Actively Recruiting
Phase II Trial of Intravesical Gemcitabine + Docetaxel for Nonmuscle Invasive Bladder Cancer With or Without Prior BCG Therapy
Led by University of Arizona · Updated on 2026-02-27
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of intravesical chemotherapy combining Gemcitabine and Docetaxel for patients with intermediate or high-risk non-muscle invasive bladder cancer (NMIBC), including those with or without prior Bacillus Calmette-Gu E9rin (BCG) therapy. This phase II trial aims to better understand the role of Gemcitabine plus Docetaxel as a first-line treatment option, especially given the limited effective alternatives following BCG failure and recent BCG shortages. Participants will receive weekly treatments of Gemcitabine and Docetaxel administered directly into the bladder once a week for six weeks. The drugs are given intravesically at doses of 1000 mg for Gemcitabine and 40 mg for Docetaxel. The treatment focuses on patients who have either not received BCG before or have had a high-grade recurrence after previous BCG therapy. During the study, participants will be monitored regularly, with a key measurement being the complete response rate assessed at three months. Researchers will also evaluate how long any response lasts up to twelve months, treatment safety and tolerability, acceptance of maintenance therapy, and the frequency and reasons for bladder removal surgery (cystectomy). Assessments will include clinical exams and toxicity evaluations throughout approximately one year of follow-up.
CONDITIONS
Brief Title
Intravesical Gem/Doce in Patients With NMIBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to consent in English or Spanish and provide signed informed consent
- Willing to follow all study procedures and available for study duration
- Male or female aged 18 years or older
- Patients with intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder with no previous BCG treatment
- Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma (Ta, T1, or Tis stage) within 180 days before registration, or high-grade recurrence after 24 months since last BCG dose
- ECOG performance status Grade 0-2
- Post-transurethral bladder tumor resection
- Post-menopausal status or negative pregnancy test for pre-menopausal women
You will not qualify if you...
- Known allergy to gemcitabine and/or docetaxel
- Clinical T2 or higher stage urothelial carcinoma of the bladder
- Histopathology showing small cell, pure adenocarcinoma, pure squamous cell carcinoma, or pure carcinoma in situ of the bladder
- Active cancers other than bladder cancer being treated
- Concurrent upper urinary tract urothelial carcinoma at any stage
- Pregnant or breastfeeding women
- Substance abuse or psychiatric disorder preventing study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 weeks
Participants receive intravesical gemcitabine and docetaxel once weekly.
6 weekly visits (in-person)
Duration - Up to 12 months
Participants are monitored to assess treatment response and safety, including evaluation at 3 months and up to 12 months after treatment initiation.
Visits at 3 months and periodic assessments up to 12 months
Trial Site Locations
Total: 1 location
1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85721
Actively Recruiting
Research Team
J
Juan Chipollini, MD
M
Michele Chu-Pilli
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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