Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR (CTXSCC)
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ClinicalTrials.gov Identifier: NCT00240682 |
Recruitment Status :
Completed
First Posted : October 18, 2005
Last Update Posted : February 22, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Skin Diseases Carcinoma, Squamous Cell | Drug: cetuximab | Phase 2 |
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 : | 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 |

Arm | Intervention/treatment |
---|---|
Experimental: cetuximab
cetuximab
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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 |
- Disease control rate assessed by CT or MRI [ Time Frame: 6 weeks ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Principal Investigator: | Eve Maubec, MD | Dermatology Department, Hospital Bichat, Paris, France |
Other Publications:
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 |
Carcinoma, Squamous Cell Skin cetuximab epidermal growth factor receptor |
Carcinoma Carcinoma, Squamous Cell Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms, Squamous Cell Cetuximab Antineoplastic Agents, Immunological Antineoplastic Agents |