Tongue Cancer Clinical Trial
Official title:
A Phase 2 Trial of GW572016 in Patients With Metastatic and Recurrent Squamous Cell Carcinomas of the Head and Neck
This phase II trial studies how well lapatinib ditosylate works in treating patients with metastatic or recurrent head and neck cancer. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. The primary objective of this study is to estimate the objective response rate (complete
response [CR] + partial response [PR]) in patients with squamous cell carcinomas of the head
and neck following treatment with GW572016 (lapatinib ditosylate).
SECONDARY OBJECTIVES:
I. Secondary objectives of this study are to estimate time to progression, describe the
adverse event profile, and to obtain preliminary assessments of changes in pre- versus
post-treatment measurements for selected biomarkers in tumor cells from these patients.
OUTLINE:
Patients receive lapatinib ditosylate orally (PO) once daily (QD). Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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