A Study to Evaluate Gemcitabine in Patients Undergoing Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma

Overview

About this study

The primary purpose of this study is to assess the effectiveness of a single intraoperative intravesical instillation of gemcitabine at time of radical nephroureterectomy (RNU) to prevent intravesical recurrence of urothelial carcinoma (UC) at 1 year in patients with clinically localized upper tract urothelial carcinoma (UTUC).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Males and females, age 18 years or older.
  • Clinical diagnosis of localized (clinical AJCC stage Ta-T4N0M0) low- and high-grade UC of the renal pelvis and/or ureter.
  • Plan to undergo RNU.
  • Adequate bone marrow, renal and hepatic function:
    • Creatinine < 2.2 mg/dL (194 mmol/L);
    • Adequate hematologic function (hemoglobin > 9 g/dL; white blood cell count ≥ 3000/μL; platelet count >75,000/μL and <500,000/μL);
    • Serum bilirubin, alkaline phosphatase, aspartate aminotransferase, and alanine aminotransferase levels below 2 times the institution’s upper limits of normal.
  • Easter 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.
  • 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 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 > 2cm 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.
  • History of radical cystectomy or partial cystectomy.
  • Planned radical cystectomy at time of RNU.
  • Symptomatic urinary tract infection of bacterial cystitis (once satisfactorily treated, patients can enter the study).
  • Women who are pregnant or breastfeeding.
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects who are involuntarily incarcerated.
  • Inability for adequate follow-up, including concerns for patient compliance or geographic proximity.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Stephen Boorjian, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Timothy Lyon, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20502628

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