymorphism in cetuximab and chemotherapy response, in patients with recurrent or metastatic squamous cell carcinomas of the upper aero-digestive tract
Proportion of patients with positive response to treatment at 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival Overall survival Toxicity
Time Frame: Progression-free survival: Tumour evaluation will be done at baseline and at 4 months or until the earlier of the following events: disease progression, patient death.
Overall survival: defined as the time between the first cycle of chemotherapy and the date of death, all causes. In the absence of death confirmation, survival data are censored from the date of last news
Progression-free survival: Tumour evaluation will be done at baseline and at 4 months or until the earlier of the following events: disease progression, patient death.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Investigators

  • Principal Investigator: ROBERT Jacques, PU-PH, Institut Bergonie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

April 9, 2013

First Posted (Estimate)

April 10, 2013

Study Record Updates

Last Update Posted (Estimate)

April 10, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB2009-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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