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The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer - NCT00619242-60637(Clinical Trial 203519)



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City:  Chicago
State:  
IL
Zip Code: 60637
Conditions: Esophageal Cancer
Purpose: To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe is important in the progression of cancer.
Study summary: 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).
Criteria: 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 with the following other concurrent illness are excluded: - ongoing or active infection - symptomatic congestive heart failure (NYHA Class II-IV) - uncontrolled hypertension with either a systolic BP greater than 150 mmHg or diastolic BP greater than 90 mmHg, despite optimal medical management. - unstable angina pectoris - cardiac arrhythmia except paroxysmal atrial fibrillation - psychiatric illness/social situations that would limit compliance with study requirements - History of organ allograft, bone marrow, or peripheral blood stem cell transplant - Known or suspected allergy to sorafenib - Any unstable condition that could jeopardize the safety of the patient and/or her/his compliance in the study - Seizure disorder treated with steroid or anticonvulsant therapy - Medical condition requiring anti-coagulation with full dose warfarin (target INR greater than 2),heparin, low-molecular weight heparin, lepirudin, or argatroban. - Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months. - Pulmonary hemorrhage/bleeding event greater than CTCAE Grade 2 within 4 weeks of first dose of study drug. - Any other hemorrhage/bleeding event greater than CTCAE Grade 3 within 4 weeks of first dose of study drug. - Serious non-healing wound, ulcer, or bone fracture. - Evidence or history of bleeding diathesis or coagulopathy - Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug. - Use of St. John's Wort or rifampin (rifampicin). - 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 - The effects of sorafenib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because small molecule cell proliferation regulators may be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment. - 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.
Study is available at: University of Chicago
Chicago, IL 60637
United States

Primary Contact:
Ezra Cohen, MD
Email: ecohen@medicine.bsd.uchicago.edu
Phone: 773-702-4137

Secondary Contact:
Ezra Cohen, MD
Email: ecohen@medicine.bsd.uchicago.edu
Phone: 773/702-4137
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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