The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer

NCT ID: NCT00619242

Last Updated: 2014-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2009-09-30

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.

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).

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sorafenib

sorafenib 2 tablets by mouth

Group Type: EXPERIMENTAL

sorafenib

Intervention Type: DRUG

2 tablets with water by mouth twice a day for two weeks.

Interventions

sorafenib

2 tablets with water by mouth twice a day for two weeks.

Intervention Type: DRUG

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• A patient will be withdrawn from the study if any of the following events occur while on therapy: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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ezra Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

14374B

Identifier Type: -

Identifier Source: org_study_id