Erlotinib in Treating Patients With Barrett Esophagus

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kansas City Veteran Affairs Medical Center
• Treatments: Erlotinib Hydrochloride

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