Status:
COMPLETED
Evaluation the Treatment of Tamoxifen of Low/Intermediate Risk Bladder Tumors
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
Evaluate the treatment of tamoxifen of low/intermediate-risk bladder tumors
Detailed Description
Patients with primary or recurrent low/intermediate-risk papillary urothelial carcinoma of the bladder will undergo resection of all but one marker lesion, measuring at least 6mm but no greater than 1...
Eligibility Criteria
Inclusion
- Males and females age 21 or older. Histologic evidence of urothelial carcinoma of the bladder. Low/Intermediate-risk papillary urothelial carcinoma of the bladder, at initial occurrence or recurrent with \>6 months interval free of disease.
- Patients with multifocal tumors must have resectable lesions. Patients may be treatment-naïve or have failed 1 previous regimen of intravesical therapy.
- At least one endoscopically measurable tumor 6 - 10mm in diameter. Adequate hepatic and renal function. Patient or authorized proxy needs to have signed the informed consent form.
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Exclusion
- Patients with sessile appearing tumors, which may be invasive or high-grade. Diagnosis of urothelial carcinoma involving the prostatic urethra or upper urinary tract.
- Plans for pelvic radiation while participating in the study. Concurrent use of warfarin, heparin, or chronic use of NSAIDs, including aspirin (other than cardioprotective doses of 80mg daily) within 30 days prior to registration or during the trial.
- Concurrent use of selective serotonin reuptake inhibitors or aromatase inhibitors.
- Chronic or acute renal or hepatic disorder or any other condition, medical or psychological that, in the opinion of the investigator, could jeopardize the subject's safe participation.
- Any other investigational drug within 30 days prior to registration and during the study.
- Women Exclusion Pregnant or lactating women. Personal history of endometrial cancer or any abnormal uterine bleeding. Previous or concurrent treatment with SERM and/or hormonal replacement therapy within 3 months of the study.
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Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02197897
Start Date
April 1 2015
End Date
June 28 2019
Last Update
January 13 2021
Active Locations (2)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030
2
Harris Health System
Houston, Texas, United States, 77030