Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06488222
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    Subjects will receive 40 mg docetaxel intravesically.
  • Gemcitabine — DRUG
    Subjects will receive 1 mg gemcitabine intravesically.

Study Details

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.

Key Dates

Start date
Nov 5, 2024
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Docetaxel and Gemcitabine
    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.

Primary Outcome Measure

Recurrence free survival [ Time Frame: 12 months after start of induction ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32608
Karine Charles
[email protected]
352-294-5018

Find similar trials in Gainesville, FL

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
University of Florida· Gainesville, FL

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