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