Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer
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.
• 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.
• No visible disease based on cystoscopy 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.