Bladder CancerPhase 2NCT06488222
Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer
A Phase 2 study testing Docetaxel and Gemcitabine in people with Bladder Cancer, run by University of Florida at 1 site in United States.
Trial summary
Bladder cancer is the 8th most common cancer in the UF Health Cancer Center catchment area and the 7th most common cancer presenting to UFHealth. Most newly diagnosed cases are stage I bladder cancer, which is defined by having no deep muscle invasion and no evidence of disease beyond the bladder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Docetaxel and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32608
Karine Charles, 352-294-5018, kmcharles@ufl.edu
About this study
Bladder cancer is the 8th most common cancer in the UF Health Cancer Center catchment area and the 7th most common cancer presenting to UFHealth. Most newly diagnosed cases are stage I bladder cancer, which is defined by having no deep muscle invasion and no evidence of disease beyond the bladder. The current use in BCG (Bacillus Calmette-Guerin) refractory disease and the ongoing evaluation in BCG naïve high-risk disease support evaluation of intravesical gemcitabine and docetaxel in decreasing disease recurrence in intermediate risk stage I bladder cancer.
This study will investigate the efficacy and subject compliance with treatment of low grade intermediate risk bladder cancer with intravesical gemcitabine and docetaxel.
- Conditions
- Bladder Cancer
- Being tested
- Docetaxel, Gemcitabine
- Keywords
- bladder cancer, transurethral resection, gemcitabine, docetaxel
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Subjects will receive 40 mg docetaxel intravesically.
GemcitabineDrug
Subjects will receive 1 mg gemcitabine intravesically.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel and Gemcitabine | Experimental | 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. Receives: Drug: Docetaxel; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival
Evaluate the recurrence free survival, as measured by cystoscopy
Measured: 12 months after start of induction
Secondary outcomes (2)
Progression rate
Determine the progression rate at 12 months, for tumor grade and stage, based on pathologic assessment of tumors in patients with disease recurrence. Development of the following will be considered progression: high grade disease, ≥ T1 disease, CIS.
Measured: 12 months after start of induction
Treatment compliance
Determine treatment compliance, as measured by how many planned study treatments were given. This will be measured by documented administration of study treatments in the subject's medical record.
Measured: 12 months after the start of induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start5 Nov 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Crispen, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488222
- Sponsor's protocol ID
- UF-GU-010
- Other IDs
- OCR45548, IRB202401256
- Status last verified
- Mar 2026
- First submitted
- 21 Jun 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer
- ClinicalTrials.gov ID
- NCT06488222
- Acronym / sponsor ID
- UF-GU-010
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, transurethral resection, gemcitabine, docetaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bladder cancer is the 8th most common cancer in the UF Health Cancer Center catchment area and the 7th most common cancer presenting to UFHealth. Most newly diagnosed cases are stage I bladder cancer, which is defined by having no deep muscle invasion and no evidence of disease beyond the bladder. The current use in BCG (Bacillus Calmette-Guerin) refractory disease and the ongoing evaluation in BCG naïve high-risk disease support evaluation of intravesical gemcitabine and docetaxel in decreasing disease recurrence in intermediate risk stage I bladder cancer.
This study will investigate the efficacy and subject compliance with treatment of low grade intermediate risk bladder cancer with intravesical gemcitabine and docetaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel and Gemcitabine | Experimental | Drug: Docetaxel, Drug: GemcitabineAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelSubjects will receive 40 mg docetaxel intravesically. | Drug | Docetaxel and Gemcitabine |
| GemcitabineSubjects will receive 1 mg gemcitabine intravesically. | Drug | Docetaxel and Gemcitabine |
Primary outcome
Recurrence free survival
Time frame: 12 months after start of induction
Evaluate the recurrence free survival, as measured by cystoscopy
2 secondary outcomes
Progression rate
Time frame: 12 months after start of induction
Treatment compliance
Time frame: 12 months after the start of induction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Crispen, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Gemcitabine in people with Bladder Cancer, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karine Charles (352-294-5018, kmcharles@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence free survival (time frame: 12 months after start of induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.