Recruitment

Recruitment Status
Terminated
Estimated Enrollment
30

Inclusion Criteria

ECOG performance status ≤ 2
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.
Biopsy-proven Barrett's esophagus that is non-dysplastic or with low grade dysplasia.
...
ECOG performance status ≤ 2
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.
Biopsy-proven Barrett's esophagus that is non-dysplastic or with low grade dysplasia.
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
At least 18 years of age.
Absolute neutrophil count ≥1,500/mcl
Ability to understand and willingness to sign an IRB approved written informed consent document.
Platelets ≥ 100,000/mcl
AST(SGOT)/ALT(SGPT) ≤1.5 x IULN

Exclusion Criteria

History of blood clots (i.e. pulmonary embolism, DVTs).
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.
Concurrent use of anticoagulants (i.e. Coumadin/warfarin).
...
History of blood clots (i.e. pulmonary embolism, DVTs).
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.
Concurrent use of anticoagulants (i.e. Coumadin/warfarin).
Taking medications known to affect drug metabolism via the CYP3A4, CYP2C9, or CYP2D6 pathways.
Prior history of esophageal cancer.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to tamoxifen.
Prior history or current use of tamoxifen or anti-estrogen therapy.
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.

Summary

Conditions
Barrett Metaplasia
Type
Interventional
Phase
Early Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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, leadin...

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

Inclusion Criteria

ECOG performance status ≤ 2
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.
Biopsy-proven Barrett's esophagus that is non-dysplastic or with low grade dysplasia.
...
ECOG performance status ≤ 2
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.
Biopsy-proven Barrett's esophagus that is non-dysplastic or with low grade dysplasia.
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
At least 18 years of age.
Absolute neutrophil count ≥1,500/mcl
Ability to understand and willingness to sign an IRB approved written informed consent document.
Platelets ≥ 100,000/mcl
AST(SGOT)/ALT(SGPT) ≤1.5 x IULN

Exclusion Criteria

History of blood clots (i.e. pulmonary embolism, DVTs).
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.
Concurrent use of anticoagulants (i.e. Coumadin/warfarin).
...
History of blood clots (i.e. pulmonary embolism, DVTs).
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.
Concurrent use of anticoagulants (i.e. Coumadin/warfarin).
Taking medications known to affect drug metabolism via the CYP3A4, CYP2C9, or CYP2D6 pathways.
Prior history of esophageal cancer.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to tamoxifen.
Prior history or current use of tamoxifen or anti-estrogen therapy.
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.

Tracking Information

NCT #
NCT02089386
Collaborators
Not Provided
Investigators
  • Principal Investigator: Jason Mills, M.D., Ph.D. Washington University School of Medicine
  • Jason Mills, M.D., Ph.D. Washington University School of Medicine
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