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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00619242
Recruitment Status : Terminated (Low accrual)
First Posted : February 20, 2008
Results First Posted : October 21, 2013
Last Update Posted : March 12, 2014
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: sorafenib Not Applicable

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  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Effect of Sorafenib on Molecular Biomarkers in Barrett's Esophagus With High Grade Dysplasia
Study Start Date : June 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: sorafenib
sorafenib 2 tablets by mouth
Drug: sorafenib
2 tablets with water by mouth twice a day for two weeks.

Primary Outcome Measures :
  1. Ki-67 [ Time Frame: Two weeks ]
    Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett's esophagus.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00619242

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Ezra Cohen, MD University of Chicago

Responsible Party: University of Chicago Identifier: NCT00619242     History of Changes
Other Study ID Numbers: 14374B
First Posted: February 20, 2008    Key Record Dates
Results First Posted: October 21, 2013
Last Update Posted: March 12, 2014
Last Verified: February 2014

Keywords provided by University of Chicago:
Esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Barrett Esophagus
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Abnormalities
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs