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Skin DiseasesPhase 2CTXSCCNCT00240682

Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR

A Phase 2 study testing cetuximab in people with Skin Diseases and Carcinoma, Squamous Cell, run by Centre Hospitalier of Chartres at 14 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Skin Diseases, Carcinoma, Squamous Cell
What is being tested?
cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
14 sitesFrance
Study dates
Oct 2005to Jun 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • Hospital of Caen

    Caen, 14000

  • Hospital of Chartres

    Chartres, 28018

  • Hospital Hôtel Dieu

    Clermont-Ferrand, 63058

  • Beaujon's Hospital

    Clichy, 92110

  • CHR of Colmar

    Colmar, 68000

  • Hospital Henri Mondor

    Créteil, 94000

  • Hospital Tarnier-Cochin

    Paris, 75006

  • Hospital Saint Louis, Department of P. Morel

    Paris, 75010

  • Hospital Saint-Louis, department of L. Dubertret

    Paris, 75010

  • Hospital Bichat

    Paris, 75018

  • Hospital of Reims

    Reims, 51100

  • Hospital Pontchaillou

    Rennes, 35000

  • Eugène Marquis Center

    Rennes, 35042

  • Hospital Charles Nicolle

    Rouen, 76000

Other trials in France

About this study

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.

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.

Read the 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.

Being tested
cetuximab
Keywords
Carcinoma, Squamous Cell, Skin, cetuximab, epidermal growth factor receptor
Medical subject headings
Skin Diseases, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cetuximabDrug

    Also called Erbitux

    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.

Study groups in NCT00240682
Study groupRoleWhat they receive
cetuximabExperimentalcetuximab
Receives: Drug: cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease control rate assessed by CT or MRI

    Measured: 6 weeks

Secondary outcomes (4)

  1. Safety profile.

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

  2. Time to disease progression.

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

  3. Overall survival.

    Measured: from the first infusion until week 48 or death

  4. Duration of response in responder patients at 6 weeks.

    Measured: time to disease progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionApr 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00240682
Sponsor's protocol ID
2005-001098-82
Other IDs
2005
Acronym
CTXSCC
Status last verified
Aug 2009
First submitted
17 Oct 2005
Last updated
22 Feb 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15865067

  • 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.

    PubMed 11274625

  • 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.

    PubMed 11385224

  • 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.

    PubMed 10213503

  • 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).

  • 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.

    PubMed 21810686

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab in people with Skin Diseases and Carcinoma, Squamous Cell, run by Centre Hospitalier of Chartres at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate assessed by CT or MRI (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00240682, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.

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