Study of Dacomitinib With Radiotherapy With and Without Cisplatin in Patients With Squamous Cell Carcinoma of the Head and Neck
This is a phase 1 study of 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.
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 effectiveness.
Squamous Cell Carcinoma of the Head and Neck
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Maximum Tolerated Dose (in mg) of Dacomitinib [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Number of Participants with Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Number of Participants and Length of Time That Participants are Disease Free [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- Number of Participants who are Alive after 6 and 12 Months Post Completion of Treatment [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- Number of Participants and Length of Time That Participants do not Experience Distant Metastasis [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Dacomitinib with Radiotherapy
Dacomitinib, 15mg to 45mg orally, once daily. Radiotherapy, once daily (Monday to Friday) over six weeks.One day on weeks 2 to 6 the participants will receive treatment twice daily (bid).
Other Name: PF-00299804Radiation: Radiotherapy
Experimental: Dacomitinib and Chemoradiotherapy
Dacomitinib: 15mg to 45mg orally, once daily. Radiotherapy: Once daily (Monday to Friday) over seven weeks. Twice daily (bid) treatments may be introduced to compensate for treatment days missed due to statutory holidays, or machine maintenance. Cisplatin: 100mg/m2 intravenously; weeks 1, 4, and 7.
Other Name: PF-00299804Radiation: Radiotherapy Drug: Cisplatin
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737008
|Contact: Meghan Perry, B.Sc.Hons.||416-946-4501 ext firstname.lastname@example.org|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator: Lillian Siu, M.D.|
|Principal Investigator:||Lillian Siu, M.D.||Princess Margaret Cancer Centre/University Health Network|