Clinical trial NCT01827956: Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms
Official title: Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms in Cetuximab Activity Used in Palliative Treatment of Upper Aerodigestive Tract Tumours
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Gingival Squamous Cell Carcinoma
Keywords: Upper aero-digestive tract tumours
FCGR3A and FCGR2A receptor polymorphism
Cetuximab efficacy
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Squamous cell carcinomas of the upper aero-digestive tract recurrent or metastatic.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Proportion of patients with positive response to treatment at 4 months
Secondary outcomes:
measure: Progression-free survival Overall survival Toxicity
timeFrame: 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.
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
state: Aquitaine
Study officials:
affiliation: Institut Bergonié
name: ROBERT Jacques, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: