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, condoms, vasectomy) and should avoid conceiving children prior to and for 6 months following gemcitabine instillation Exclusion Criteria: * Pure non-urothelial histology; urothelial carcinoma with differentiation allowed * Evidence of nodal or distant metastases; enlarged retroperitoneal lymph nodes \> 2 cm or histologically positive lymph nodes * History of UC of the bladder within 12 months preceding RNU, or receipt of intravesical therapy within 6 months * History of or current prostatic urethral, urethral, or contralateral upper tract UC * Planned radical cystectomy at time of RNU * Symptomatic urinary tract infection of bacterial cystitis (once satisfactorily treated, patients can enter the study) * Patient with any current malignancy except for basal or squamous cell skin cancers, noninvasive cancer of the cervix, or any other cancer deemed to be of low-risk for progression or patient morbidity during the trial period (i.e. Gleason 6 prostate cancer, renal mass \< 3 cm) * Women who are pregnant or breastfeeding * Prisoners or subjects who are involuntarily incarcerated * Inability for adequate follow-up, including concerns for patient compliance or geographic proximity