Overview

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- A patient will be withdrawn from the study if any of the following events occur while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.