Erlotinib in Treating Patients With Barrett Esophagus

Study Overview
=================
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.

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

Conditions
-----------------
Esophageal Cancer, Precancerous Condition

Intervention / Treatment
-----------------
* Drug: erlotinib hydrochloride
* Other: laboratory biomarker analysis
* Procedure: biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of Barrett esophagus with high-grade dysplasia Refused surgery or other localized therapy for high-grade dysplasia No invasive esophageal carcinoma PATIENT CHARACTERISTICS: ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 10 g/dL Bilirubin normal AST and ALT < 3 times upper limit of normal (ULN) Alkaline phosphatase < 3 times ULN No uncontrolled medical condition Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 1 week after completion of study treatment Able to swallow tablets or dissolved tablets No known hypersensitivity to erlotinib hydrochloride No symptoms suggestive of malignancy (e.g., weight loss or vomiting) No history of other malignancies No uncontrolled medical or psychiatric condition that would preclude treatment under this clinical trial PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior exposure to erlotinib hydrochloride No concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal therapy No concurrent investigational agents

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: erlotinib hydrochloride|nan|
|Other: laboratory biomarker analysis|nan|
|Procedure: biopsy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy |  |  | 
| Validation of histologic scoring of Barrett dysplasia |  |  | 
| Toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophageal cancer, Barrett esophagus