Actively Recruiting
Intravesical Gem/Doce in Patients With NMIBC
Led by University of Arizona · Updated on 2026-02-27
25
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Intravesical immunotherapy or chemotherapy for non-muscle invasive bladder cancer (NMIBC) is a well-established treatment for preventing or delaying tumor recurrence after tumor resection. For high-risk non-muscle invasive bladder cancer, immunotherapy in the form of intravesical Bacillus Calmette-Guérin (BCG) can be effective as first-line; nevertheless, the response rate to BCG is suboptimal with many patients failing treatment. Following BCG-failure, however, very few effective therapeutic options exist besides life-changing cystectomy. Recent shortages of BCG have pushed the use of alternative intravesical therapies for non-muscle invasive bladder cancer. At the University of Arizona Cancer Center, the use of intravesical Gemcitabine + Docetaxel (Gem/Doce) is considered as standard treatment for patients with non-invasive bladder cancer who are unable to get BCG or are BCG-resistant. The role of Gemcitabine as first-line treatment for NMIBC is poorly understood. The purpose of this study is to gain a better understanding of the use of Gemcitabine + Docetaxel intravesical chemotherapy for non-muscle invasive bladder cancer.
CONDITIONS
Official Title
Intravesical Gem/Doce in Patients With NMIBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give consent in English or Spanish and willing to comply with all study procedures
- Male or female aged 18 years or older
- Diagnosed with intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) confirmed by biopsy within 180 days prior to registration, or high-grade recurrence after 24 months since last BCG
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Completed transurethral resection of bladder tumor (TURBT)
- Evidence of post-menopausal status or negative pregnancy test in pre-menopausal women
You will not qualify if you...
- Known allergic reaction to gemcitabine or docetaxel
- Clinical bladder cancer stage T2 or higher
- Bladder cancer with small cell, pure adenocarcinoma, pure squamous cell carcinoma, or pure carcinoma in situ (CIS) components
- Active cancers other than the one being treated in this study
- Concurrent urothelial carcinoma in upper urinary tract (ureter or renal pelvis) of any stage
- Pregnant or breastfeeding women
- Substance abuse or psychiatric disorders that would prevent following the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
M
Michele Chu-Pilli
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here