Gemcitabine + Docetaxel for Bladder Cancer

Overseen By Tian White

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Must not be taking: Live virus vaccines

Disqualifiers: High-grade carcinoma, BCG treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two drugs, gemcitabine and docetaxel (a type of chemotherapy), to determine if they can prevent bladder cancer from returning in patients with low-grade intermediate risk bladder cancer. The drugs are administered directly into the bladder after surgery to prevent recurrence. Suitable candidates for this trial include those with recurring low-grade bladder cancer and no visible signs of the disease when examined with a camera (cystoscopy) within 60 days before joining. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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 there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that using gemcitabine and docetaxel together is generally safe for treating bladder cancer. Previous studies demonstrated good results with few side effects. Patients who received the drugs directly into the bladder usually tolerated them well. Serious side effects were rarely reported, indicating that the treatment is safe for many. This makes it a possible option for those with high- or intermediate-risk bladder cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of gemcitabine and docetaxel for bladder cancer because it offers a dual-action approach that might enhance treatment effectiveness. Unlike the standard chemotherapy regimens that typically use drugs like cisplatin, this combination targets cancer cells in two ways, potentially increasing the chance of eliminating the cancer. Additionally, the treatment is given in two phases: an induction phase for an immediate impact and a maintenance phase to sustain long-term control, which could lead to better outcomes for patients. This innovative strategy could provide a new hope for those who do not respond well to current therapies.

What evidence suggests that this treatment might be an effective treatment for bladder cancer?

Research has shown that using gemcitabine and docetaxel together may help treat bladder cancer. In this trial, all participants will receive this combination treatment. One study found that 71% of patients who received this combination did not experience cancer recurrence within two years. For those without prior treatments, this rate increased to 79%. Another study found that this treatment led to fewer cases of severe cancer recurrence compared to the standard BCG treatment. Most participants tolerated this approach well, with manageable and non-severe side effects. These findings suggest that gemcitabine and docetaxel might effectively reduce bladder cancer recurrence. ^{1 3 6 7 8}

Who Is on the Research Team?

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

Exclusion Criteria

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

I have received BCG treatment directly into my bladder.

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?

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

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

The sequential treatment of gemcitabine and cisplatin followed by docetaxel showed a promising objective response rate of 55.2% in 38 patients with advanced urothelial carcinoma, indicating its efficacy as a first-line therapy.

The treatment was generally well tolerated, with manageable side effects; although 27% experienced severe neutropenia during the GP regimen, there were no toxic deaths reported, suggesting a favorable safety profile.

NCBI (Pubmed)

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. Boukovinas, I., Androulakis, N., Vamvakas, L., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 27 patients with unresectable metastatic or locally advanced transitional cell carcinoma, the combination of gemcitabine and docetaxel showed a 33.3% objective clinical response rate, with a median survival duration of 52 weeks.

The treatment was generally well tolerated, with neutropenia being the most common severe side effect, indicating that this combination therapy could be a viable option for patients who cannot receive cisplatin due to renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of gemcitabine and docetaxel therapy in patients with advanced urothelial carcinoma. Gitlitz, BJ., Baker, C., Chapman, Y., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The combination of gemcitabine and docetaxel showed a 51.6% overall response rate in 31 patients with advanced urothelial carcinoma, indicating significant efficacy as a first-line treatment.

The treatment was well tolerated, with manageable hematologic toxicities and no toxic deaths, suggesting it could be a safer alternative for patients with compromised renal function or cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine and docetaxel as first-line treatment for advanced urothelial carcinoma: a phase II study. Ardavanis, A., Tryfonopoulos, D., Alexopoulos, A., et al.[2022]

Gemcitabine, a newer chemotherapy agent, has shown promising activity against bladder cancer, both as a single agent and in combination with cisplatin, offering a favorable toxicity profile compared to traditional treatments.

The standard treatment for advanced bladder cancer in the US remains the M-VAC regimen, but ongoing trials are exploring the effectiveness of gemcitabine combined with other agents, which may lead to improved treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine in the treatment of bladder cancer. Ryan, CW., Vogelzang, NJ.[2022]

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.

NCBI (Pubmed)

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. Dreicer, R., Manola, J., Schneider, DJ., et al.[2022]

In a study of 35 patients with advanced transitional cell carcinoma (TCC), a combination of weekly docetaxel, gemcitabine, and cisplatin resulted in a high objective response rate of 65.6%, with 28.5% achieving a complete response.

The treatment was associated with moderate toxicity, including grade 3/4 neutropenia in 28.5% of patients, but no treatment-related deaths occurred, suggesting it is a safe and effective option for chemotherapy-naïve patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weekly chemotherapy with docetaxel, gemcitabine and cisplatin in advanced transitional cell urothelial cancer: a phase II trial. Pectasides, D., Glotsos, J., Bountouroglou, N., et al.[2022]

The combination of docetaxel and gemcitabine offers a promising second-line treatment option for patients with non-muscle-invasive bladder cancer that does not respond to bacillus Calmette-Guérin therapy.

Both drugs are well tolerated as individual treatments and have different mechanisms of action, making their combination a potentially effective and affordable standard of care.

NCBI (Pubmed)

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. Roumiguié, M., Black, PC.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39797535/

Gemcitabine and docetaxel for high-risk non-muscle- ... The intravesical Gem/Doce regimen demonstrated promising short-term oncological outcomes and was well tolerated in this cohort of patients with high- and very- ...

2. urotoday.com urotoday.com/conference-highlights/wsaua-2025/wsaua-2025-bladder-cancer/164434-wsaua-2025-comparative-effectiveness-of-intravesical-gemcitabine-versus-sequential-gemcitabine-and-docetaxel-for-high-risk-nmibc.html

WSAUA 2025: Comparative Effectiveness of Intravesical ... Low-grade adverse events were common: 63% of gemcitabine and 55% of gemcitabine and docetaxel patients reported any adverse event (p = 0.19), while grade ≥3 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429525000068

A Comparison Between Intravesical Gemcitabine Plus ... This study evaluated the efficacy, recurrence rates, and safety of intravesical gemcitabine plus docetaxel compared to standard Bacillus Calmette-Guérin (BCG) ...

4. uroweb.org uroweb.org/news/eau-oncology-section-perspective-gemcitabine-docetaxel-a-new-option-for-european-centres-in-the-management-of-nmibc

EAU Oncology Section perspective: Gemcitabine/docetaxel McElree et al. reported a 2-year RFS of 71%, with significantly better outcomes among treatment-naïve patients (79%) compared to those ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2801788

Gemcitabine and Docetaxel vs Bacillus Calmette Guérin for ... Conclusions and Relevance In this cohort study, gemcitabine and docetaxel therapy was associated with less high-grade disease recurrence and ...

6. urotoday.com urotoday.com/conference-highlights/aua-2025/aua-2025-bladder-cancer/159954-aua-2025-intravesical-gemcitabine-and-docetaxel-for-high-risk-non-muscle-invasive-bladder-cancer-previously-treated-with-bcg-results-from-the-eurogemdoce-group.html

Intravesical Gemcitabine and Docetaxel for High-Risk Non- ... The aim of the study was to report the oncologic and safety outcomes of Gem/Doce in a European multicenter cohort of NMIBC patients.

7. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.16716?af=R

Assessing the efficacy and safety of sequential intravesical ... Sequential intravesical gemcitabine and docetaxel (Gem/Doce), has emerged as a promising alternative to BCG for both high- and intermediate-risk ...

8. urologytimes.com urologytimes.com/view/intravesical-gemcitabine-docetaxel-formulation-shows-encouraging-efficacy-in-hg-nmibc

Intravesical gemcitabine/docetaxel formulation shows ... Overall, data showed a complete response (CR) rate at any time point of 91% (21 of 23). At 3- and 6-months, the CR rates were 83% (19 of 23) and ...