This is an open label, monocentric, uncontrolled phase II trial with Dacomitinib, a pan-HER inhibitor, in unresectable or metastatic skin SCC. HER2 expression is common in skin SCC, being reported with high rates, even if in small studies. Coexpression of EGFR, HER2 and HER3 is present in skin SCCs but not in normal skin and it could be associated with the malignant phenotype. In this frame Dacomitinib could play a role in the increase of the response rate.
The patients will assume Dacomitinib 30 mg daily for the first 2 weeks. If the highest skin toxicity will be of grade \<2, then the patients will start dacomitinib at 45 mg once daily and they will be clinically assessed every cycle (i.e. every 28 days). If the highest skin toxicity will be grade \>2, then the patient will interrupt the treatment following the criteria for dose reduction. Tumor evaluation will be performed at baseline and every other cycle. Response will be assessed according to RECIST 1.1. The patient will continue to assume the study drug until disease progression, unacceptable toxicity or any medical condition that will suggest to stop the treatment for patient's safety
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
The patients will assume Dacomitinib 30 mg daily for the first 2 weeks. If the highest skin toxicity will be of grade \<2, then the patients will start dacomitinib at 45 mg once daily and they will be clinically assessed every cycle (i.e. every 28 days). If the highest skin toxicity will be grade \>2, then the patient will interrupt the treatment following the criteria for dose reduction.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Milan, Italy, Italy
Response rate to Dacomitinib
Response rate (partial response, PR + complete response, CR) to Dacomitinib
Time frame: 24 months
Compliance to the treatment and safety
Compliance to the treatment and safety
Time frame: 24 months
Disease control
Disease control (stable disease (SD) + PR + CR)
Time frame: 24 months
PFS and OS
Progression-Free Survival (PFS) and Overall Survival (OS)
Time frame: 24 months
Percentage of patients initially not considered for surgery due to difficulty to obtain a curative treatment that undergo surgery after dacomitinib
Percentage of patients initially not considered for surgery due to difficulty to obtain a curative treatment that undergo surgery after dacomitinib
Time frame: 24 months
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