This phase II trial tests how well intravesical gemcitabine and docetaxel works in treating patients with non-muscle invasive (that has not spread into healthy tissue) bladder cancer (NMIBC). Treatment given in the bladder (intravesical) is an established therapy for delaying or preventing bladder cancer from coming back after treatment (recurrence). Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Giving gemcitabine intravesically is poorly understood. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. This study will collect information on intravesical gemcitabine and docetaxel to better understand its effectiveness in patients with non-muscle invasive bladder cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT05644041.
Locations matching your search criteria
United States
Arizona
Tucson
Banner University Medical Center - TucsonStatus: Active
Contact: Juan Chipollini
Phone: 520-626-6895
PRIMARY OBJECTIVE:
I. To evaluate 3-month complete response rate (CR) for treatment with intravesical gemcitabine (gem)/docetaxel (doce) for patients with intermediate and high-risk NMIBC.
SECONDARY OBJECTIVES:
I. To evaluate durability of response in patients who achieve CR.
II. To assess tolerability and safety of the treatment.
III. To assess proportion of patients who accept maintenance therapy.
IV. To assess rate and reasons for cystectomy, if any.
EXPLORATORY OBJECTIVE:
I. Optional collection of specimens as part of standard of care for future exploratory research.
OUTLINE:
Patients receive gemcitabine intravesically, over 60 minutes, and docetaxel intravesically, over 60 minutes, once per week (QW) for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening, standard of care transurethral resection of bladder tumor on study, cystoscopy on study, biopsy per physician discretion on study, and collection of blood on study.
After completion of study treatment, patients are followed up at 3 months from first study visit then every 3 months for 1 year, per standard of care.
Lead OrganizationBanner University Medical Center - Tucson
Principal InvestigatorJuan Chipollini
