The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer

Esophageal Cancer Clinical Trial

— Barrett's  

Official title:

A Pilot Study of the Effect of Sorafenib on Molecular Biomarkers in Barrett's Esophagus With High Grade Dysplasia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00619242
• Other study ID #: 14374B
• Status: Terminated
• Phase: N/A
• First received: February 6, 2008
• Last updated: February 10, 2014
• Start date: June 2006
• Est. completion date: September 2009

Study information

• Verified date: February 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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• A patient will be withdrawn from the study if any of the following events occur while on therapy: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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• sorafenib
2 tablets with water by mouth twice a day for two weeks.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ki-67	Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett's esophagus.	Two weeks	No