The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer

The University of Chicago

Status: Terminated

Conditions: Esophageal Cancer

Treatments: Drug: sorafenib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00619242

14374B

Details and patient eligibility

About

To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe is important in the progression of cancer.

Full 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).

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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• A patient will be withdrawn from the study if any of the following events occur while on therapy: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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

sorafenib

Experimental group

Description:

sorafenib 2 tablets by mouth

Treatment:

Drug: sorafenib