The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer

This study has been terminated.
(Low accrual)
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00619242
First received: February 6, 2008
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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 Intervention
Esophageal Cancer
Drug: sorafenib

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Ki-67 [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
    Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett's esophagus.


Enrollment: 3
Study Start Date: June 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sorafenib
sorafenib 2 tablets by mouth
Drug: sorafenib
2 tablets with water by mouth twice a day for two weeks.
Other Name: Sorafenib

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619242

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Bayer
Investigators
Principal Investigator: Ezra Cohen, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00619242     History of Changes
Other Study ID Numbers: 14374B
Study First Received: February 6, 2008
Results First Received: September 23, 2009
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
Esophageal cancer

Additional relevant MeSH terms:
Barrett Esophagus
Esophageal Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014