Chemoprevention Trial Using Erlotinib in Barrett's Esophagus With High-Grade Dysplasia
18 Years
N/A
Both
Esophageal Cancer, Precancerous Condition
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 City | Kansas City, Missouri 64128 |
