Actively Recruiting
Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer
Led by University of Florida · Updated on 2026-03-11
34
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age
- Low-grade (Ta) Intermediate risk urothelial carcinoma of the bladder (including recurrent low-grade Ta, solitary low-grade Ta > 3 cm, multifocal low-grade Ta)
- Up to 10% high-grade component allowed
- ECOG Performance Status of 0-2
- No evidence of upper tract urothelial carcinoma based on imaging (CT, MRI, or retrograde pyelograms)
- No urethral involvement based on cystoscopy
- No visible bladder disease within 60 days of enrollment
- Neutrophil counts 1500 cells/mm3
- Platelet counts > 100,000 cells/mm3
- Prior or concurrent malignancies allowed if not interfering with study safety or efficacy
- Subjects of childbearing potential must use contraception during the study and for 6 months after last dose
- Partners of child-bearing potential must use contraception during the study and for 3 months after last dose
- Written informed consent and agreement to comply with study procedures
You will not qualify if you...
- History of high-grade urothelial carcinoma of the bladder or upper urinary tracts
- Prior treatment with intravesical BCG
- Pure squamous cell carcinoma or adenocarcinoma
- Any neuroendocrine carcinoma component
- Anatomic abnormalities preventing urethral catheter placement
- Low bladder capacity preventing intravesical therapy
- Subjects of childbearing potential unwilling or unable to use contraception during study and 6 months after
- Pregnancy or breastfeeding
- Any disease or condition that contraindicates protocol therapy or interferes with study results
- Live virus vaccine within 30 days before first treatment dose
- Prisoners, involuntarily incarcerated, or compulsorily detained subjects
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
K
Karine Charles
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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