The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer

Not Applicable

Terminated

• Conditions: Esophageal Cancer
• Interventions: Drug: sorafenib

• Registration Number: NCT00619242
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-06
• Study First Submitted: 2008-02-06
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-20
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2009-09-23
• Results First Submitted QC: 2013-08-14
• Results First Posted: 2013-10-21
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-03-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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• A patient will be withdrawn from the study if any of the following events occur while on therapy: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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sorafenib	sorafenib	sorafenib 2 tablets by mouth

Primary Outcome Measures

Name	Time	Method
Ki-67	Two weeks	Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett's esophagus.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States