Intravesical Gem/Doce in Patients With NMIBC

Inclusion Criteria:

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

2. Stated willingness to comply with all study procedures and availability for theduration 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 noprevious BCG treatment.

5. Histologically confirmed intermediate or high-risk non-muscle invasiveurothelial carcinoma of the bladder (Ta, T1, or Tis stage) on TransurethralResection of Bladder Tumor (TURBT) must be obtained within 180 days ofregistration. OR Patients with a high-grade recurrence after 24 months sincelast 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 and/or docetaxel.

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

3. Histopathology demonstrating any small cell component, pure adenocarcinoma, puresquamous 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) urothelialcarcinoma of any stage.

6. Pregnant or breast-feeding women.

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