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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Poitiers University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01292356
First received: February 7, 2011
Last updated: July 9, 2012
Last verified: May 2011
History of Changes
  Purpose

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 Intervention Phase
Metastatic Colon Cancer
 Drug: cetuximab
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Cetuximab
U.S. FDA Resources

Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:
  • Main criteria is the variation of skin pro-inflammatory cytokines in pre and post-therapeutic punch skin biopsies [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: December 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cetuximab Drug: cetuximab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292356

Contacts
Contact: David TOUGERON, MD • + (33) 5.49.44.37.51 david.tougeron@chu-poitiers.fr

Locations
France
Chu de Poitiers Recruiting
Poitiers, France, 86021
Principal Investigator: David TOUGERON, MD            
Sponsors and Collaborators
Poitiers University Hospital
  More Information

No publications provided

Responsible Party: Docteur David TOUGERON, CHU DE POITIERS
ClinicalTrials.gov Identifier: NCT01292356     History of Changes
Other Study ID Numbers: CUTACETUX 2010-0198378-85
Study First Received: February 7, 2011
Last Updated: July 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013