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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
Sponsor:
Collaborator:
Hospital of Chartres- France
Information provided by (Responsible Party):
Centre Hospitalier of Chartres

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Skin Diseases Carcinoma, Squamous Cell Drug: cetuximab Phase 2

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : October 2005
Actual Primary Completion Date : April 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: cetuximab
cetuximab
 Drug: cetuximab
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


Outcome Measures
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Primary Outcome Measures :
  1. Disease control rate assessed by CT or MRI [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Safety profile. [ Time Frame: during treatment or within 30 days after the final administration with a cut-off date at week 48. ]
  2. Time to disease progression. [ Time Frame: number of days from the start of treatment to the earliest day of progressive disease ]
  3. Overall survival. [ Time Frame: from the first infusion until week 48 or death ]
  4. Duration of response in responder patients at 6 weeks. [ Time Frame: time to disease progression ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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France
Hospital of Caen
Caen, France, 14000
Hospital of Chartres
Chartres, France, 28018
Hospital Hôtel Dieu
Clermont-Ferrand, France, 63058
Beaujon's Hospital
Clichy, France, 92110
CHR of Colmar
Colmar, France, 68000
Hospital Henri Mondor
Créteil, France, 94000
Hospital Tarnier-Cochin
Paris, France, 75006
Hospital Saint Louis, Department of P. Morel
Paris, France, 75010
Hospital Saint-Louis, department of L. Dubertret
Paris, France, 75010
Hospital Bichat
Paris, France, 75018
Hospital of Reims
Reims, France, 51100
Hospital Pontchaillou
Rennes, France, 35000
Eugène Marquis Center
Rennes, France, 35042
Hospital Charles Nicolle
Rouen, France, 76000
Sponsors and Collaborators
Centre Hospitalier of Chartres
Hospital of Chartres- France
Investigators
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Principal Investigator: Eve Maubec, MD Dermatology Department, Hospital Bichat, Paris, France
More Information
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Publications of Results:

Other Publications:
Barbara A Burtness, Yi Li, William Flood, Bassam I Mattar, Arlene A Forastiere. Phase III trial comparing cisplatin (C) + placebo (P) to C + anti-epidermal growth factor antibody (EGF-R) C225 in patients (pts) with metastatic/recurrent head & neck cancer (HNC). Journal of Clinical Oncology,2002 ASCO Annual Meeting Proceedings. Abstract 901.
Nemunaitis JJ, Eiseman I, Cunningham C et al. A phase I trial of CI-1033, a pan-erbB tyrosine kinase inhibitor, given daily for 14 days every 3 weeks, in patients with advanced solid tumors. Proc Am Soc Clin Oncol 22: page 243, 2003 (abstr 974).

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Responsible Party: Centre Hospitalier of Chartres
ClinicalTrials.gov Identifier: NCT00240682    
Other Study ID Numbers: 2005-001098-82
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: August 2009
Keywords provided by Centre Hospitalier of Chartres:
Carcinoma, Squamous Cell
Skin
cetuximab
epidermal growth factor receptor
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents