Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer
University of Florida
Summary
Bladder cancer is the 8th most common cancer in the UF Health Cancer Center catchment area and the 7th most common cancer presenting to UFHealth. Most newly diagnosed cases are stage I bladder cancer, which is defined by having no deep muscle invasion and no evidence of disease beyond the bladder. The current use in BCG (Bacillus Calmette-Guerin) refractory disease and the ongoing evaluation in BCG naïve high-risk disease support evaluation of intravesical gemcitabine and docetaxel in decreasing disease recurrence in intermediate risk stage I bladder cancer. This study will investigate the efficacy and subject compliance with treatment of low grade intermediate risk bladder cancer with intravesical gemcitabine and docetaxel.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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). Up to 10% high grade component is allowed. * 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. * No visible disease based on cystoscopy within 60 days of study enrollment. * Neutrophil counts ≥ 1500 cells/mm3 * Platelet counts \>100,000 cells/mm3 * Subjects with a…
Interventions
- DrugDocetaxel
Subjects will receive 40 mg docetaxel intravesically.
- DrugGemcitabine
Subjects will receive 1 mg gemcitabine intravesically.
Location
- University of FloridaGainesville, Florida