Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR (CTXSCC)

This study has been completed.
Sponsor:
Collaborator:
Hospital of Chartres- France
Information provided by (Responsible Party):
Centre Hospitalier of Chartres
ClinicalTrials.gov Identifier:
NCT00240682
First received: October 17, 2005
Last updated: February 18, 2012
Last verified: August 2009
  Purpose

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 Intervention Phase
Skin Diseases
Carcinoma, Squamous Cell
Drug: cetuximab
Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier of Chartres:

Primary Outcome Measures:
  • Disease control rate assessed by CT or MRI [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 37
Study Start Date: October 2005
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240682

Locations
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 Saint-Louis, department of L. Dubertret
Paris, France, 75010
Hospital Tarnier-Cochin
Paris, France, 75006
Hospital Bichat
Paris, France, 75018
Hospital Saint Louis, Department of P. Morel
Paris, France, 75010
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
Principal Investigator: Eve Maubec, MD Dermatology Department, Hospital Bichat, Paris, France
  More Information

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).

Responsible Party: Centre Hospitalier of Chartres
ClinicalTrials.gov Identifier: NCT00240682     History of Changes
Other Study ID Numbers: 2005-001098-82
Study First Received: October 17, 2005
Last Updated: February 18, 2012
Health Authority: France: Ministry of Health

Keywords provided by Centre Hospitalier of Chartres:
Carcinoma, Squamous Cell
Skin
cetuximab
epidermal growth factor receptor

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Skin Diseases
Skin Neoplasms
Carcinoma, Basal Cell
Carcinoma, Basosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Neoplasms, Basal Cell
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014