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Brief Title: Intravesical Gemcitabine in Patients With NMIBC

Phase II Trial of Intravesical Gemcitabine in Patients With Nonmuscle Invasive Bladder Cancer With or Without Prior Bacillus Calmette-Guérin Therapy

INTRODUCTION

  • Org Study ID: STUDY00000198
  • Secondary ID: N/A
  • NTC ID: NCT05644041
  • Sponsor: University of Arizona

BRIEF SUMMARY

Intravesical immunotherapy or chemotherapy for non-muscle invasive bladder cancer is a well-established treatment for preventing or delaying tumor recurrence after bladder tumor resection. For high-risk non-muscle invasive bladder cancer, immunotherapy in the form of intravesical Bacillus Calmette-Guérin (BCG) can be effective as first-line, nevertheless, the response rate to BCG is suboptimal with many patients failing treatment. Following BCG-failure, however, very few effective therapeutic options exist besides life-changing cystectomy. In addition, nationwide shortages of BCG have pushed the use of alternative intravesical therapies for non-muscle invasive bladder cancer. At Banner University Medical-Tucson, the use of intravesical Gemcitabine is considered as standard treatment for patients with bladder cancer who are unable to get BCG or have failed prior BCG treatment. The role of Gemcitabine as treatment for NBMIC is poorly understood. The purpose of this study is to gain a better understanding of the use of Gemcitabine intravesical chemotherapy for non-muscle invasive bladder cancer in a prospective cohort of patients.

  • Overall Status
    Recruiting
  • Start Date
    March 1, 2023
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Complete response rate (CR) for treatment with intravesical gemcitabine for patients with intermediate and high-risk NMIBC

Primary Outcome 1 - Timeframe: Complete response rate will be measured at the 3-month visit

CONDITION

  • Urinary Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
Patients able to consent in English or Spanish; provision of signed and dated informed consent form

- Stated willingness to comply with all study procedures and availability for the duration of the study

- Male or female ages ≥18 years.
Patients with intermediate or high-risk non-muscle-invasive UC of the bladder and no previous BCG treatment.
Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on Transurethral Resection of Bladder Tumor (TURBT) must be obtained within 180 days of registration. OR Patients with a high-grade recurrence after 24 months since last dose of BCG.
6. Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-2. 7. Post-transurethral bladder tumor resection. 8. Evidence of post-menopausal status or negative urinary pregnancy test of female pre-menopausal patients is required. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
Exclusion Criteria:
Known hypersensitivity reaction to gemcitabine.

- Clinical T2 or higher stage UC of the bladder.

- Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure CIS of the bladder.

- Active malignancies other than the disease being treated under study.

- Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage.

- Pregnant or breast-feeding women.

- Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Juan Chipollini, MD

Role: Principal Investigator

Affiliation: University of Arizona

Overall Contact

Name: Juan Chipollini, MD

Phone: (520) 626-6895, (520) 626-1183

Email: jchipollini@urology.arizona.edu, chum@arizona.edu

LOCATION

Facility Status Contact
Facility: University of Arizona Cancer Center
Tucson, Arizona 85721
United States 		Status: Recruiting Contact: Contact
UACC NCTN

UACC-NCTN@uacc.arizona.edu

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