Gemcitabine + Docetaxel vs BCG for Bladder Cancer
(BRIDGE Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing whether a combination of two drugs, Gemcitabine and Docetaxel, given directly into the bladder, is effective for patients with high-grade non-muscle invasive bladder cancer who have not been treated with the standard therapy before. The goal is to see if this new treatment can prevent cancer from coming back or spreading. The study will also look at the quality of life, safety, and side effects of the new treatment. Gemcitabine and Docetaxel have shown promise as an alternative treatment, especially in cases where the standard therapy fails or is not tolerated.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
What data supports the effectiveness of the drug combination Gemcitabine and Docetaxel for bladder cancer?
Is the combination of Gemcitabine and Docetaxel safe for treating bladder cancer?
Studies have shown that the combination of Gemcitabine and Docetaxel is generally safe for treating non-muscle invasive bladder cancer, even in patients who have not responded to BCG therapy. While BCG can cause side effects, the Gemcitabine and Docetaxel combination has been evaluated for safety and is considered a viable alternative.12346
How does the drug combination of Gemcitabine and Docetaxel differ from BCG for bladder cancer?
The combination of Gemcitabine and Docetaxel is used as an alternative to BCG for treating non-muscle-invasive bladder cancer, especially when there is a shortage of BCG or when patients do not respond to BCG. This drug combination is administered directly into the bladder (intravesical therapy) and has shown similar effectiveness to BCG in preventing cancer recurrence.12345
Eligibility Criteria
This trial is for adults over 18 with high-grade non-muscle invasive bladder cancer who haven't had previous intravesical therapy, except perioperative chemo at TURBT time. They must have good performance status (able to carry out daily activities), no severe heart disease, and adequate organ function. Pregnant or breastfeeding individuals are excluded, as well as those with a history of muscle-invasive or advanced urothelial carcinoma.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravesical BCG or Gemcitabine + Docetaxel (GEMDOCE) for non-muscle invasive bladder cancer
Follow-up
Participants are monitored for event-free survival, quality of life, cystectomy-free survival, and progression-free survival
Treatment Details
Interventions
- Bacillus Calmette Guerin
- Docetaxel
- Gemcitabine
Bacillus Calmette Guerin is already approved in United States, European Union, Canada, Japan for the following indications:
- Non-muscle invasive bladder cancer (NMIBC)
- High-grade NMIBC
- Non-muscle invasive bladder cancer (NMIBC)
- High-grade NMIBC
- Carcinoma in situ of the bladder
- Non-muscle invasive bladder cancer (NMIBC)
- High-grade NMIBC
- Non-muscle invasive bladder cancer (NMIBC)
- High-grade NMIBC
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eastern Cooperative Oncology Group
Lead Sponsor
ECOG-ACRIN Cancer Research Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator