NCT06488222

Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Subjects will receive 40 mg docetaxel intravesically.
DRUG	Gemcitabine	Subjects will receive 1 mg gemcitabine intravesically.

Timeline

• Start date: 2024-11-05
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2024-07-05
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study