Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer

This study is looking at a new way to treat low-grade intermediate-risk bladder cancer. Researchers are testing two drugs, gemcitabine and docetaxel, which are given directly into the bladder (intravesically). This treatment aims to reduce how often bladder cancer comes back. You might be able to join if you are an adult aged 18 or older with this specific type of bladder cancer, and your cancer has not spread to the upper urinary tract. The main goal is to see how long people stay cancer-free after treatment, specifically for 12 months. The study plans to enroll 34 participants, but its current status is unclear.

Study design: This is an interventional study with a planned enrollment of 34 participants. The study will investigate the effectiveness of gemcitabine and docetaxel.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed to measure recurrence-free survival at 12 months after starting the induction treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer

Recruiting

PHASE2Ages 18+InterventionalTreatment

University of Florida

~34 participants

Updated 2026-03-11 on ClinicalTrials.gov

What's tested:DocetaxelGemcitabine

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Recurrence free survival

Measured over 12 months after start of induction

Conditions

Bladder Cancer

NCT06488222

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

University of Florida
Gainesville, Floridastudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Paul Crispen, MD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Karine Charles

[email protected]

352-294-5018

Email the study team

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Eligibility criteria

Inclusion

Adults ≥ 18 years of age.

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). Up to 10% high grade component is allowed.

ECOG Performance Status of 0-2.

No evidence of upper tract urothelial carcinoma based on CT, MRI, or retrograde pyelograms.

No urethral involvement based on cystoscopy.

No visible disease based on cystoscopy within 60 days of study enrollment.

Neutrophil counts ≥ 1500 cells/mm3

Platelet counts \>100,000 cells/mm3

Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician or approved by the PI\] may be included.

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.

Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 3 months following the last dose of study drug.

Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.

Exclusion

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

Prior treatment with intravesical BCG

Pure squamous cell carcinoma or adenocarcinoma

Any component of neuroendocrine carcinoma

Anatomic abnormalities that prohibit urethral catheter placement

Low bladder capacity (determined by the treating Urologist) which prohibits treatment with intravesical therapy.

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.

History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.

Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose.

Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

What this trial measures

Recurrence free survival12 months after start of induction
Evaluate the recurrence free survival, as measured by cystoscopy

Trialytics