Gemcitabine + Docetaxel for Bladder Cancer

Overseen By Mohamad Abou Chakra, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Michael A. O'Donnell

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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn whether a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can treat high-grade non-muscle-invasive bladder cancer (HG-NMIBC) in adults whose cancer failed conventional BCG therapy. The drugs are given directly into the bladder (intravesically), one immediately after the other.

The study will also assess the safety of this treatment.

The main questions it aims to answer are:

Can this drug combination effectively treat HG-NMIBC that did not respond to BCG and help prevent the cancer from coming back, offering long-term protection? What side effects or medical issues do participants experience during treatment?

Researchers will evaluate this non-surgical approach as a potential alternative to bladder removal surgery (radical cystectomy), with the goal of validating it as a bladder-sparing option in this setting.

Participants will:

* Go through a screening process, including tumor removal and imaging tests

* Receive weekly bladder treatments with Gemcitabine followed by Docetaxel for 6 weeks

* If the cancer responds, continue with similar once monthly treatments (maintenance therapy) for up to 2 years

* Attend regular check-ups, including bladder exams, urine tests, biopsies, and optional quality-of-life surveys

* Possibly receive a second 6-week treatment cycle if the cancer returns early

* Be followed for up to 5 years to monitor long-term outcomes

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

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