Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR (CTXSCC)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Disease control rate assessed by CT or MRI [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Safety profile. [ Time Frame: during treatment or within 30 days after the final administration with a cut-off date at week 48. ] [ Designated as safety issue: Yes ]
- Time to disease progression. [ Time Frame: number of days from the start of treatment to the earliest day of progressive disease ] [ Designated as safety issue: No ]
- Overall survival. [ Time Frame: from the first infusion until week 48 or death ] [ Designated as safety issue: No ]
- Duration of response in responder patients at 6 weeks. [ Time Frame: time to disease progression ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||June 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
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.
Other Name: Erbitux
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240682
|Hospital of Caen|
|Caen, France, 14000|
|Hospital of Chartres|
|Chartres, France, 28018|
|Hospital Hôtel Dieu|
|Clermont-Ferrand, France, 63058|
|Clichy, France, 92110|
|CHR of Colmar|
|Colmar, France, 68000|
|Hospital Henri Mondor|
|Créteil, France, 94000|
|Hospital Saint-Louis, department of L. Dubertret|
|Paris, France, 75010|
|Hospital Saint Louis, Department of P. Morel|
|Paris, France, 75010|
|Paris, France, 75006|
|Paris, France, 75018|
|Hospital of Reims|
|Reims, France, 51100|
|Eugène Marquis Center|
|Rennes, France, 35042|
|Rennes, France, 35000|
|Hospital Charles Nicolle|
|Rouen, France, 76000|
|Principal Investigator:||Eve Maubec, MD||Dermatology Department, Hospital Bichat, Paris, France|