Brief Title: Intravesical Gemcitabine in Patients With NMIBC

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

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

- 3. Male or female ages ≥18 years.

- 4. Patients with intermediate or high-risk non-muscle-invasive UC of the bladder and no previous BCG treatment.
1. 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:
1. Known hypersensitivity reaction to gemcitabine.

- 2. Clinical T2 or higher stage UC of the bladder.

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

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

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

- 6. Pregnant or breast-feeding women.

- 7. 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