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An Open Label Multicentric Phase II Study of Panitumumab (Vectibix®) in Cutaneous Squamous Cell Carcinoma (SCC)

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Squamous Cell

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Trial Information

An Open Label Multicentric Phase II Study of Panitumumab (Vectibix®) in Cutaneous Squamous Cell Carcinoma (SCC)

This is an open-label, multicentric study of 17 patients with skin squamous cancer cell.

Eligible patients should not be suitable for immediate surgery. If they have only one tumor,
it should be greater than 3 cm2 in order to allow multiple biopsies.

Patients will receive six infusions of Panitumumab 6 mg/kg every 2 weeks or until
progression if earlier.

Patients will be assessed at baseline, at week 6 and then every 12 weeks till progression.
In addition to clinical examination, evaluation tools will include photography and CT-scan,
MRI or PET-scan.

Skin and tumor biopsies will be performed during first cycle at baseline and at days 2, 4,
8, 43, 85. Blood collections for translational research will be done during first cycle at
baseline and at days 2, 4, 8,15, 43, 85. Blood collection for hematology and chemistry
assessment will be done each 4weeks.

Patients presenting with a stable disease or a tumor response at week 12 will be eligible
for maintenance cycles consisting in an infusion of panitumumab every 2 weeks till

Inclusion Criteria

Inclusion criteria

- Patient with histologically confirmed diagnosis of SCC.

- Patient must not be candidate to direct curative surgery.

- Tumor evaluation by photography with a ruler and CT-scan, MRI or PET-scan must be
performed before enrollment.

- Age ≥ 18 years.

- Karnofsky Performance status (KPS) ≥70.

- Normal laboratory values:

- Platelet count ≥100x103/μL

- Leucocyte count ≥ 3x103/μL

- Hemoglobin ≥ 9 g/dL

- ASAT and ALAT ≤ 2.5xUNL

- Serum creatinine ≤1.5xUNL

- Total bilirubin ≤ 1.5xUNL

- Magnesium ≥ Lower Normal Limit (LLN)

- Calcium ≥ Lower Normal Limit (LLN)

- Patient should agree to perform biopsies and blood collections for translational

- Signed informed consent from the patient or legal representative must be obtained.

Exclusion criteria

- Clinically significant cardiovascular disease (including cardiac insufficiency NYHA
grade III and IV, unstable angina, arrythmia, myocardial infarction, symptomatic
congestive heart failure)in the past 12 months before enrollment.

- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
evidence of interstitial lung disease on baseline chest CT scan.

- No prior chemotherapy.

- Prior anti-EGFR therapy.

- Radiation within four weeks prior to trial entry.

- Subject pregnant or breastfeeding, or planning to become pregnant within 6 months
after the end of treatment.

- Subject (male or female) not willing to use highly effective methods of contraception
(per institutional standard) during treatment and for 6 months after the end of

- The patient has (or has had) previous or concomitant malignancies at other sites
within last 5years, except effectively treated malignancy that is considered by the
investigator highly likely to have been cured.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate (ORR)

Outcome Description:

To measure the efficacy of Panitumumab for SCC in terms of Overall Response Rate (ORR). Overall Response Rate (ORR) is defined as the sum of complete and partial tumour responses seen, divided by the total number of evaluable patients.

Outcome Time Frame:

via imaging every 12 weeks

Safety Issue:


Principal Investigator

Baurain Jean-Francois, Md,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cliniques universitaires Saint-Luc- Université Catholique de Louvain


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

Luc 09-002



Start Date:

August 2010

Completion Date:

July 2012

Related Keywords:

  • Carcinoma, Squamous Cell
  • Squamous cell carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell