34 Participants Needed

Gemcitabine + Docetaxel for Bladder Cancer

TW
Overseen ByTian White
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Bladder cancer is the 8th most common cancer in the UF Health Cancer Center catchment area and the 7th most common cancer presenting to UFHealth. Most newly diagnosed cases are stage I bladder cancer, which is defined by having no deep muscle invasion and no evidence of disease beyond the bladder. The current use in BCG (Bacillus Calmette-Guerin) refractory disease and the ongoing evaluation in BCG naïve high-risk disease support evaluation of intravesical gemcitabine and docetaxel in decreasing disease recurrence in intermediate risk stage I bladder cancer.This study will investigate the efficacy and subject compliance with treatment of low grade intermediate risk bladder cancer with intravesical gemcitabine and docetaxel.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer based on your specific situation.

Is the combination of gemcitabine and docetaxel generally safe for humans?

The combination of gemcitabine and docetaxel has been studied in several trials for advanced urothelial carcinoma, and these studies have evaluated its safety and toxicity. While specific side effects are not detailed here, these trials indicate that the combination has been tested for safety in humans.12345

How is the drug combination of Gemcitabine and Docetaxel unique for bladder cancer treatment?

The combination of Gemcitabine and Docetaxel is unique because it offers a well-tolerated, affordable option for second-line treatment in non-muscle-invasive bladder cancer that doesn't respond to standard BCG therapy. This combination uses two drugs with different mechanisms to effectively target cancer cells, providing a bladder-preserving alternative.25678

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 effective for treating advanced bladder cancer, especially in patients who have not responded to other treatments. This combination is well-tolerated and offers a good option for preserving the bladder in non-muscle-invasive bladder cancer.25679

Who Is on the Research Team?

PC

Paul Crispen, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

Adults over 18 with stage I low-grade bladder cancer that hasn't spread beyond the bladder or into deep muscle. Participants must have had all visible disease removed recently, no upper tract urothelial carcinoma, and no urethral involvement. They should not be severely ill (ECOG 0-2), able to use approved contraception methods, and have adequate neutrophil counts.

Inclusion Criteria

Neutrophil counts ≥ 1500 cells/mm3
I am able to get out of my bed or chair and move around.
Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 6 months after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
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Exclusion Criteria

I have a history of aggressive bladder cancer.
Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 6 months after the last dose of study drug
Subjects who are confirmed to be pregnant or breastfeeding
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive weekly intravesical gemcitabine and docetaxel for six weeks

6 weeks
6 visits (in-person)

Maintenance Treatment

Participants receive intravesical gemcitabine and docetaxel every 30 days

up to 12 months
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Docetaxel
  • Gemcitabine
Trial Overview The trial is testing a combination of two drugs, Gemcitabine and Docetaxel, given directly into the bladder (intravesical) for patients with intermediate risk stage I bladder cancer. It aims to see if this treatment can reduce disease recurrence and how well patients stick to it.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Docetaxel and GemcitabineExperimental Treatment2 Interventions

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

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Approved in United States as Taxotere for:
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Approved in European Union as Taxotere for:
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Approved in Canada as Taxotere for:
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Approved in Japan as Taxotere for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Published Research Related to This Trial

In a study of 59 patients with nonmuscle-invasive bladder cancer treated with intravesical gemcitabine/docetaxel (GEM/DOCE), the overall disease-free survival (DFS) was 49% at 1 year and 29% at 2 years, indicating that GEM/DOCE is a viable treatment option, especially for those who have failed previous therapies.
Patients who received monthly maintenance therapy after an initial complete response to GEM/DOCE had significantly better DFS rates (81% at 1 year) compared to those who were only observed (42% at 1 year), suggesting that maintenance therapy enhances long-term outcomes.
An evaluation of monthly maintenance therapy among patients receiving intravesical combination gemcitabine/docetaxel for nonmuscle-invasive bladder cancer.Daniels, MJ., Barry, E., Milbar, N., et al.[2022]
Intravesical gemcitabine and docetaxel therapy shows promising efficacy for high-risk nonmuscle invasive bladder cancer, with 1-year and 2-year recurrence-free survival rates of 86% and 84% in BCG-naive patients, and 80%, 66%, and 51% in BCG-unresponsive patients at 6 months, 1 year, and 2 years, respectively.
The treatment is generally well tolerated, with only 2.3% of patients unable to complete induction therapy and 6.9% experiencing delays or dose reductions due to adverse events, suggesting it could be a viable alternative to BCG therapy.
Sequential intravesical gemcitabine and docetaxel therapy in patients with nonmuscle invasive bladder cancer: a systematic review and meta-analysis.Kawada, T., Yanagisawa, T., Araki, M., et al.[2023]
In a Phase II trial involving 29 patients with advanced urothelial carcinoma, the combination of gemcitabine and docetaxel showed an overall response rate of 17%, indicating it can be an effective second-line treatment option for this patient group.
The treatment was associated with moderate toxicity, primarily granulocytopenia, anorexia, and fatigue, highlighting the need for careful monitoring, especially due to reported thromboembolic symptoms.
Phase II trial of gemcitabine and docetaxel in patients with advanced carcinoma of the urothelium: a trial of the Eastern Cooperative Oncology Group.Dreicer, R., Manola, J., Schneider, DJ., et al.[2022]

Citations

An evaluation of monthly maintenance therapy among patients receiving intravesical combination gemcitabine/docetaxel for nonmuscle-invasive bladder cancer. [2022]
Sequential intravesical gemcitabine and docetaxel therapy in patients with nonmuscle invasive bladder cancer: a systematic review and meta-analysis. [2023]
Phase II trial of gemcitabine and docetaxel in patients with advanced carcinoma of the urothelium: a trial of the Eastern Cooperative Oncology Group. [2022]
Weekly chemotherapy with docetaxel, gemcitabine and cisplatin in advanced transitional cell urothelial cancer: a phase II trial. [2022]
Sequential Gemcitabine plus Docetaxel Is the Standard Second-line Intravesical Therapy for BCG-unresponsive Non-muscle-invasive bladder cancer: Pro. [2022]
Sequential gemcitabine and cisplatin followed by docetaxel as first-line treatment of advanced urothelial carcinoma: a multicenter phase II study of the Hellenic Oncology Research Group. [2022]
Gemcitabine and docetaxel as first-line treatment for advanced urothelial carcinoma: a phase II study. [2022]
A phase II study of gemcitabine and docetaxel therapy in patients with advanced urothelial carcinoma. [2022]
Gemcitabine in the treatment of bladder cancer. [2022]
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