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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier of Chartres
• Collaborator: Hospital of Chartres- France
• Treatments: Cetuximab

Criteria

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.