Gemcitabine + Docetaxel for Bladder Cancer

Overseen By Mohamad Abou Chakra, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Michael A. O'Donnell

Must not be taking: Checkpoint inhibitors

Disqualifiers: Stage T2 cancer, Upper tract cancer, Variant histology, Active malignancies, Severe hypersensitivity, 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: 31

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can treat high-grade non-muscle-invasive bladder cancer unresponsive to standard BCG therapy. The treatment involves delivering these drugs directly into the bladder to determine if this approach can provide effective and long-lasting cancer control without requiring bladder removal surgery. The trial also evaluates the treatment's safety and any side effects. Suitable candidates for this trial have high-grade bladder cancer that hasn't spread and have not benefited from previous BCG treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial requires a washout period (time without taking certain medications) of 8 weeks for any intravesical or systemic chemotherapeutic agents before joining. If you are on other medications, the protocol does not specify, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that administering Gemcitabine and Docetaxel directly in the bladder is generally safe for patients with high-risk non-muscle-invasive bladder cancer. Earlier research demonstrated good short-term results, with patients tolerating the treatment well. Most did not experience severe side effects. Common side effects were mild, such as discomfort during treatment, and serious issues were rare. Researchers are studying this treatment because it might help people avoid more invasive procedures like bladder removal surgery. While more research is ongoing, current findings suggest the treatment is safe for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Gemcitabine and Docetaxel for treating high-grade non-muscle-invasive bladder cancer (HG NMIBC) because they may offer a fresh approach compared to the standard treatments like Bacillus Calmette-Guérin (BCG) therapy. While BCG works by stimulating the immune system to fight cancer cells, Gemcitabine and Docetaxel are chemotherapeutic agents that directly target and kill rapidly dividing cancer cells, potentially providing a more aggressive attack on the tumors. This combination could be particularly promising for patients who have not responded well to traditional therapies, offering new hope for better outcomes.

What evidence suggests that this trial's treatments could be effective for high-grade non-muscle-invasive bladder cancer?

Research has shown that combining gemcitabine and docetaxel may help treat high-risk bladder cancer that hasn't invaded the muscle, particularly when the usual BCG treatment fails. In this trial, researchers will assign participants to different treatment arms based on their specific cancer characteristics. Studies have indicated that about 50-60% of patients remained cancer-free a year after receiving gemcitabine and docetaxel, suggesting a good chance the cancer won't return within that time. Additionally, most patients manage the side effects well. For those considering this option, the evidence offers hope for a treatment that might avoid more invasive procedures like bladder removal. ^{1 3 6 7 8}

Who Is on the Research Team?

Michael A O'Donnell, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for adults with high-grade non-muscle-invasive bladder cancer (HG-NMIBC) that hasn't improved after BCG therapy. Participants must have had tumor removal and imaging tests, be able to receive treatments directly into the bladder, and commit to regular check-ups and possible long-term follow-up.

Inclusion Criteria

My recent scans of the upper urinary tract are normal and my prostate looks normal.

Women of childbearing potential must have a negative pregnancy test at screening

All patients of childbearing potential must be willing to consent to using effective contraception while on treatment and for 3 months after their last Gemcitabine/Docetaxel treatment

Exclusion Criteria

Participation in any other research protocol involving administration of an investigational agent within 6 weeks of study entry

I have not had COVID-19 or shown symptoms in the last 30 days.

Significant cardiovascular risk

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Induction Treatment

Participants receive weekly bladder treatments with Gemcitabine followed by Docetaxel for 6 weeks

6 weeks

6 visits (in-person)

Maintenance Treatment

If the cancer responds, participants continue with similar once monthly treatments for up to 2 years

24 months

24 visits (in-person)

Follow-up

Participants are monitored for long-term outcomes, including safety and effectiveness, for up to 5 years

60 months

Regular check-ups including bladder exams, urine tests, and biopsies

What Are the Treatments Tested in This Trial?

Interventions

• Docetaxel
• Gemcitabine

Trial Overview

The trial studies a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, administered intravesically as an alternative to surgery. It aims to see if this treatment can effectively manage HG-NMIBC post-BCG failure by preventing recurrence and offering long-term protection.

How Is the Trial Designed?

Group I: Arm B Experimental Treatment 1 Intervention

High-grade non-muscle-invasive bladder cancer (HG NMIBC) with high-grade papillary tumors (stages Ta and/or T1) without carcinoma in situ (CIS).

Group II: Arm A Experimental Treatment 1 Intervention

High-grade non-muscle-invasive bladder cancer (HG NMIBC) with carcinoma in situ (CIS), either as pure CIS or concurrent with papillary tumors.

Who Is Running the Clinical Trial?

Michael A. O'Donnell

Lead Sponsor

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 ...

2.

urotoday.com

urotoday.com/conference-highlights/aua-2025/aua-2025-bladder-cancer/160107-aua-2025-prospective-open-label-study-to-evaluate-the-safety-and-efficacy-of-intravesical-sustained-release-gemcitabine-docetaxel-combination-ndv-01-in-high-risk-nmibc.html

AUA 2025: Prospective Open Label Study to Evaluate ...

Gemcitabine + docetaxel has shown a 50-60% 12 month recurrence free survival in BCG unresponsive high risk non muscle invasive bladder cancer, ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07322263?locStr=United+States&country=United+States

Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC

The primary objective of this study is to evaluate the efficacy of intravesical sequential Gemcitabine and Docetaxel in patients with BCG- ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1078143924001765

122 oncologic outcomes of gemcitabine-docetaxel ...

In a large multi-center cohort of BCG-unresponsive NMIBC patients, BST treatment with Gem/Doce does not appear to significantly compromise oncologic outcomes.

5.

urologytimes.com

urologytimes.com/view/data-supports-combination-intravesical-chemotherapy-for-high-risk-nmibc

Data support combination intravesical chemotherapy for ...

Sequential valrubicin and docetaxel therapy showed efficacy in recurrent high-risk NMIBC, with 45% of patients disease-free at two years. High- ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07322263?cond=cancer

Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC

The primary objective of this study is to evaluate the efficacy of intravesical sequential Gemcitabine and Docetaxel in patients with BCG- ...

7.

bjui-journals.onlinelibrary.wiley.com

bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.16645

Gemcitabine and docetaxel for high‐risk non‐muscle‐invasive ...

Our study is the first evaluation of the oncological outcomes and AEs associated with sequential intravesical Gem/Doce therapy in patients with high- and very- ...

8.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.703

Intravesical gemcitabine and docetaxel combined with ...

These results suggest that intravesical GemDoce with intravenous tislelizumab is an effective and tolerable treatment option for patients with HR NMIBC.