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


N/A
18 Years
65 Years
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

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


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).


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 with the following other concurrent illness are excluded:

- ongoing or active infection

- symptomatic congestive heart failure (NYHA Class II-IV)

- uncontrolled hypertension with either a systolic BP greater than 150 mmHg or
diastolic BP greater than 90 mmHg, despite optimal medical management.

- unstable angina pectoris

- cardiac arrhythmia except paroxysmal atrial fibrillation

- psychiatric illness/social situations that would limit compliance with study
requirements

- History of organ allograft, bone marrow, or peripheral blood stem cell transplant

- Known or suspected allergy to sorafenib

- Any unstable condition that could jeopardize the safety of the patient and/or her/his
compliance in the study

- Seizure disorder treated with steroid or anticonvulsant therapy

- Medical condition requiring anti-coagulation with full dose warfarin (target INR
greater than 2),heparin, low-molecular weight heparin, lepirudin, or argatroban.

- Thrombolic or embolic events such as a cerebrovascular accident including transient
ischemic attacks within the past 6 months.

- Pulmonary hemorrhage/bleeding event greater than CTCAE Grade 2 within 4 weeks of
first dose of study drug.

- Any other hemorrhage/bleeding event greater than CTCAE Grade 3 within 4 weeks of
first dose of study drug.

- Serious non-healing wound, ulcer, or bone fracture.

- Evidence or history of bleeding diathesis or coagulopathy

- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first
study drug.

- Use of St. John's Wort or rifampin (rifampicin).

- 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

- The effects of sorafenib on the developing human fetus at the recommended therapeutic
dose are unknown. For this reason and because small molecule cell proliferation
regulators may be teratogenic, women of child-bearing potential and men must agree to
use adequate contraception (hormonal or barrier method of birth control; abstinence)
prior to study entry and for the duration of study participation. Should a woman
become pregnant or suspect she is pregnant while participating in this study, she
should inform her treating physician immediately. Women of childbearing potential
must have a negative pregnancy test within 7 days of the start of treatment.

- 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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).

Outcome Time Frame:

2 weeks

Safety Issue:

Yes

Principal Investigator

Ezra Cohen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Food and Drug Administration

Study ID:

14374B

NCT ID:

NCT00619242

Start Date:

June 2006

Completion Date:

May 2011

Related Keywords:

  • Esophageal Cancer
  • Esophageal cancer
  • Barrett Esophagus
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

University of ChicagoChicago, Illinois  60637