Clinical trial · Interventional
Tamoxifen to Treat Barrett's Metaplasia
NCT02089386CI-TRIAL-00026414terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Metaplasia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopy | Procedure | — | UNRESOLVED |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tamoxifen
- description
- Tamoxifen 20 mg daily for 12 weeks
- interventionNames
- Drug: Tamoxifen
- Procedure: Endoscopy
Primary outcomes (1)
- measure
- Extent of Barrett's involvement and changes in histology
- timeFrame
- End of 12 weeks (at the time of second endoscopy)
- description
- The biopsy procedures with 4 quadrant biopsies/2 cm for histology and additional biopsies for freezing for macromolecular analysis to assess the preliminary diagnostic value of this marker pair in identifying levels of metaplasia in BE and as an indicator of response to tamoxifen treatment. The tissue from the two endoscopic procedures will be assessed for changes in the following related to tamoxifen therapy.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (2)
- BACKGROUNDLindblad M, Garcia Rodriguez LA, Chandanos E, Lagergren J. Hormone replacement therapy and risks of oesophageal and gastric adenocarcinomas. Br J Cancer. 2006 Jan 16;94(1):136-41. doi: 10.1038/sj.bjc.6602906. PMID 16404367
- BACKGROUNDHuh WJ, Khurana SS, Geahlen JH, Kohli K, Waller RA, Mills JC. Tamoxifen induces rapid, reversible atrophy, and metaplasia in mouse stomach. Gastroenterology. 2012 Jan;142(1):21-24.e7. doi: 10.1053/j.gastro.2011.09.050. Epub 2011 Oct 14. PMID 22001866