Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study

Inclusion Criteria: * Clinical diagnosis of localized (clinical American Joint Committee on Cancer \[AJCC\] stage Ta-T4N0M0) low- and high-grade UC of the renal pelvis and/or ureter * Plan to undergo RNU * Creatinine \< 2.2 mg/dL (194 mmol/L) * Hemoglobin \> 9 g/dL * White blood cell count \>= 3000/uL * Platelet count \> 75,000/uL and \< 500,000/uL * Serum bilirubin levels below 2 times the institution's upper limits of normal * Alkaline phosphatase levels below 2 times the institution's upper limits of normal * Aspartate aminotransferase levels below 2 times the institution's upper limits of normal * Alanine aminotransferase levels below 2 times the institution's upper limits of normal * Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2 * Suitable candidate for surgery at the discretion of the investigator * Patient must be capable of giving appropriate approved informed consent or have an appropriate representative available to do * Patient with a prior malignancy allowed if adequately treated \> 3 years ago with no current evidence of disease * Women of childbearing potential (WOCBP) must have a negative pregnancy urine test within 28 days of registration, and be using an adequate method of contraception to avoid pregnancy prior to and for at least 6 months after gemcitabine instillation to minimize the risk of pregnancy * Male patient who has a partner that is a WOCBP must agree to use physician-approved contraceptive methods (e.g., abstinence, con…