The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer (Barrett's)

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal cancer Read More

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• A patient will be withdrawn from the study if any of the following events occur while on therapy: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