Tamoxifen to Treat Barrett's Metaplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-09

Study Completion Date

2016-06-21

Brief Summary

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Treat Barrett's esophagus (BE) patients with tamoxifen to Barrett's metaplasia as measured by changes in Barrett's esophagus appearance by endoscopy and histology as well as changes in SOX2 and CDX2.

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Detailed Description

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Treat Barrett's esophagus (BE) patients with tamoxifen to determine the effects on Barrett's metaplasia as measured by changes in Barrett's esophagus appearance by endoscopy and histology. Tamoxifen treatment may induce SOX2 expression, decrease CDX2 and promote esophageal stem cell activity, leading to regression of Barrett's metaplasia. To test this hypothesis, we will conduct a prospective, pilot study where patients with BE, without high grade dysplasia, are treated with tamoxifen and assessed for changes in the appearance of their BE by endoscopy and histology as well as changes in the SOX2/CDX2 ratio indicative of an improvement in BE metaplasia

Conditions

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Barrett Metaplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Tamoxifen

Tamoxifen 20 mg daily for 12 weeks

Group Type EXPERIMENTAL

Tamoxifen

Intervention Type DRUG

Endoscopy

Intervention Type PROCEDURE

Interventions

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Tamoxifen

Intervention Type DRUG

Endoscopy

Intervention Type PROCEDURE

Other Intervention Names

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Nolvadex® Soltamox®

Eligibility Criteria

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Inclusion Criteria

* Biopsy-proven Barrett's esophagus that is non-dysplastic or with low grade dysplasia.
* At least 18 years of age.
* ECOG performance status ≤ 2
* Normal bone marrow and organ function as defined below:

* Absolute neutrophil count ≥1,500/mcl
* Platelets ≥ 100,000/mcl
* AST(SGOT)/ALT(SGPT) ≤1.5 x IULN
* Serum creatinine within normal institutional limits or less than the lower limit of normal institutional limits; or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
* Women of childbearing 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 must inform her treating physician immediately.
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria

* Prior history of esophageal cancer.
* Prior history or current use of tamoxifen or anti-estrogen therapy.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to tamoxifen.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant and/or breastfeeding. Female patients must have a negative urine pregnancy test within 14 days of study entry.
* Known HIV-positivity and on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with tamoxifen. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
* Taking medications known to affect drug metabolism via the CYP3A4, CYP2C9, or CYP2D6 pathways.
* History of blood clots (i.e. pulmonary embolism, DVTs).
* Concurrent use of anticoagulants (i.e. Coumadin/warfarin).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No