A single-arm, two-stage, open-label, phase 2 study investigating the safety and efficacy of
intravesical gemcitabine/docetaxel for bacillus Calmette-Guerin (BCG)-nave patients with
non-muscle invasive bladder cancer (NMIBC). All participants will receive an induction course
of gemcitabine/docetaxel instillations followed by maintenance instillations if initial
efficacy is seen. In addition to providing initial efficacy data, this study will provide
safety and long-term efficacy data on the combination regimen studied. A tolerable safety
profile and demonstrated efficacy would support a potential, randomized phase 3 trial
comparing the experimental combination therapy and standard of care intravesical BCG therapy.
urinary tract neoplasm,
Transitional Cell Carcinoma of the Bladder,
Urothelial Carcinoma Bladder,
transitional cell carcinoma of bladder,
carcinoma of the bladder,
Clinical Study Identifier
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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