Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR

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.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Histological SCC of the skin expressing (IHC) moderately or highly the EGFR (++ and +++, on a semi-quantitative scale).
* Locally advanced or metastatic SCC of the skin not suitable for local surgery with documented progression.
* Presence of at least one measurable target lesion by RECIST criteria.
* At least one lesion accessible to biopsies.
* ECOG Performance status \< 2.
* Life expectancy \> 3 months.
* Age \> 18 years.
* Normal hematological (Neutrophils \> 1.5x109 cells/l, platelets \> 100x109 cells/l), hepatic (bilirubin \< 1.5 times the upper limit of the normal range (ULN); alkaline phosphatase and transaminases \< 5 x UNL in case of hepatic metastases or \< 2.5 x UNL in absence of hepatic metastases) and renal (serum creatinine \< 150 micromol/L) functions.
* Written informed consent.
* In case of second tumor,excepted carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma, the possibility for including a patient may be discussed with the principal investigator.

Exclusion Criteria:

* Prior chemotherapy
* Prior radiotherapy \< 1 month.
* Prior therapy with agent targeting EGFR
* Unstable systemic diseases or active uncontrolled infections.
* Patients (male and female) not using effective contraception if of reproductive potential.
* Females pregnant or lactating. Women of child bearing potential must have a negative serum or urine pregnancy test prior to start each cycle of treatment.

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• BACKGROUNDNemunaitis JJ, Eiseman I, Cunningham C et al. A phase I trial of CI-1033, a pan-erbB tyrosine kinase inhibitor, given daily for 14 days every 3 weeks, in patients with advanced solid tumors. Proc Am Soc Clin Oncol 22: page 243, 2003 (abstr 974).
• RESULTMaubec E, Petrow P, Scheer-Senyarich I, Duvillard P, Lacroix L, Gelly J, Certain A, Duval X, Crickx B, Buffard V, Basset-Seguin N, Saez P, Duval-Modeste AB, Adamski H, Mansard S, Grange F, Dompmartin A, Faivre S, Mentre F, Avril MF. Phase II study of cetuximab as first-line single-drug therapy in patients with unresectable squamous cell carcinoma of the skin. J Clin Oncol. 2011 Sep 1;29(25):3419-26. doi: 10.1200/JCO.2010.34.1735. Epub 2011 Aug 1.