A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer
- Determine the safety and tolerability of neoadjuvant gefitinib in patients with
resectable stage I-III esophageal cancer.
- Determine the epidermal growth factor-receptor expression in tissue samples obtained at
diagnosis and surgery from patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive oral gefitinib once daily beginning between days -21 and -14 and continuing
until day -1. Patients undergo tumor resection on day 0.
After completion of study treatment, patients are followed periodically for 6 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib
Kishan J. Pandya, MD
James P. Wilmot Cancer Center
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|