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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over Other 2005-001098-82 NCT00240682

Trial Description

Summary

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.

Further Study Information

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.

Eligibility Criteria

Inclusion Criteria:

1. Histological SCC of the skin expressing (IHC) moderately or highly the EGFR (++ and +++, on a semi-quantitative scale).

2. Locally advanced or metastatic SCC of the skin not suitable for local surgery with documented progression.

3. Presence of at least one measurable target lesion by RECIST criteria.

4. At least one lesion accessible to biopsies.

5. ECOG Performance status < 2.

6. Life expectancy > 3 months.

7. Age > 18 years.

8. 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.

9. Written informed consent.

10. 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Hopital Louis Pasteur

Eve Maubec, MD

Principal Investigator

Eve Maubec, MD		Ph: 33140257300
		Email: eve.maubec@bch.aphp.fr

France
	Caen
	CHU de Caen
		Sixtine de Raucourt, MD	Ph: 33231272510
			Email: deraucourt-s@chu-caen.fr
		Anne Dompmartin, MD	Principal Investigator
		Sixtine de Raucourt, MD	Principal Investigator
	Chartres
	Hopital Louis Pasteur
		Pierre Saez, MD	Ph: 33237303067
			Email: psaez@ch-chartres.fr
		Pierre Saez, MD	Principal Investigator
		Eric Angellier, MD	Principal Investigator
		David Solub, MD	Principal Investigator
	Clermont-Ferrand
	CHR Clermont Ferrand, Hotel Dieu
		Sandrine Mansard, MD	Ph: 33473750555
			Email: smansard@chu-clermontferrand.fr
		Sandrine Mansard, MD	Principal Investigator
		Pierre Souteyrand, MD	Principal Investigator
	Clichy
	Hopital Beaujon
		Sandrine Faivre	Ph: 33140875617
			Email: sandrine.faivre@bjn.aphp.fr
		Sandrine Faivre, MD	Principal Investigator
		Eric Raymond, MD	Principal Investigator
	Colmar
	Hopital Louis Pasteur
		Jean-Claude Guillaume, MD	Ph: 33389124158
			Email: jeanclaude.guillaume@ch-colmar.rss.fr
		Jean-Claude Guillaume, MD	Principal Investigator
		Marie-Laure Batard, MD	Principal Investigator
	Créteil
	Centre Hospitalier Universitaire Henri Mondor
		Valérie Buffard, MD	Ph: 33149812501
			Email: valerie.buffard@hmn.aphp.fr
		Valérie Buffard, MD	Principal Investigator
		Martine Bagot, MD	Principal Investigator
	Paris
	Hopital Bichat - Claude Bernard
		Eve Maubec, MD	Ph: 33140257300
			Email: eve.maubec@bch.aphp.fr
		Eve Maubec, MD	Principal Investigator
		Béatrice Crickx, MD	Principal Investigator
	Hopital Cochin
		Marie-Françoise Avril, MD	Ph: 33158411781
			Email: marie-francoise.avril@cch.aphp.fr
		Marie-Françoise Avril, MD	Principal Investigator
		Nicolas Dupin, MD	Principal Investigator
	Hopital Saint-Louis
		Céleste Lebbé, MD	Ph: 0142499590
			Email: celeste.lebbe@sls.aphp.fr
		Céleste Lebbé, MD	Principal Investigator
		Delphine Kerob, MD	Principal Investigator
		Nicole Basset-Seguin, MD	Ph: 33142494932
			Email: nicole.basset-seguin@sls.aphp.fr
		Nicole Basset-Seguin, MD	Principal Investigator
		Catherine Vilmer, MD	Principal Investigator
	Reims
	CHU - Robert Debre
		Florent Grange, MD	Ph: 0326784368
			Email: fgrange@chu-reims.fr
		Florent Grange, MD	Principal Investigator
		Philippe Bernard, MD	Principal Investigator
	Rennes
	Centre Eugene Marquis
		Thierry Lesimple, MD	Ph: 02 99 25 31 95
			Email: lesimple@rennes.fnclcc.fr
		Thierry Lesimple, MD	Principal Investigator
	Centre Hospitalier Universitaire de Rennes
		Henri Adamski, MD	Ph: 33299284349
			Email: henri.adamski@chu-rennes.fr
		Henri Adamski, MD	Principal Investigator
		Jacqueline Chevrant-Breton, MD	Principal Investigator
	Rouen
	Hopital Charles Nicolle
		Philippe Musette, MD	Ph: 33232888054
			Email: Philippe.Musette@chu-rouen.fr
		Philippe Musette, MD	Principal Investigator
		Pascal Joly, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00240682
Information obtained from ClinicalTrials.gov on May 27, 2008