- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00619242
The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer (Barrett's)
February 10, 2014 updated by: University of Chicago
A Pilot Study of the Effect of Sorafenib on Molecular Biomarkers in Barrett's Esophagus With High Grade Dysplasia
To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe is important in the progression of cancer.
Study Overview
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).
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60637
- University Of Chicago
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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A patient will be withdrawn from the study if any of the following events occur while on therapy: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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sorafenib
sorafenib 2 tablets by mouth
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2 tablets with water by mouth twice a day for two weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ki-67
Time Frame: Two weeks
|
Biomarker.
Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett's esophagus.
|
Two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ezra Cohen, MD, University Of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
February 6, 2008
First Submitted That Met QC Criteria
February 19, 2008
First Posted (Estimate)
February 20, 2008
Study Record Updates
Last Update Posted (Estimate)
March 12, 2014
Last Update Submitted That Met QC Criteria
February 10, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Precancerous Conditions
- Esophageal Neoplasms
- Barrett Esophagus
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Sorafenib
Other Study ID Numbers
- 14374B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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