NCT00566800

Erlotinib in Treating Patients With Barrett Esophagus

Chemoprevention Trial Using Erlotinib in Barrett's Esophagus With High-Grade Dysplasia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Kansas City Veteran Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Esophageal Cancer
• Precancerous Condition

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride
OTHER	laboratory biomarker analysis
PROCEDURE	biopsy

Timeline

• Start date: 2007-07-01
• First posted: 2007-12-04
• Last updated: 2013-09-17

Locations

1 site across 1 country: United States