Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study
Condition: Stage 0a Renal Pelvis and Ureter Cancer AJCC v8; Stage 0a Renal Pelvis Cancer AJCC v8; Stage 0a Ureter Cancer AJCC v8; Stage 0is Renal Pelvis and Ureter Cancer AJCC v8; Stage 0is Renal Pelvis Cancer AJCC v8; Stage 0is Ureter Cancer AJCC v8; Stage I Renal Pelvis and Ureter Cancer AJCC v8; Stage I Renal Pelvis Cancer AJCC v8; Stage I Ureter Cancer AJCC v8; Stage II Renal Pelvis and Ureter Cancer AJCC v8; Stage II Renal Pelvis Cancer AJCC v8; Stage II Ureter Cancer AJCC v8; Stage III Renal Pelvis and Ureter Cancer AJCC v8; Stage III Renal Pelvis Cancer AJCC v8; Stage III Ureter Cancer AJCC v8; Stage IV Renal Pelvis and Ureter Cancer AJCC v8; Stage IV Renal Pelvis Cancer AJCC v8; Stage IV Ureter Cancer AJCC v8
MeSH terms: Ureteral Neoplasms; Pelvic Neoplasms; Kidney Neoplasms
Intervention: Gemcitabine Hydrochloride
Intervention description: Given intravesically
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well gemcitabine works in preventing urothelial cancer from
      coming back within the bladder (intravesical recurrence) in patients with upper urinary tract
      urothelial cancer undergoing radical nephroureterectomy. Drugs used in chemotherapy, such as
      gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the
      cells, by stopping them from dividing, or by stopping them from spreading. Instilling
      gemcitabine into the bladder during surgery, may reduce the chance of recurrence of upper
      urinary tract urothelial cancer.
    

Eligibility criteria:

        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