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.
18 Years
N/A
Both
Skin Diseases, Carcinoma, Squamous Cell
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease control rate assessed by CT or MRI
Outcome Time Frame:
6 weeks
Safety Issue:
No
Principal Investigator
Eve Maubec, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dermatology Department, Hospital Bichat, Paris, France
Authority:
France: Ministry of Health
Study ID:
2005-001098-82
NCT ID:
NCT00240682
Start Date:
October 2005
Completion Date:
June 2009
Related Keywords:
- Skin Diseases
- Carcinoma, Squamous Cell
- Carcinoma, Squamous Cell
- Skin
- cetuximab
- epidermal growth factor receptor
- Carcinoma
- Carcinoma, Squamous Cell
- Skin Diseases
- Skin Neoplasms
- Carcinoma, Basal Cell
- Carcinoma, Basosquamous
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