Status:
TERMINATED
Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study
Lead Sponsor:
Mayo Clinic
Conditions:
Stage 0a Renal Pelvis and Ureter Cancer AJCC v8
Stage 0a Renal Pelvis Cancer AJCC v8
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 can...
Detailed Description
PRIMARY OBJECTIVE: I. To determine the efficacy of a single intraoperative intravesical instillation of gemcitabine hydrochloride (gemcitabine) at time of radical nephroureterectomy (RNU) for clinica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04398368
Start Date
June 5 2020
End Date
February 2 2023
Last Update
August 8 2023
Active Locations (4)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
3
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
4
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232