Status:
TERMINATED
The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Bayer
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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.
Detailed Description
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).
Eligibility Criteria
Inclusion
- 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
- A patient will be withdrawn from the study if any of the following events occur while on therapy: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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00619242
Start Date
June 1 2006
End Date
September 1 2009
Last Update
March 12 2014
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637