Study of Skin Toxicity of Cetuximab: Find a Link Between Skin Inflammation and Tumor Response

April 4, 2017 updated by: Poitiers University Hospital

Colon cancer is one of the most common cancers in France with more than 36,000 new cases per year. Despite significant advances in therapeutic care, the prognosis of colon cancers with metastases remains bad. The treatment of metastatic disease is based on chemotherapy coupled with therapeutic antibodies. The most commonly used are anti-EGFR (Epidermal Growth Factor Receptor), which allowed a significant increase in patient survival. They are responsible for skin toxicity in the form of an acneiform rash which can be debilitating for patients and require discontinuation of treatment. However, this toxicity is strongly correlated with treatment efficacy. Understanding the mechanisms of cutaneous side effects of anti-EGFR is therefore a major challenge to treat and better understand the association with treatment efficacy.

The objective of this study is to investigate a link between cutaneous inflammatory response in patients treated with anti-EGFR, serum level of anti-EGFR and treatment efficacy. It will be conducted systematic consultations dermatology, skin biopsies and blood samples in patients treated with anti-EGFR. From biopsies, it will be searched by an infiltration of inflammatory cells and expression of genes involved in skin inflammation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

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
      • Poitiers, France, 86021
        • CHU de Poitiers

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

Description

Inclusion Criteria:

  • Patients older than 18 years
  • Patient with histologically proven metastatic colorectal cancer with KRAS wild-type
  • Treatment with cetuximab in first line chemotherapy combined with FOLFOX or FOLFIRI
  • Patient has signed informed consent
  • Patient affiliated to the Social Security
  • Prescription of cetuximab in agreement with the Summary of Product Characteristics

Exclusion Criteria:

  • Patients aged under 18
  • Patients taking immunosuppressive therapy
  • Patient having a severe skin disease
  • No measurable metastasis
  • Patients with a contra-indication of cetuximab: hypersensitivity to cetuximab or to any excipients
  • Severe alteration of respiratory or cardiac function or severe coronary disease
  • Patients with contra-indication to chemotherapy FOLFOX and FOLFIRI
  • Participation in another research protocol
  • Patients not affiliated to the Social Security
  • Hospitalized patients without consent
  • Pregnant or nursing women, women of childbearing age with no effective contraception

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?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cetuximab
Drug: cetuximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Main criteria is the variation of skin pro-inflammatory cytokines in pre and post-therapeutic punch skin biopsies

Collaborators and Investigators

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

Sponsor

Poitiers University Hospital

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 (Actual)

December 20, 2010

Primary Completion (Actual)

March 3, 2016

Study Completion (Actual)

March 3, 2016

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 8, 2011

First Posted (Estimate)

February 9, 2011

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUTACETUX 2010-0198378-85

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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