Squamous Cell Carcinoma of the Head and Neck Clinical Trial
Official title:
Phase I Trial of Dacomitinib Concomitant With Radiotherapy With and Without Cisplatin in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
This is a phase 1 study of the drug dacomitinib with radiotherapy, with or without
chemotherapy, in patients with advanced squamous cell carcinoma of the head and neck
(SCCHN).
Dacomitinib is an oral drug, which is found to be active in SCCHN patients, blocks a
receptor called the epidermal growth factor receptor (EGFR). By blocking signals for cancer
cells to grow, it is believed to stop or slow the growth of tumor cells.
The dose escalation phase will find the best dose as well as determine the safety of
dacomitinib when given with radiotherapy and with or without chemotherapy.The dose expansion
phase will further test the best dose determined in the dose escalation phase for response
rate.
This is a phase 1 study of the investigational drug, dacomitinib, with radiotherapy and with
or without chemotherapy in patients with advanced squamous cell carcinoma of the head and
neck (SCCHN).
There are proteins found on the surface of cells called receptors that receive signals and
send signals to the cell to grow or to die. Dacomitinib is an oral drug that blocks a
receptor called the epidermal growth factor receptor (EGFR) which is found to be too active
in SCCHN patients. By blocking the signals for the cancer cells to grow, it is believed to
stop or slow the growth of tumor cells. The treatment of SCCHN usually includes chemotherapy
and radiation.
The primary objectives of this study will have two phases: a dose escalation phase and a
dose expansion phase. The dose escalation phase will find the best dose as well as determine
the safety of dacomitinib when given with radiotherapy and with or without chemotherapy.The
dose expansion phase will further test the best dose determined in the dose escalation phase
for safety and response rate.
The secondary objectives are to evaluate the pharmacokinetic properties of the combination
therapies, and to provide preliminary survival data.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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