Chemoprevention Trial Using Erlotinib in Barrett's Esophagus With High-Grade Dysplasia
- To determine if erlotinib hydrochloride can be used as a chemopreventive agent that can
cause histologic regression of Barrett esophagus in patients at high risk of developing
esophageal cancer associated with high-grade dysplasia.
- To assess whether erlotinib hydrochloride can cause molecular alterations in EGFR,
phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy in Barrett esophagus
with high-grade dysplasia.
- To establish surrogate markers of chemoprevention in Barrett esophagus with high-grade
- To validate the histologic scoring of Barrett dysplasia developed by our group.
- To evaluate toxicities associated with the use of erlotinib hydrochloride in patients
with Barrett esophagus associated with high-grade dysplasia.
OUTLINE: Patients receive oral erlotinib hydrochloride once daily for 3 months. Patients
showing no evidence of progression to cancer by esophagogastroduodenoscopy (EGD) with biopsy
receive an additional 3 months of treatment. All patients then undergo repeat EGD, biopsy,
and determination of molecular markers (i.e., EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53,
PCNA, COX-2, and ploidy).
After completion of study treatment, patients are followed for 30 days.
Masking: Open Label, Primary Purpose: Treatment
Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride
Joaquina C. Baranda, MD
Kansas City Veteran Affairs Medical Center
|Veterans Affairs Medical Center - Kansas City||Kansas City, Missouri 64128|