What side effects are associated with this type of intervention?

Intravesical administration of chemotherapeutic agents such as Gemcitabine and Docetaxel for bladder cancer is generally well-tolerated but can cause some side effects. Commonly reported side effects include irritative bladder symptoms like dysuria (painful urination) and increased urinary frequency. Systemic absorption is minimal, reducing the risk of severe systemic side effects. However, patients may experience mild local reactions such as chemical cystitis, which is inflammation of the bladder lining. It is important to monitor renal function routinely during treatment to prevent potential renal complications.

What prior FDA approvals exist?

The FDA has approved several chemotherapeutic agents for the treatment of bladder cancer, particularly for non-muscle invasive bladder cancer (NMIBC). Intravesical Bacillus Calmette-Guérin (BCG) is a standard treatment for high-risk NMIBC. Gemcitabine, another chemotherapeutic agent, has been used intravesically and has shown efficacy with a favorable toxicity profile. While Docetaxel is more commonly used in systemic chemotherapy, its combination with Gemcitabine (GEMDOCE) is being studied for potential benefits in NMIBC. Other FDA-approved agents for bladder cancer include Mitomycin C, which is also administered intravesically. These treatments aim to reduce recurrence and progression of the disease.

What other types of research exist?

Promising novel alternatives to Gemcitabine + Docetaxel for bladder cancer patients include: 1) Atezolizumab and Pembrolizumab, which are checkpoint inhibitors showing efficacy in advanced urothelial carcinoma. 2) Enfortumab Vedotin, an antibody-drug conjugate effective in patients previously treated with platinum-based chemotherapy and checkpoint inhibitors. 3) Combination therapies involving radiation and radiosensitizing agents like fluorouracil and mitomycin, which have shown improved control in muscle-invasive bladder cancer. These alternatives represent significant advancements in the treatment landscape for bladder cancer.

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Vaccine

Gemcitabine + Docetaxel vs BCG for Bladder Cancer (BRIDGE Trial)

Phase 3

Recruiting

Research Sponsored by Eastern Cooperative Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be > 18 years of age.

Patient must have ECOG Performance Status 0-2.

Must not have

Patients with a history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment (i.e., either cytology, biopsy, or imaging) that demonstrates no evidence of residual disease are eligible.

Patient must not have any prior or current history of muscle-invasive (i.e., T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on radiographic imaging obtained within 90 days prior to randomization. The radiographic imaging includes a CT Scan OR MRI of the abdomen/pelvis with intravenous contrast.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects include allergic reactions to docetaxel or drugs containing polysorbate 80. Both GEMDOCE and BCG can cause immune system impacts leading to infection risks; GEMDOCE may also affect blood cell counts and liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I am able to care for myself and perform daily activities.

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I had hepatitis C but am cured, or I'm being treated with an undetectable viral load.

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My hepatitis B virus is under control with treatment.

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My visible bladder tumors have been surgically removed before joining this study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had non-invasive bladder cancer, treated and confirmed clear on follow-up tests.

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I have never had advanced or spreading bladder cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-Free Survival

Secondary study objectives

Cystectomy free survival

Progression Free Survival

Quality of Life EORTC NMIBC-24

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment1 Intervention

BCG

Group II: Arm AExperimental Treatment2 Interventions

Gemcitabine + Docetaxel

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~1920

Docetaxel

1995

Completed Phase 4

~6550

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Gemcitabine and Docetaxel are chemotherapeutic agents used in the treatment of bladder cancer, often administered intravesically. Gemcitabine works by inhibiting DNA synthesis, leading to cell death, while Docetaxel stabilizes microtubules, preventing cell division. These mechanisms are crucial as they target rapidly dividing cancer cells, reducing tumor growth. For bladder cancer patients, these treatments offer a non-surgical option that can preserve bladder function and improve quality of life. Additionally, BCG therapy, an immunotherapy, stimulates the immune system to attack cancer cells, and newer immunotherapies target specific pathways to enhance immune response. Understanding these mechanisms helps in selecting the most appropriate treatment based on individual patient needs and tumor characteristics.

[The role of immunotherapy in the modern treatment of urothelial carcinoma].Emerging drugs for urothelial carcinoma.