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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Tablets are administered orally or through a G-Tube, and can be taken with or without food.
Intensity modulated radiation therapy (IMRT) delivered using 4 or 6 MV photons. Patients will receive either the standard dose fractionation radiotherapy or accelerated fractionation radiotherapy.
If selected for this arm, cisplatin will be administered intravenously every three weeks after receiving premedications.
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Maximum Tolerated Dose (in mg) of Dacomitinib
Time frame: 1 year
To preliminarily evaluate the response rate of the combination of Dacomitinib, Cisplatin and Radiation
Time frame: 1 year
Levels of Dacomitinib in the Blood (Pharmacokinetics) in Combination with Cisplatin and Radiation
Time frame: Days 8, 22 and 43 (+2 day window) after initial dose
Disease free survival, overall survival and locoregional and distant metastasis free survival
Time frame: 6 and 12 months
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