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The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer
This study is currently recruiting participants.
Verified by University of Chicago, February 2009
First Received: February 6, 2008   Last Updated: February 13, 2009   History of Changes
Sponsors and Collaborators: University of Chicago
Bayer
Information provided by: University of Chicago
ClinicalTrials.gov Identifier: NCT00619242
  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

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders
Drug Information available for: Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Pilot Study of the Effect of Sorafenib on Molecular Biomarkers in Barrett's Esophagus With High Grade Dysplasia

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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). [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the safety and feasibility of administering sorafenib to patients with Barrett's esophagus and HGIN or CIS. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: June 2006
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
sorafenib: Experimental Drug: sorafenib
2 tablets with water by mouth twice a day for two weeks.

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 with the following other concurrent illness are excluded:

    • ongoing or active infection
    • symptomatic congestive heart failure (NYHA Class II-IV)
    • uncontrolled hypertension with either a systolic BP greater than 150 mmHg or diastolic BP greater than 90 mmHg, despite optimal medical management.
    • unstable angina pectoris
    • cardiac arrhythmia except paroxysmal atrial fibrillation
    • psychiatric illness/social situations that would limit compliance with study requirements
  • History of organ allograft, bone marrow, or peripheral blood stem cell transplant
  • Known or suspected allergy to sorafenib
  • Any unstable condition that could jeopardize the safety of the patient and/or her/his compliance in the study
  • Seizure disorder treated with steroid or anticonvulsant therapy
  • Medical condition requiring anti-coagulation with full dose warfarin (target INR greater than 2),heparin, low-molecular weight heparin, lepirudin, or argatroban.
  • Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
  • Pulmonary hemorrhage/bleeding event greater than CTCAE Grade 2 within 4 weeks of first dose of study drug.
  • Any other hemorrhage/bleeding event greater than CTCAE Grade 3 within 4 weeks of first dose of study drug.
  • Serious non-healing wound, ulcer, or bone fracture.
  • Evidence or history of bleeding diathesis or coagulopathy
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
  • Use of St. John's Wort or rifampin (rifampicin).
  • 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
  • The effects of sorafenib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because small molecule cell proliferation regulators may be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619242

Contacts
Contact: Ezra Cohen, MD 773/702-4137 ecohen@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Ezra Cohen, MD     773-702-4137     ecohen@medicine.bsd.uchicago.edu    
Principal Investigator: Ezra Cohen, MD            
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 ( Ezra Cohen, MD )
Study ID Numbers: 14374B
Study First Received: February 6, 2008
Last Updated: February 13, 2009
ClinicalTrials.gov Identifier: NCT00619242     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
Esophageal cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Esophageal Cancer
Protein Kinase Inhibitors
Digestive System Abnormalities
Digestive System Diseases
Esophageal Disorder
Barrett Syndrome
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Barrett Esophagus
Esophageal Diseases
Congenital Abnormalities
Sorafenib

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

ClinicalTrials.gov processed this record on May 07, 2009