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New treatment option for Bladder Cancer
Official title Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer
ClinicalTrials.gov ID: NCT06488222
What this study is testing
What is Docetaxel?
Docetaxel is an investigational medicine, being studied as a potential treatment for bladder cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- people 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.
See the full eligibility criteria
- 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
- people with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen [as determined by...
- people 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...
- people 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...
- Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.
- people 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.
- people 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.
- people 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...
- 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...
- Prisoners or people who are involuntarily incarcerated, or people who are compulsorily detained for treatment of either a psychiatric or physical illness.
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.