Gemcitabine + Docetaxel for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer based on your specific situation.
Is the combination of gemcitabine and docetaxel generally safe for humans?
The combination of gemcitabine and docetaxel has been studied in several trials for advanced urothelial carcinoma, and these studies have evaluated its safety and toxicity. While specific side effects are not detailed here, these trials indicate that the combination has been tested for safety in humans.12345
How is the drug combination of Gemcitabine and Docetaxel unique for bladder cancer treatment?
The combination of Gemcitabine and Docetaxel is unique because it offers a well-tolerated, affordable option for second-line treatment in non-muscle-invasive bladder cancer that doesn't respond to standard BCG therapy. This combination uses two drugs with different mechanisms to effectively target cancer cells, providing a bladder-preserving alternative.25678
What data supports the effectiveness of the drug combination Gemcitabine and Docetaxel for bladder cancer?
Research shows that the combination of Gemcitabine and Docetaxel is effective for treating advanced bladder cancer, especially in patients who have not responded to other treatments. This combination is well-tolerated and offers a good option for preserving the bladder in non-muscle-invasive bladder cancer.25679
Who Is on the Research Team?
Paul Crispen, MD
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
Adults over 18 with stage I low-grade bladder cancer that hasn't spread beyond the bladder or into deep muscle. Participants must have had all visible disease removed recently, no upper tract urothelial carcinoma, and no urethral involvement. They should not be severely ill (ECOG 0-2), able to use approved contraception methods, and have adequate neutrophil counts.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive weekly intravesical gemcitabine and docetaxel for six weeks
Maintenance Treatment
Participants receive intravesical gemcitabine and docetaxel every 30 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Docetaxel
- Gemcitabine
Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor