Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery
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.
|Esophageal Cancer||Drug: gefitinib Procedure: conventional surgery Procedure: enzyme inhibitor therapy Procedure: neoadjuvant therapy Procedure: protein tyrosine kinase inhibitor therapy Procedure: surgery||Phase 2|
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer|
- Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib
|Study Start Date:||April 2004|
|Study Completion Date:||November 2006|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258297
|United States, New York|
|James P. Wilmot Cancer Center at University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Study Chair:||Kishan J. Pandya, MD||James P. Wilmot Cancer Center|