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