Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
25 participants
INTERVENTIONAL
2007-07-31
Brief Summary
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PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with Barrett esophagus.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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erlotinib hydrochloride
laboratory biomarker analysis
biopsy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Kansas City Veteran Affairs Medical Center
FED
Principal Investigators
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Joaquina C. Baranda, MD
Role: PRINCIPAL_INVESTIGATOR
Kansas City Veteran Affairs Medical Center
Locations
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Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States
Countries
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Facility Contacts
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Joaquina C. Baranda, MD
Role: primary
Other Identifiers
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VAMCK-JB0027
Identifier Type: -
Identifier Source: secondary_id
GENENTECH-OSI3717s
Identifier Type: -
Identifier Source: secondary_id
CDR0000576425
Identifier Type: -
Identifier Source: org_study_id