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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer, Precancerous Condition

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Histologic regression of Barrett esophagus with high-grade dysplasia by chemoprevention with erlotinib hydrochloride

Safety Issue:

No

Principal Investigator

Joaquina C. Baranda, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kansas City Veteran Affairs Medical Center

Authority:

Unspecified

Study ID:

CDR0000576425

NCT ID:

NCT00566800

Start Date:

July 2007

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Precancerous Condition
  • esophageal cancer
  • Barrett esophagus
  • Barrett Esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Precancerous Conditions

Name

Location

Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128