870 Participants Needed

Gemcitabine + Docetaxel vs BCG for Bladder Cancer

(BRIDGE Trial)

Recruiting at 239 trial locations
MK
Overseen ByMax Kates, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eastern Cooperative Oncology Group
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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?

Research shows that the combination of Gemcitabine and Docetaxel is as effective as the traditional BCG treatment for intermediate-risk non-muscle-invasive bladder cancer, with similar recurrence rates and low progression to more severe disease.12345

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

My heart function is classified as class 2B or better, despite my history of heart issues or treatments.
I am older than 18 years.
I can understand and am willing to sign the consent form, or I have someone who can do it for me.
See 11 more

Exclusion Criteria

You cannot have had a serious allergic reaction to docetaxel or drugs containing polysorbate 80 in the past.
I had non-invasive bladder cancer, treated and confirmed clear on follow-up tests.
I am not planning to have children and will use or am using effective birth control.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravesical BCG or Gemcitabine + Docetaxel (GEMDOCE) for non-muscle invasive bladder cancer

6-12 weeks

Follow-up

Participants are monitored for event-free survival, quality of life, cystectomy-free survival, and progression-free survival

3 years

Treatment Details

Interventions

  • Bacillus Calmette Guerin
  • Docetaxel
  • Gemcitabine
Trial OverviewThe study compares the effectiveness of Gemcitabine + Docetaxel (GEMDOCE) versus Bacillus Calmette-Guerin (BCG) in treating patients new to BCG treatment for bladder cancer. It measures how long patients remain free from cancer events after these treatments and assesses quality of life, cystectomy-free survival, progression-free survival, safety, and toxicity.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment1 Intervention
BCG
Group II: Arm AExperimental Treatment2 Interventions
Gemcitabine + Docetaxel

Bacillus Calmette Guerin is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as BCG for:
  • Non-muscle invasive bladder cancer (NMIBC)
  • High-grade NMIBC
🇪🇺
Approved in European Union as Bacillus Calmette-Guérin for:
  • Non-muscle invasive bladder cancer (NMIBC)
  • High-grade NMIBC
  • Carcinoma in situ of the bladder
🇨🇦
Approved in Canada as BCG for:
  • Non-muscle invasive bladder cancer (NMIBC)
  • High-grade NMIBC
🇯🇵
Approved in Japan as Bacillus Calmette-Guérin for:
  • 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

Trials
272
Recruited
153,000+

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials
122
Recruited
160,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study of 107 patients with high-risk nonmuscle-invasive bladder cancer (NMIBC) treated with gemcitabine and docetaxel (Gem/Doce), the recurrence-free survival rates were high at 89%, 85%, and 82% at 6, 12, and 24 months, respectively, indicating the efficacy of this treatment in a BCG-naïve population.
The treatment was well-tolerated, with only one patient experiencing a grade 3 adverse event and no cases of disease progression or death from bladder cancer, suggesting that Gem/Doce is a safe alternative during the BCG shortage.
Sequential Intravesical Gemcitabine and Docetaxel for bacillus Calmette-Guérin-Naïve High-Risk Nonmuscle-Invasive Bladder Cancer.McElree, IM., Steinberg, RL., Martin, AC., et al.[2022]
Sequential intravesical gemcitabine/docetaxel (gem/doce) treatment for patients with BCG-unresponsive high-risk nonmuscle invasive bladder cancer showed promising efficacy, with 6-, 12-, and 24-month high-grade recurrence-free survival rates of 78%, 65%, and 49%, respectively, over a median follow-up of 18 months.
The treatment was generally well-tolerated, with mild to moderate adverse effects reported in 57% of patients, and only a small percentage (6.9%) experiencing treatment delays, indicating that gem/doce could be a safe alternative to radical cystectomy for these patients.
Sequential intravesical gemcitabine/docetaxel provides a durable remission in recurrent high-risk NMIBC following BCG therapy.Yim, K., Melnick, K., Mott, SL., et al.[2023]
In a study of 35 patients with non-muscle-invasive bladder cancer who experienced BCG treatment failure, sequential intravesical gemcitabine and docetaxel (gem/doce) showed a promising 60% progression-free survival rate at two years, indicating its efficacy as a salvage therapy.
The treatment was generally safe and well-tolerated, with only 37% of patients experiencing adverse events, and a high overall survival rate of 94% at two years, suggesting that gem/doce could be a viable option for patients who are not candidates for radical cystectomy.
Salvage therapy for BCG failure with intravesical sequential gemcitabine and docetaxel in patients with recurrent NMIBC.Garneau, CA., Marcotte, N., Lacombe, L., et al.[2023]

References

Sequential Intravesical Gemcitabine and Docetaxel for bacillus Calmette-Guérin-Naïve High-Risk Nonmuscle-Invasive Bladder Cancer. [2022]
Sequential intravesical gemcitabine/docetaxel provides a durable remission in recurrent high-risk NMIBC following BCG therapy. [2023]
Salvage therapy for BCG failure with intravesical sequential gemcitabine and docetaxel in patients with recurrent NMIBC. [2023]
Sequential intravesical gemcitabine and docetaxel therapy in patients with nonmuscle invasive bladder cancer: a systematic review and meta-analysis. [2023]
Sequential Intravesical Gemcitabine and Docetaxel is an Alternative to Bacillus Calmette-Guérin for the Treatment of Intermediate-risk Non-muscle-invasive Bladder Cancer. [2023]
Quality of Life, Efficacy, and Safety of Sequential Intravesical Gemcitabine + Docetaxel versus BCG for Non-Muscle Invasive Urinary Bladder Cancer: A Pilot Study. [2022]