Esophageal Cancer
Conditions
Keywords
Esophageal cancer
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).
Interventions
DRUGsorafenib
2 tablets with water by mouth twice a day for two weeks.
Sponsors
Bayer
University of Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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* A patient will be withdrawn from the study if any of the following events occur while on therapy: * Interruption of scheduled therapy for greater than 7 days * Intolerable adverse effects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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ki-67 | Two weeks | Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett's esophagus. |
Countries
United States
Participant flow
Recruitment details
The study was activated and opened to accrual 06/19/2006. the study was terminated 7/17/2009. Subjects were seen in the University of Chicago outpatient clinics.
Pre-assignment details
Subjects must have histologically confirmed Barrett's esophagus with high-grade intraepithelial neoplasia (HGIN) or carcinoma in situ (CIS) on prior endoscopy within the previous 12 months.
Participants by arm
| Arm | Count |
|---|---|
| Sorafenib | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Sorafenib |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Ki-67
Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett's esophagus.
Time frame: Two weeks
Population: The 3 subjects underwent therapy without complications however the study was terminated due to low accrual.