Esophageal CancerBarrett'sNCT00619242
The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer
A study testing sorafenib in people with Esophageal Cancer, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- A patient will be withdrawn from the study if any of the following events occur while on therapy: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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of the Effect of Sorafenib on Molecular Biomarkers in Barrett's Esophagus With High Grade Dysplasia
To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe is important in the progression of cancer.
Read the 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).
- Conditions
- Esophageal Cancer
- Being tested
- sorafenib
- Keywords
- Esophageal cancer
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sorafenibDrug
2 tablets with water by mouth twice a day for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| sorafenib | Experimental | sorafenib 2 tablets by mouth Receives: Drug: sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ki-67
Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett's esophagus.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startJun 2006
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Ezra Cohen, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619242
- Sponsor's protocol ID
- 14374B
- Acronym
- Barrett's
- Status last verified
- Feb 2014
- First submitted
- 6 Feb 2008
- Last updated
- 12 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of Sorafenib on Molecular Biomarkers in Barrett's Esophagus With High Grade Dysplasia
- ClinicalTrials.gov ID
- NCT00619242
- Acronym / sponsor ID
- Barrett's / 14374B
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Jun 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Posted 21 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sorafenib | Experimental | Drug: sorafenibsorafenib 2 tablets by mouth |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (10 listed)
- A patient will be withdrawn from the study if any of the following events occur while on therapy:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sorafenib2 tablets with water by mouth twice a day for two weeks. | Drug | sorafenib |
Primary outcome
Ki-67
Time frame: Two weeks
Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett's esophagus.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ezra Cohen, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sorafenib in people with Esophageal Cancer, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ki-67 (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2014.