Study on Gemcitabine and Docetaxel for Patients with Non-Muscle Invasive Bladder Cancer Who Have Not Received BCG Treatment
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials ID:NCT04386746
This clinical trial is testing a new treatment using gemcitabine and docetaxel for patients with non-muscle invasive bladder cancer who have not previously received BCG therapy. The study aims to evaluate the safety and effectiveness of this treatment.
Patient Parameters
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Program Overview
The study is designed to test the safety and effectiveness of a combination of two drugs, gemcitabine and docetaxel, for patients with non-muscle invasive bladder cancer who have not been treated with BCG. Participants will receive the treatment directly into the bladder once a week for six weeks. If the treatment shows initial success, monthly maintenance doses will follow. The study will help determine if this combination is safe and effective enough to be compared with the standard BCG treatment in future trials.
Description
Participants in this study will receive a treatment course of gemcitabine and docetaxel, administered directly into the bladder once a week for six weeks. If the treatment is initially effective, participants will continue to receive monthly doses to maintain the treatment's effects. The study will collect data on how safe the treatment is and how well it works over the long term. If the results are promising, this treatment could be tested in a larger trial against the standard BCG therapy for bladder cancer.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with intermediate or high-risk non-muscle invasive bladder cancer, confirmed by a recent procedure within 90 days.
- Must not have low-risk tumors as defined by specific criteria.
- Must be in good general health with a performance status score of 0, 1, or 2.
- Must be 18 years or older.
- Women must be post-menopausal or have a negative pregnancy test if of childbearing potential.
- Must provide written informed consent to participate.
Exclusion Criteria
- Have muscle-invasive or advanced bladder cancer that cannot be removed or has spread, as shown by recent imaging tests.
- Have cancer in the upper urinary tract unless previously treated and confirmed to be disease-free.
- Have another active cancer with a life expectancy of less than 12 months.
- Have received any anti-cancer treatment or radiotherapy within four weeks before starting the study treatment, or have not recovered from previous treatment side effects.
- Are pregnant or breastfeeding.
- Are unable or unwilling to follow the study protocol.
- Have previously used gemcitabine or docetaxel for a different type of cancer.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center | 21287 | Baltimore | Maryland |
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