Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR (CTXSCC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00240682|
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : February 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Skin Diseases Carcinoma, Squamous Cell||Drug: cetuximab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||June 2009|
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
- Disease control rate assessed by CT or MRI [ Time Frame: 6 weeks ]
- Safety profile. [ Time Frame: during treatment or within 30 days after the final administration with a cut-off date at week 48. ]
- Time to disease progression. [ Time Frame: number of days from the start of treatment to the earliest day of progressive disease ]
- Overall survival. [ Time Frame: from the first infusion until week 48 or death ]
- Duration of response in responder patients at 6 weeks. [ Time Frame: time to disease progression ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Paris, France, 75006|
|Hospital Saint Louis, Department of P. Morel|
|Paris, France, 75010|
|Hospital Saint-Louis, department of L. Dubertret|
|Paris, France, 75010|
|Paris, France, 75018|
|Hospital of Reims|
|Reims, France, 51100|
|Rennes, France, 35000|
|Eugène Marquis Center|
|Rennes, France, 35042|
|Hospital Charles Nicolle|
|Rouen, France, 76000|
|Principal Investigator:||Eve Maubec, MD||Dermatology Department, Hospital Bichat, Paris, France|