• Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride [ Designated as safety issue: No ]
  

• Molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy [ Designated as safety issue: No ]
  
• Validation of histologic scoring of Barrett dysplasia [ Designated as safety issue: No ]
  
• Toxicity [ Designated as safety issue: Yes ]
  

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.

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