Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN) Clinical Trial
Official title:
A Phase I Dose Escalation Trial of Neoadjuvant Sorafenib and Concurrent Sorafenib, Cisplatin and Radiation in Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN)
The purpose of this study is to assess the safety and determine MTD (maximal tolerated doses) and recommended doses of neoadjuvant sorafenib (BAY 43-9006) and concurrent sorafenib, cisplatin and radiation in the locally advanced squamous cell carcinomas of the head and neck (SCCHN)patient population.
Squamous cell carcinoma of the head and neck is a relatively common malignancy in both
Canada and the United States. Despite advancements made with the demonstration of improved
outcomes for concurrent platinum based chemotherapy with radical radiation in locally
advanced SCCHN, approximately 50% of cases will recur. The current treatment of
locoregionally recurrent/metastatic SCCHN is palliative in intent, with a median survival in
this population of 6-8 months. Thus improvements to the current backbone treatment of
locally advanced SCCHN, that is platinum based chemotherapy with radical radiation, are
desperately needed.
This is a non-randomized, open-label, phase I dose escalation trial of neoadjuvant Sorafenib
and concurrent Sorafenib, Cisplatin and radiation in locally advanced squamous cell
carcinomas of the head and neck (SCCHN).
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label