Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer

NCT06488222 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: UF-GU-010OCR45548IRB202401256
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

bladder cancer; transurethral resection; gemcitabine; docetaxel

Outcome Measures

Primary Outcomes (1)

• Recurrence free survival

  Evaluate the recurrence free survival, as measured by cystoscopy

  12 months after start of induction

Secondary Outcomes (2)

• Progression rate

  12 months after start of induction

• Treatment compliance

  12 months after the start of induction

Study Arms (1)

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.

Drug: Docetaxel; Drug: Gemcitabine

Interventions

Gemcitabine DRUG

Subjects will receive 1 mg gemcitabine intravesically.

Docetaxel and Gemcitabine

Docetaxel DRUG

Subjects will receive 40 mg docetaxel intravesically.

Docetaxel and Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Docetaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Paul Crispen, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karine Charles

CONTACT

352-294-5018; kmcharles@ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 5, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)