Tamoxifen Citrate in Treating Participants with Low/Intermediate-Risk Bladder Cancer

Inclusion Criteria

• 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-naive or have failed previous regimen of intravesical therapy
• At least one endoscopically measurable tumor 6 - 10mm in diameter
• Creatinine 0.6-1.3: MG/DL
• Blood urea nitrogen (BUN): 10-20 MG/DL
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]): 5-35 U/L
• Alanine aminotransferase (AST) (serum glutamate pyruvate transaminase [SGPT]): 7-56 U/L
• Gamma-glutamyl transpeptidase (GGT): 0-45 U/L
• Patient or authorized proxy needs to have signed the informed consent form

Exclusion Criteria

• 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 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
• Any subject who, in the opinion of the principal investigator (PI) is at risk for thromboembolic events
• Any patients taking drugs that are known to have drug interactions with tamoxifen will not be included
• Pregnant or lactating women
• Personal history of endometrial cancer or any abnormal uterine bleeding
• Previous or concurrent treatment with selective estrogen receptor modulator (SERM) and/or hormonal replacement therapy within 3 months of the study