Overview
Tamoxifen to Treat Barrett's Metaplasia
Status:
Terminated
Terminated
Trial end date:
2016-06-21
2016-06-21
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Early Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Washington University School of MedicineTreatments:
Tamoxifen
Criteria
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).