A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Esophageal Cancer
- Sponsor
- University of Rochester
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib