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Brief Title: Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study

GEMINI: An Open-Label, Single-Arm, Phase II Study of Intraoperative Gemcitabine Intravesical Instillation in Patients Undergoing Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma

INTRODUCTION

  • Org Study ID: 19-009444
  • Secondary ID: NCI-2020-03336, 19-009444, P30CA015083
  • NTC ID: NCT04398368
  • Sponsor: Mayo Clinic

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 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.

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
clinically localized upper tract urothelial carcinoma (UTUC) in preventing intravesical
recurrence of urothelial cancer (UC) at one year.

SECONDARY OBJECTIVES:

I. To assess time to recurrence for entire duration of follow-up. II. To assess the
qualitative and quantitative toxicities.

EXPLORATORY OBJECTIVES:

I. To stratify intravesical UC recurrence free survival by tumor grade, neoadjuvant
chemotherapy, tumor stage, ureteral tumor location, and history of bladder cancer.

II. To assess incidence and time to development of muscle-invasive bladder cancer (MIBC).

OUTLINE:

Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of
RNU.

After completion of study, patients are followed up at 2 weeks, and 3, 6, 12, 18, and 24
months.


  • Overall Status
    Recruiting
  • Start Date
    May 1, 2020
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Relapse-free survival

Primary Outcome 1 - Timeframe: Up to 24 months

Primary Outcome 2 - Measure: Relapse-free survival

Primary Outcome 2 - Timeframe: Up to 24 months

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

ELIGIBILITY


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

- 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 > 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)

- 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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Stephen A Boorjian

Role: Principal Investigator

Affiliation: Mayo Clinic

Overall Contact

Name: Stephen A Boorjian

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: Mayo Clinic
Rochester, Minnesota 55905
United States 		Status: Recruiting Contact:
Clinical Trials Referral Office
855-776-0015
mayocliniccancerstudies@mayo.edu

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