The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer

Study Overview
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Brief Summary
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To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe is important in the progression of cancer.

Detailed Description
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To characterize the effects of sorafenib on specific molecular markers in patients with Barrett's esophagus and high grade intraepithelial neoplasia (HGIN) or carcinoma in situ (CIS).

Official Title
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A Pilot Study of the Effect of Sorafenib on Molecular Biomarkers in Barrett's Esophagus With High Grade Dysplasia

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: sorafenib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ECOG performance status 0-2 Life expectancy of greater than 12 months No prior history of esophageal surgery or endoscopic treatment of dysplasia No prior exposure to sorafenib Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy, with the exception of androgen ablating agents (for patients with prior prostate cancer) Age 18 years. Patients must have adequate organ and marrow function as defined below: hemoglobin: 8.5 g/dL absolute neutrophil count: 1,500/L platelets: 100,000/L (greater than 35,000/L without transfusion for less than 1 X the institutional upper limit of normal) creatinine less than 1.5 X institutional upper limit of normal Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: A patient will be withdrawn from the study if any of the following events occur while on therapy: Interruption of scheduled therapy for greater than 7 days Intolerable adverse effects which are judged by the investigator to be either physically or psychologically detrimental to the patient Patient decision to discontinue treatment Pregnancy Patient non-compliance with therapy administration Grade 3 or 4 NCI-CTC toxicity attributable to sorafenib Treatment with other chemotherapeutic or investigational anti-neoplastic drugs Disease progression HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib.Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sorafenib<br>sorafenib 2 tablets by mouth | Drug: sorafenib<br>* 2 tablets with water by mouth twice a day for two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ki-67 | Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett's esophagus. | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal cancer