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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01292356
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : April 5, 2017
Information provided by:
Poitiers University Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Metastatic Colon Cancer Drug: cetuximab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : December 20, 2010
Actual Primary Completion Date : March 3, 2016
Actual Study Completion Date : March 3, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: cetuximab Drug: cetuximab

Primary Outcome Measures :
  1. Main criteria is the variation of skin pro-inflammatory cytokines in pre and post-therapeutic punch skin biopsies

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01292356

Chu de Poitiers
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital

Responsible Party: Docteur David TOUGERON, CHU DE POITIERS Identifier: NCT01292356     History of Changes
Other Study ID Numbers: CUTACETUX 2010-0198378-85
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Antineoplastic Agents