NCT00240682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2005

Typical duration for phase_2

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 22, 2012

Status Verified

August 1, 2009

Enrollment Period

3.5 years

First QC Date

October 17, 2005

Last Update Submit

February 18, 2012

Conditions

Skin DiseasesCarcinoma, Squamous Cell

Keywords

Carcinoma, Squamous CellSkincetuximabepidermal growth factor receptor

Outcome Measures

Primary Outcomes (1)

  • Disease control rate assessed by CT or MRI

    6 weeks

Secondary Outcomes (4)

  • Safety profile.

    during treatment or within 30 days after the final administration with a cut-off date at week 48.

  • Time to disease progression.

    number of days from the start of treatment to the earliest day of progressive disease

  • Overall survival.

    from the first infusion until week 48 or death

  • Duration of response in responder patients at 6 weeks.

    time to disease progression

Study Arms (1)

cetuximab

EXPERIMENTAL

cetuximab

Drug: cetuximab

Interventions

cetuximabDRUG

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.

Also known as: Erbitux
cetuximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hospital of Caen

Caen, 14000, France

Location

Hospital of Chartres

Chartres, 28018, France

Location

Hospital Hôtel Dieu

Clermont-Ferrand, 63058, France

Location

Beaujon's Hospital

Clichy, 92110, France

Location

CHR of Colmar

Colmar, 68000, France

Location

Hospital Henri Mondor

Créteil, 94000, France

Location

Hospital Tarnier-Cochin

Paris, 75006, France

Location

Hospital Saint Louis, Department of P. Morel

Paris, 75010, France

Location

Hospital Saint-Louis, department of L. Dubertret

Paris, 75010, France

Location

Hospital Bichat

Paris, 75018, France

Location

Hospital of Reims

Reims, 51100, France

Location

Hospital Pontchaillou

Rennes, 35000, France

Location

Eugène Marquis Center

Rennes, 35042, France

Location

Hospital Charles Nicolle

Rouen, 76000, France

Location

Related Publications (7)

  • Maubec E, Duvillard P, Velasco V, Crickx B, Avril MF. Immunohistochemical analysis of EGFR and HER-2 in patients with metastatic squamous cell carcinoma of the skin. Anticancer Res. 2005 Mar-Apr;25(2B):1205-10.

    PMID: 15865067BACKGROUND

  • Alam M, Ratner D. Cutaneous squamous-cell carcinoma. N Engl J Med. 2001 Mar 29;344(13):975-83. doi: 10.1056/NEJM200103293441306. No abstract available.

    PMID: 11274625BACKGROUND

  • Shimizu T, Izumi H, Oga A, Furumoto H, Murakami T, Ofuji R, Muto M, Sasaki K. Epidermal growth factor receptor overexpression and genetic aberrations in metastatic squamous-cell carcinoma of the skin. Dermatology. 2001;202(3):203-6. doi: 10.1159/000051637.

    PMID: 11385224BACKGROUND

  • Huang SM, Bock JM, Harari PM. Epidermal growth factor receptor blockade with C225 modulates proliferation, apoptosis, and radiosensitivity in squamous cell carcinomas of the head and neck. Cancer Res. 1999 Apr 15;59(8):1935-40.

    PMID: 10213503BACKGROUND

  • 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.

    BACKGROUND

  • 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).

    BACKGROUND

  • Maubec E, Petrow P, Scheer-Senyarich I, Duvillard P, Lacroix L, Gelly J, Certain A, Duval X, Crickx B, Buffard V, Basset-Seguin N, Saez P, Duval-Modeste AB, Adamski H, Mansard S, Grange F, Dompmartin A, Faivre S, Mentre F, Avril MF. Phase II study of cetuximab as first-line single-drug therapy in patients with unresectable squamous cell carcinoma of the skin. J Clin Oncol. 2011 Sep 1;29(25):3419-26. doi: 10.1200/JCO.2010.34.1735. Epub 2011 Aug 1.

    PMID: 21810686RESULT

MeSH Terms

Conditions

Skin DiseasesCarcinoma, Squamous Cell

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Eve Maubec, MD

    Dermatology Department, Hospital Bichat, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2005

First Posted

October 18, 2005

Study Start

October 1, 2005

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

February 22, 2012

Record last verified: 2009-08

Locations

FR(14)