The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer

• Status: Terminated
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: Bayer
• Treatments: Niacinamide; Sorafenib

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 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• A patient will be withdrawn from the study if any of the following events occur while on therapy: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.