Brief Title: Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Recurrence free survival

Primary Outcome 1 - Timeframe: 12 months after start of induction

CONDITION

• Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
* Adults ≥ 18 years of age.

- * Low-grade (Ta) Intermediate risk urothelial carcinoma of the bladder (defined as recurrent low-grade Ta, solitary low-grade Ta > 3 cm, multifocal low-grade Ta)

- * ECOG Performance Status of 0-2.

- * No evidence of upper tract urothelial carcinoma based on CT, MRI, or retrograde pyelograms.

- * No urethral involvement based on cystoscopy.

- * All visible disease based on cystoscopy resected within 60 days of study enrollment.

- * Neutrophil counts ≥ 1500 cells/mm3

- * Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen [as determined by the treating physician or approved by the PI] may be included.

- * Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 6 months after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.

- * Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 3 months following the last dose of study drug.

- * Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
Exclusion Criteria:
* Subjects who have a history of high-grade urothelial carcinoma of the bladder or upper tracts

- * Prior treatment with intravesical BCG

- * Pure squamous cell carcinoma or adenocarcinoma

- * Any component of neuroendocrine carcinoma

- * Anatomic abnormalities that prohibit urethral catheter placement

- * Low bladder capacity (determined by the treating Urologist) which prohibits treatment with intravesical therapy.

- * Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 6 months after the last dose of study drug.

- * Subjects who are confirmed to be pregnant or breastfeeding.

- * History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.

- * Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose.

- * Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Paul Crispen, MD

Role: Principal Investigator

Affiliation: University of Florida

Overall Contact

Name: Tian White

Phone: 352-733-0598

Email: [email protected]

LOCATION