Esophageal Cancer Clinical Trial
Official title:
Chemoprevention Trial Using Erlotinib in Barrett's Esophagus With High-Grade Dysplasia
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming.
Erlotinib may keep esophageal cancer from forming in patients with Barrett esophagus by
blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with
Barrett esophagus.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
dysplasia.
- 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
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