A Phase II Study Of GW572016 In Squamous Cell Carcinoma Of The Head And Neck (SCCHN)
I. Determine the overall response rate in patients with recurrent and/or metastatic squamous
cell carcinoma of the head and neck treated with lapatinib.
II. Determine the progression-free survival, time to progression, and overall survival of
patients treated with this drug.
III. Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 cohorts according to
prior epidermal growth factor receptor-targeted therapy (yes vs no).
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 40-88 patients (21-50 epidermal growth factor receptor [EGFR]
inhibitor-naive patients [cohort A] and 19-38 EGFR inhibitor-pre-treated patients [cohort
B]) will be accrued for this study within 4-12.6 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate by RECIST
The 95% confidence intervals should be provided.
Up to 6 years
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|