Erlotinib in Treating Patients With Barrett Esophagus

Conditions:Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Age Range:18 - Any
Start Date:July 2007

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

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.



- 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.


- 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

- 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.


- Diagnosis of Barrett esophagus with high-grade dysplasia

- Refused surgery or other localized therapy for high-grade dysplasia

- No invasive esophageal carcinoma


- 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


- 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
We found this trial at
Kansas City, Missouri 64128
Kansas City, MO
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