Esophageal Cancer Clinical Trial
Official title:
A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Giving gefitinib before surgery may shrink the tumor so that it can
be removed.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with
stage I, stage II, or stage III esophageal cancer that can be removed by surgery.
OBJECTIVES:
Primary
- Determine the safety and tolerability of neoadjuvant gefitinib in patients with
resectable stage I-III esophageal cancer.
Secondary
- 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
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