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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

Tracking Information
First Submitted Date  ICMJE October 17, 2005
First Posted Date  ICMJE October 18, 2005
Last Update Posted Date February 22, 2012
Study Start Date  ICMJE October 2005
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2009)
Disease control rate assessed by CT or MRI [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2005)
Disease control rate at 6 weeks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2005)
  • - Safety profile.
  • - Time to disease progression.
  • - Overall survival.
  • - Duration of response in responder patients at 6 weeks.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR
Official Title  ICMJE 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.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Skin Diseases
  • Carcinoma, Squamous Cell
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: cetuximab
cetuximab
Intervention: Drug: cetuximab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2009)
37
Original Enrollment  ICMJE
 (submitted: October 17, 2005)
28
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00240682
Other Study ID Numbers  ICMJE 2005-001098-82
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier of Chartres
Study Sponsor  ICMJE Centre Hospitalier of Chartres
Collaborators  ICMJE Hospital of Chartres- France
Investigators  ICMJE
Principal Investigator: Eve Maubec, MD Dermatology Department, Hospital Bichat, Paris, France
PRS Account Centre Hospitalier of Chartres
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP