Phase II Study of Cetuximab as Monotherapy and First Line Treatment in Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin Expressing EGFR.
Patients with locally advanced or metastatic squamous cell carcinoma (SCC) of the skin are
often bad responders to conventional chemotherapy included cisplatin.
The investigation of the EGFR expression may allow identifying new molecular targets for
novel therapeutic strategies in patients with locally advanced or metastatic SCC of the
Several publications in the literature for primary lesions and one publication for
metastatic lesions showed that EGFR was expressed in 80-90% of SCC of the skin.
Immunohistochemistry studies performed at the Gustave Roussy Institute confirm these data:
they found an over-expression of EGFR in 90% of patients with metastatic disease. These
results are in favor of the investigation of cetuximab in patients with locally advanced or
metastatic SCC of the skin expressing EGFR.
Cetuximab is a monoclonal antibody targeted against EGFR administered weekly by intravenous
route; it may be prescribed as out hospital to patients with locally advanced or metastatic
SCC of the skin expressing EGFR.
Due to the low occurrence of locally advanced or metastatic SCC of the skin, a multicenter
trial will be required.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease control rate assessed by CT or MRI
Eve Maubec, MD
Dermatology Department, Hospital Bichat, Paris, France
France: Ministry of Health