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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR)
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.
via imaging every 12 weeks
Baurain Jean-Francois, Md,PhD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Belgium: Federal Agency for Medicinal Products and Health Products