In-home Chemotherapy for Bladder Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Mayo Clinic

Must be taking: Gemcitabine, Bacillus Calmette-Guerin

Must not be taking: Investigational agents

Disqualifiers: Active infection, Heart failure, others

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

Compensation: Varies

Number of Visits: 5

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether chemotherapy for non-muscle invasive bladder cancer can be safely and effectively administered at home instead of in a clinic. It focuses on treatments that deliver drugs like BCG, gemcitabine, docetaxel, and mitomycin directly into the bladder using a catheter. The goal is to determine if this method is safe, tolerable, and less disruptive for patients who manage frequent clinic visits. Individuals with non-muscle invasive bladder cancer already undergoing specific chemotherapy regimens may be eligible. Those dealing with this type of bladder cancer and seeking in-home treatment options might find this trial suitable. As a Phase 1, Phase 2 trial, the research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are receiving other treatments for bladder cancer that are not part of the eligible regimens.

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

Research shows that the chemotherapy drugs under study for home treatment—docetaxel, gemcitabine, and mitomycin—have been safely used in various cancer treatments.

Studies have safely administered docetaxel to patients with bladder cancer. It is also approved for treating other cancers, such as prostate cancer. However, it can cause side effects like low white blood cell counts and allergic reactions.

Gemcitabine is approved for bladder cancer and has been shown to help reduce cancer recurrence when used in the bladder. It is generally well-tolerated, but extra care is needed if the bladder is damaged.

Mitomycin is used for several cancers, including bladder cancer. Some patients may experience bladder irritation or discomfort, but these side effects can be managed.

Overall, these treatments have been studied and used in different settings, demonstrating their safe administration. This trial is in the early stages and focuses on assessing the safety and tolerability of these treatments when given at home. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard in-clinic treatments for bladder cancer, this in-home chemotherapy approach is unique because it allows patients to receive treatment in the comfort of their own homes. Researchers are excited about this treatment because it uses intravesical delivery, where medications like BCG, gemcitabine, docetaxel, and mitomycin are delivered directly into the bladder. This method not only targets cancer cells more directly but also minimizes the systemic side effects that come with traditional chemotherapy. Additionally, the convenience of at-home administration can improve patient quality of life and adherence to treatment schedules, potentially leading to better outcomes.

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

This trial will evaluate the effectiveness of different chemotherapy treatments for bladder cancer. Research has shown that using gemcitabine and mitomycin C directly in the bladder can greatly reduce the chance of tumors returning in non-muscle invasive bladder cancer. In this trial, participants may receive gemcitabine combined with docetaxel, which has shown promising results; specifically, 65% of patients who did not respond to the standard BCG treatment remained cancer-free for one year. Alternatively, participants may receive mitomycin C alone, which also significantly reduces the risk of tumor recurrence. Furthermore, studies indicate that using these drugs together can lead to 46% of patients being cancer-free for two years. This evidence supports the potential effectiveness of these chemotherapy treatments in managing bladder cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Timothy D. Lyon, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients with non-muscle invasive bladder cancer. It's designed to test if chemotherapy at home is as safe and tolerable as treatment in a clinic. Participants should be comfortable receiving treatments through a catheter into the bladder and completing questionnaires.

Inclusion Criteria

Residing within the area serviced by supplier network

Residence has Wi-Fi or cellular data network connection for virtual telehealth visits

Signed informed consent form by patient or the patient's legally authorized representative

Exclusion Criteria

Receiving any other investigational or standard of care agent not part of the eligible treatment regimens for non-muscle invasive bladder cancer

Current inpatient hospitalization excluding admission to the Advanced Care at Home program

Known allergy or previous intolerance to drug regimens

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Patients receive intravesical chemotherapy in the urology clinic and at home once weekly for up to 5 weeks

5 weeks

5 visits (in-home)

Maintenance

Patients receive in-home intravesical therapy once weekly for 3 weeks or once monthly for 3 months depending on the drug regimen

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Docetaxel
• Gemcitabine
• Mitomycin

Trial Overview The INVITE trial compares at-home versus in-clinic intravesical chemotherapy using drugs like BCG, gemcitabine, docetaxel, and mitomycin C. The study aims to see if home treatment can reduce life disruption for patients while being safe.

How Is the Trial Designed?

Group I: Treatment (BCG, gemcitabine, docetaxel, mitomycin) Experimental Treatment 7 Interventions

INDUCTION (PHASE IB COHORT AND PHASE II COHORT): Patients receive BCG intravesically over 1-2 hours, gemcitabine intravesically over 1-2 hours, gemcitabine intravesically over 1 hour followed by docetaxel intravesically over 1 hour or mitomycin C intravesically over 1-2 hours in the urology clinic. Treatment repeats once weekly in the home for up to 5 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE (PHASE II COHORT ONLY): Patients receive in-home BCG intravesically over 1-2 hours once weekly for 3 weeks, gemcitabine intravesically over 1-2 hours once monthly for 3 months, gemcitabine intravesically over 1 hour followed by docetaxel intravesically over 1 hour once monthly for 3 months or mitomycin C intravesically over 1-2 hours once monthly for 3 months in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo cystoscopy at end of study and receive access to CCBW home health visits throughout the study.

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?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

Current treatments for muscle-invasive bladder cancer, including radical cystectomy and chemotherapy, have a cure rate of only about 50%, with many patients developing metastases within two years.

New agents like taxanes (paclitaxel and docetaxel) and gemcitabine show promising results in preliminary phase II studies, suggesting they could enhance treatment outcomes when combined with existing chemotherapy regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of new drugs in the treatment of locally advanced urothelial tumors of the bladder]. Antoine, EC., Khayat, D.[2022]

In a randomized phase III trial involving 220 patients with inoperable or metastatic urothelial carcinoma, the MVAC regimen demonstrated superior response rates (54.2% vs. 37.4%) and longer median time to progression (9.4 months vs. 6.1 months) compared to the docetaxel and cisplatin (DC) combination.

While MVAC was more effective, it also resulted in higher rates of severe side effects, such as neutropenia and neutropenic sepsis, although the toxicity was lower than previously reported for MVAC without G-CSF support, suggesting that G-CSF makes MVAC a safer option for first-line treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Docetaxel and cisplatin with granulocyte colony-stimulating factor (G-CSF) versus MVAC with G-CSF in advanced urothelial carcinoma: a multicenter, randomized, phase III study from the Hellenic Cooperative Oncology Group. Bamias, A., Aravantinos, G., Deliveliotis, C., et al.[2018]

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 study of 277 patients with muscle-invasive bladder cancer or locally advanced upper tract urothelial cancer, both high dose-intensity combination chemotherapy (HD MVAC) and gemcitabine plus cisplatin (GC) showed similar oncologic outcomes, with no significant differences in pathologic complete response rates or overall survival after 3 years.

However, HD MVAC was associated with a higher risk of febrile neutropenia compared to GC, indicating that while both treatments are effective, HD MVAC may pose additional safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of clinical outcomes in patients with localized or locally advanced urothelial carcinoma treated with neoadjuvant chemotherapy involving gemcitabine-cisplatin and high dose-intensity MVAC. Lee, Y., Kim, YS., Hong, B., 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11674742/

Comparisons of Intravesical Treatments with Mitomycin C, ... Compared to other treatments, both gemcitabine and mitomycin C showed statistically significant risk reductions of 24% and 37% for tumor ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1078143925001243

Intravesical gemcitabine and docetaxel in patients with ... The overall 1-year HG recurrence-free survival was 65% (95% CI: 59–71), and in patients with BCG-unresponsive CIS, this was 60% (95% CI: 47–71). These ...

3. ascopubs.org ascopubs.org/doi/10.1200/EDBK-25-471942

New Treatment Options for Non–Muscle-Invasive Bladder ... The treatment achieved a 2-year recurrence-free survival (RFS) rate of 46% and a HG RFS rate of 52%, with a 50% HG-RFS specifically in patients ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39766024/

Updated Systematic Review and Meta-Analysis We conducted an updated meta-analysis of studies that evaluated the efficacy of and outcomes after treatment with mitomycin C (MMC), gemcitabine ...

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. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2013/020449s071lbl.pdf

Taxotere (docetaxel) Label - accessdata.fda.gov WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA,. HYPERSENSITIVITY REACTIONS, and FLUID RETENTION. See full prescribing information for complete boxed ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK537242/

Docetaxel - StatPearls - NCBI Bookshelf - NIH Docetaxel, in combination with cisplatin, is approved by the Federal Drug Agency (FDA) as a first-line treatment for prostate cancer.

8. products.sanofi.us products.sanofi.us/taxotere/taxotere.html

TAXOTERE® (docetaxel) injection, for intravenous use Table 11 summarizes the safety data obtained from patients that received induction chemotherapy with TAXOTERE 75 mg/m2 in combination with cisplatin and ...

9. cancernetwork.com cancernetwork.com/view/docetaxel-management-advanced-or-metastatic-urothelial-tract-cancer

Docetaxel in the Management of Advanced or Metastatic ... The authors concluded that docetaxel can be safely and effectively administered to metastatic urothelial cancer patients with impaired renal function.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT03209206

The Effectiveness and Safety of Intravesical Docetaxel ... Indeed, a single early instillation of Docetaxel was found to reduce the post-TURBT bladder recurrence rate among patients with bladder cancer. In this ...