NCT01737008

Dacomitinib Plus Radiotherapy, With and Without Cisplatin in Patients With Squamous Cell Carcinoma of the Head and Neck

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	dacomitinib	Tablets are administered orally or through a G-Tube, and can be taken with or without food.
RADIATION	Radiotherapy	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.
DRUG	Cisplatin	If selected for this arm, cisplatin will be administered intravenously every three weeks after receiving premedications.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-02-01
• Completion: 2015-05-01
• First posted: 2012-11-29
• Last updated: 2016-06-13

Locations

1 site across 1 country: Canada