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Anti-metabolites

Gemcitabine + Docetaxel for Bladder Cancer

Phase 2

Recruiting

Led By Paul Crispen, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Low-grade (Ta) Intermediate risk urothelial carcinoma of the bladder (defined as recurrent low-grade Ta, solitary low-grade Ta > 3 cm, multifocal low-grade Ta)

ECOG Performance Status of 0-2

Must not have

Subjects who have a history of high-grade urothelial carcinoma of the bladder or upper tracts

Prior treatment with intravesical BCG

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months after the start of induction

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study the effectiveness and patient compliance of using a combination of gemcitabine and docetaxel to treat low-grade intermediate-risk bladder cancer. Bladder cancer is common in the

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include irritation in the bladder area, allergic reactions to medications used, blood disorders due to chemotherapy agents like low white blood cell count which increases infection risk, fatigue from treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My bladder cancer is low-grade and either comes back, is larger than 3 cm, or I have more than one tumor.

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I am able to get out of my bed or chair and move around.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of aggressive bladder cancer.

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I have received BCG treatment directly into my bladder.

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My cancer has a neuroendocrine component.

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My cancer is either squamous cell or adenocarcinoma.

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I cannot have a catheter placed due to my anatomy.

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My bladder cannot hold the required volume for certain bladder treatments.

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I have not received a live virus vaccine in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months after start of induction

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months after start of induction

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after start of induction for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recurrence free survival

Secondary study objectives

Progression rate

Treatment compliance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Docetaxel and GemcitabineExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

Gemcitabine

2017

Completed Phase 3

~1920