Head and Neck Cancer Clinical Trial
Official title:
A Multi-Institutional Phase II Study of Radiation and GW572016 (Lapatinib) for Patients With Stage III-IV Head and Neck Cancer Who Cannot Tolerate Concurrent Chemoradiotherapy.
We propose to combine lapatinib with RT alone in patients with locally advanced head and neck cancer who cannot tolerate chemotherapy. The main objective of the study is to determine the efficacy of combining concurrent radiation and lapatinib in terms of time-to-progression (TTP) in this group of patients. In addition, we will determine the 2-year locoregional control rate (LRC), progression-free survival (PFS) and overall survival (OS) in these patients. We will also evaluate the profile and frequency of late toxicity, specifically mucosal and dermatologic toxicity, of the combination of lapatinib and RT in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).
There is substantial data to suggest that EGFR and Her-2/neu expressions are important
predictors for prognosis in HNSCC. EGFR blockade with a monoclonal antibody in conjunction
with radiotherapy has been shown to improve survival over radiotherapy alone in patients
with locally advanced HNSCC. Dual inhibition of EGFR and ErbB2 tyrosine kinases results in
greater inhibitory effect of the downstream signaling pathways in cancer cells than
inhibition of either receptor alone. Phase I studies in HNSCC suggested that the drug is
well tolerated when delivered either alone or concurrently with cisplatin based
chemoradiotherapy in HNSCC.
We propose to combine lapatinib with RT alone in patients with locally advanced HNSCC who
cannot tolerate chemotherapy. The main objective of the study is to determine the efficacy
of combining concurrent radiation and lapatinib in terms of time-to-progression (TTP) in
this group of patients. In addition, we will determine the 2-year locoregional control rate
(LRC), progression-free survival (PFS) and overall survival (OS) in these patients. We will
also evaluate the profile and frequency of late toxicity, specifically mucosal and
dermatologic toxicity, of the combination of lapatinib and RT in patients with locally
advanced HNSCC.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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