Erlotinib in Treating Patients With Barrett Esophagus

NCT00566800 | Unknown Phase 1

• 3 other identifiers: CDR0000576425VAMCK-JB0027GENENTECH-OSI3717s
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer; Precancerous Condition

Keywords

esophageal cancer; Barrett esophagus

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• Molecular alterations in EGFR, phospho-EGFR, cyclin D1, cdc2, p16, p53, PCNA, COX-2, and ploidy

• Validation of histologic scoring of Barrett dysplasia

• Toxicity

Interventions

erlotinib hydrochloride DRUG

laboratory biomarker analysis OTHER

biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Kansas City Veteran Affairs Medical Center: lead

Study Sites (1)

Veterans Affairs Medical Center - Kansas City

Kansas City, Missouri, 64128, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Precancerous Conditions; Barrett Esophagus

Interventions

Erlotinib Hydrochloride; Biopsy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Joaquina C. Baranda, MD

  Kansas City Veteran Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: FED

Study Record Dates

• First Submitted: December 1, 2007
• First Posted: December 4, 2007
• Study Start: July 1, 2007
• Last Updated: September 17, 2013

Record last verified: 2008-01

Locations

US (1)