Evaluation the Treatment of Tamoxifen of Low/Intermediate Risk Bladder Tumors
Completed · Phase 2
Conditions studied: Bladder Cancer
In brief
Evaluate the treatment of tamoxifen of low/intermediate-risk bladder tumors
Key facts
- Study ID
- NCT02197897
- Run by
- Baylor College of Medicine
- People needed
- 15
- Starts
- 2015-04-01
- Expected to finish
- 2019-06-28
- Last updated by the study team
- 2021-01-13
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Baylor College of Medicine — Houston, Texas, United States
- Harris Health System — Houston, Texas, United States
Full record on ClinicalTrials.gov
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