Erlotinib in Treating Patients With Barrett Esophagus

Phase 1

• Conditions: Esophageal Cancer; Precancerous Condition

• Registration Number: NCT00566800
• Lead Sponsor: Kansas City Veteran Affairs Medical Center

Brief 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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-12-01
• Study First Submitted QC: 2007-12-01
• Study First Posted: 2007-12-04
• Status Verified: 2008-01
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride

Secondary Outcome Measures

Name	Time	Method
Molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy
Validation of histologic scoring of Barrett dysplasia
Toxicity

Trial Locations

Locations (1)

Veterans Affairs Medical Center - Kansas City; 🇺🇸 Kansas City, Missouri, United States