Gemcitabine + Docetaxel for Bladder Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Paul Crispen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Florida

Must not be taking: Live virus vaccines

Disqualifiers: High-grade carcinoma, BCG treatment, others

No Placebo Group

Prior Safety Data

Trial Summary

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.

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.

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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.

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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.

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Eligibility Criteria

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

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

Trial Timeline

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

Participant Groups

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.

Group I: Docetaxel and Gemcitabine Experimental Treatment 2 Interventions

All subjects will be treated with docetaxel and gemcitabine in 2 phases (induction and maintenance) following transurethral resection. Docetaxel and gemcitabine will be given weekly for six weeks during induction and will then be given every 30 days until up to 12 months after the start of induction therapy during maintenance.

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

🇺🇸 Approved in United States as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

🇪🇺 Approved in European Union as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

🇨🇦 Approved in Canada as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

🇯🇵 Approved in Japan as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Florida Gainesville, FL

Who Is Running the Clinical Trial?

University of Florida Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

An evaluation of monthly maintenance therapy among patients receiving intravesical combination gemcitabine/docetaxel for nonmuscle-invasive bladder cancer. [2022] To report our experience with sequential maintenance intravesical gemcitabine/docetaxel (GEM/DOCE) for patients with nonmuscle-invasive bladder cancer.

2. United States pubmed.ncbi.nlm.nih.gov

Sequential intravesical gemcitabine and docetaxel therapy in patients with nonmuscle invasive bladder cancer: a systematic review and meta-analysis. [2023] Shortages in intravesical Bacillus Calmette-Guérin (BCG) immunotherapy represent a challenge in the management of high-risk nonmuscle invasive bladder cancer (HR-NMIBC). This study aimed to review the efficacy and safety of intravesical gemcitabine (GEM) and docetaxel (DOCE) for BCG-naive and unresponsive HR-NMIBC.

3. United States pubmed.ncbi.nlm.nih.gov

Phase II trial of gemcitabine and docetaxel in patients with advanced carcinoma of the urothelium: a trial of the Eastern Cooperative Oncology Group. [2022] Gemcitabine and docetaxel are active agents in advanced urothelial carcinoma. A Phase II trial of this combination was performed to determine the activity and toxicity of these agents in a multiinstitutional setting in patients previously treated with one prior chemotherapy regimen.

4. England pubmed.ncbi.nlm.nih.gov

Weekly chemotherapy with docetaxel, gemcitabine and cisplatin in advanced transitional cell urothelial cancer: a phase II trial. [2022] To evaluate the efficacy and toxicity of a combination of weekly docetaxel, gemcitabine and cisplatin in advanced transitional cell carcinoma (TCC) of the bladder.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Sequential Gemcitabine plus Docetaxel Is the Standard Second-line Intravesical Therapy for BCG-unresponsive Non-muscle-invasive bladder cancer: Pro. [2022] Docetaxel and gemcitabine have different mechanisms of action, are well tolerated as monotherapies, and are affordable. This combination represents a good option for the second-line, bladder-preserving standard of care for non-muscle-invasive bladder cancer unresponsive to bacillus Calmette-Guérin.

6. England pubmed.ncbi.nlm.nih.gov

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] The purpose of this study was to investigate the toxicity and efficacy of the sequential administration of gemcitabine (GMB) in combination with cisplatin (CDDP) followed by docetaxel (Taxotere) as first-line treatment of advanced urothelial carcinoma.

7. England pubmed.ncbi.nlm.nih.gov

Gemcitabine and docetaxel as first-line treatment for advanced urothelial carcinoma: a phase II study. [2022] The purpose of the study was to investigate the toxicity and efficacy of the combination of gemcitabine and docetaxel in untreated advanced urothelial carcinoma. Patients with previously untreated, locally advanced/recurrent or metastatic urothelial carcinoma stage-IV disease were eligible. Patients with Performance status: PS ECOG >3 or age >75 years or creatinine clearance

8. United States pubmed.ncbi.nlm.nih.gov

A phase II study of gemcitabine and docetaxel therapy in patients with advanced urothelial carcinoma. [2022] The objectives of the current study were to evaluate the safety and efficacy of gemcitabine plus docetaxel in patients with unresectable (Stage T4 or >/= N1) metastatic or locally advanced transitional cell carcinoma (TCC) of the urothelial tract.

9. England pubmed.ncbi.nlm.nih.gov

Gemcitabine in the treatment of bladder cancer. [2022] New agents are available for the treatment of metastatic transitional cell carcinoma of the bladder. In the US, the combination of methotrexate, vinblastine, doxorubicin and cisplatin (M-VAC) remains the standard chemotherapy regimen for advanced bladder cancer. Gemcitabine (2',2'-difluorodeoxycytidine [dFdC]) is a relatively new agent with a favourable toxicity profile that has demonstrated activity against a number of solid tumours in both preclinical and clinical studies. Single-agent gemcitabine has shown activity in bladder cancer in both pretreated and chemotherapy-naïve patients. The combination of gemcitabine plus cisplatin is a regimen with significant activity and moderate toxicity in bladder cancer patients. A randomised trial of gemcitabine plus cisplatin versus M-VAC has completed accrual but has not yet been reported. New combination studies of gemcitabine with other chemotherapy agents, including the taxanes, are ongoing.