The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer

NCT00619242 | Terminated Results DMC

• 1 other identifier: 14374B
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

Esophageal cancer

Outcome Measures

Primary Outcomes (1)

• Ki-67

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

  Two weeks

Study Arms (1)

sorafenib

EXPERIMENTAL

sorafenib 2 tablets by mouth

Drug: sorafenib

Interventions

sorafenib DRUG

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

sorafenib

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• A patient will be withdrawn from the study if any of the following events occur while on therapy: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

Sponsors & Collaborators

• University of Chicago: lead
• Bayer: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Ezra Cohen, MD
• Organization: The University of Chicago

ecohen@medicine.bsd.uchicago.edu

773/702-4137

Study Officials

• Ezra Cohen, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 20, 2008
• Study Start: June 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 12, 2014
• Results First Posted: October 21, 2013

Record last verified: 2014-02

Locations

US (1)