Spots Global Cancer Trial Database for Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery

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Trial Identification

Brief Title: Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery

Official Title: A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer

Study ID: NCT00258297

Conditions

Esophageal Cancer

Interventions

gefitinib

conventional surgery

enzyme inhibitor therapy

neoadjuvant therapy

protein tyrosine kinase inhibitor therapy

surgery

Study Description

Brief Summary: 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.

Detailed Description: 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.