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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Subjects will receive 40 mg docetaxel intravesically.
Subjects will receive 1 mg gemcitabine intravesically.
University of Florida
Gainesville, Florida, United States
RECRUITINGRecurrence free survival
Evaluate the recurrence free survival, as measured by cystoscopy
Time frame: 12 months after start of induction
Progression rate
Determine the progression rate at 12 months, for tumor grade and stage, based on pathologic assessment of tumors in patients with disease recurrence. Development of the following will be considered progression: high grade disease, ≥ T1 disease, CIS.
Time frame: 12 months after start of induction
Treatment compliance
Determine treatment compliance, as measured by how many planned study treatments were given. This will be measured by documented administration of study treatments in the subject's medical record.
Time frame: 12 months after the start of induction
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.