Esophageal Cancer Clinical Trial
Erlotinib in Treating Patients With Barrett Esophagus
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.
Full 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.
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
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