The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer

Stopped early · Not applicable

Conditions studied: Esophageal Cancer

In brief

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

Key facts

Study ID

NCT00619242

Run by

University of Chicago

People needed

3

Starts

2006-06-01

Expected to finish

2009-09-01

Last updated by the study team

2014-03-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• A patient will be withdrawn from the study if any of the following events occur while on therapy: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

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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