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

Poitiers University Hospital

Status and phase

Completed

Phase 2

Conditions

Metastatic Colon Cancer

Treatments

Drug: cetuximab

Study type

Interventional

Funder types

Other

Identifiers

NCT01292356

CUTACETUX 2010-0198378-85

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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