The purpose of this study is to determine whether cetuximab is effective in the treatment of 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 skin. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Dosage form: bottles of 50 ml, 2 mg/ml; Dosage:400 mg/m2 initial dose followed by 250 mg/m2 by infusion every week; Number of Cycles : until progression or unacceptable toxicity develops.
Hospital of Caen
Caen, France
Hospital of Chartres
Chartres, France
Hospital Hôtel Dieu
Clermont-Ferrand, France
Disease control rate assessed by CT or MRI
Time frame: 6 weeks
Safety profile.
Time frame: during treatment or within 30 days after the final administration with a cut-off date at week 48.
Time to disease progression.
Time frame: number of days from the start of treatment to the earliest day of progressive disease
Overall survival.
Time frame: from the first infusion until week 48 or death
Duration of response in responder patients at 6 weeks.
Time frame: time to disease progression
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Beaujon's Hospital
Clichy, France
CHR of Colmar
Colmar, France
Hospital Henri Mondor
Créteil, France
Hospital Tarnier-Cochin
Paris, France
Hospital Saint Louis, Department of P. Morel
Paris, France
Hospital Saint-Louis, department of L. Dubertret
Paris, France
Hospital Bichat
Paris, France
...and 4 more locations