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

NCT01292356 | Completed Phase 2

• 1 other identifier: CUTACETUX 2010-0198378-85
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colon Cancer

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

cetuximab

EXPERIMENTAL

Drug: cetuximab

Interventions

cetuximab DRUG

cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Chu de Poitiers

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: February 9, 2011
• Study Start: December 20, 2010
• Primary Completion: March 3, 2016
• Study Completion: March 3, 2016
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

FR (1)