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

Metastatic Colon Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292356
• Other study ID #: CUTACETUX 2010-0198378-85
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2011
• Last updated: April 4, 2017
• Start date: December 20, 2010
• Est. completion date: March 3, 2016

Study information

• Verified date: April 2017
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 3, 2016
• Est. primary completion date: March 3, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Colon Cancer

Intervention

Drug:
• cetuximab

Locations

Country	Name	City	State
France	Chu de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main criteria is the variation of skin pro-inflammatory cytokines in pre and post-therapeutic punch skin biopsies