Phase I/II Study of Secondary Primary Tumor Prevention With Epidermal Growth Factor Receptor (EGFR), Tyrosine Kinase Inhibitor Erlotinib (OSI-774, Tarceva™ ), and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib) in Early Stage (Stage I/II) Squamous Cell Carcinoma of Head and Neck
This is a phase I/II study of second primary tumor prevention in early stage (stage I/II)
patients diagnosed with squamous cell carcinoma of the head and neck (SCCHN).
The study will evaluate the effect on cells and clinical response to study medications:
Epidermal Growth Factor Receptor (EGFR), Tyrosine Kinase Inhibitor Erlotinib (OSI-774,
Tarceva™ ), and Cyclooxygenase-2 (COX-2) Inhibitor (Celecoxib). The side effects of the
medications will be assessed, and chemicals in the cells will be evaluated both before and
after medication is administered that may show how the drugs work. This information will
help researchers determine whether additional studies with these drugs should be conducted
to determine if the drugs can help prevent pre-cancerous lesions from becoming cancerous.
SCCHN accounts for 5% of all cancer, and there is an incidence of approximately 37,200 new
cases in the United States per year with 11,000 deaths. The five-year survival rate for
patients with SCCHN in the United States and other developed countries is still poor,
approximately 40%, comparable to the five-year survival rate in the 1970s despite advances
in detection, surgery, radiation, and chemotherapy. Thus, a preventative approach before
the development of invasive cancer or second primary tumors (SPTs) is highly desirable and
novel strategies to reduce cancer incidence in SCCHN and other tobacco-carcinogen related
malignancies are being pursued.
Approximately 82 patients will participate at the Emory Winship Cancer Institute, Emory
Crawford Long Hospital, and Grady Memorial Hospital in Atlanta, Georgia.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Define biologic dose of Erlotinib and Celecoxib in Erlotinib plus Celecoxib in patients with early stage (I/II) SCCHN. Improve overall survival rate by reducing SPTs and recurrence with combination of Erlotinib and Celecoxib.
Dong Shin, MD
Emory University Winship Cancer Institute
United States: Institutional Review Board
|Emory University Winship Cancer Institute||Atlanta, Georgia 30322|