Actively Recruiting
Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC
Led by Michael A. O'Donnell · Updated on 2026-04-17
174
Participants Needed
1
Research Sites
351 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn whether a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can treat high-grade non-muscle-invasive bladder cancer (HG-NMIBC) in adults whose cancer failed conventional BCG therapy. The drugs are given directly into the bladder (intravesically), one immediately after the other. The study will also assess the safety of this treatment. The main questions it aims to answer are: Can this drug combination effectively treat HG-NMIBC that did not respond to BCG and help prevent the cancer from coming back, offering long-term protection? What side effects or medical issues do participants experience during treatment? Researchers will evaluate this non-surgical approach as a potential alternative to bladder removal surgery (radical cystectomy), with the goal of validating it as a bladder-sparing option in this setting. Participants will: * Go through a screening process, including tumor removal and imaging tests * Receive weekly bladder treatments with Gemcitabine followed by Docetaxel for 6 weeks * If the cancer responds, continue with similar once monthly treatments (maintenance therapy) for up to 2 years * Attend regular check-ups, including bladder exams, urine tests, biopsies, and optional quality-of-life surveys * Possibly receive a second 6-week treatment cycle if the cancer returns early * Be followed for up to 5 years to monitor long-term outcomes
CONDITIONS
Official Title
Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged over 18 years able to read, understand, and sign informed consent
- Histologically confirmed urothelial carcinoma of the bladder without upper tract or prostatic urethral involvement
- Diagnosed with either carcinoma in situ (CIS) with or without Ta/T1 tumors or high-grade papillary tumors (Ta/T1) without CIS
- Complete resection of all visible bladder tumors within 8 weeks before starting treatment
- Confirmed BCG-unresponsive disease based on FDA criteria including prior adequate BCG therapy
- Eligible for radical cystectomy but declined or not a surgical candidate due to other health conditions
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during and 3 months after treatment
- No intravesical or upper tract therapy within 8 weeks prior to enrollment
- Willing and able to comply with all study procedures
- Complete Blood Count within 30 days before tumor resection or 14 days before treatment start
- At least 8 weeks since last intravesical therapy or two dosing intervals since last systemic immune therapy
You will not qualify if you...
- History or current stage T2 or higher urothelial cancer
- History or presence of upper tract or prostatic urethral cancer
- Variant bladder cancer histology except favorable micropapillary urothelial carcinoma
- Active malignancies other than well-controlled prostate, basal/squamous skin, or non-invasive cervical cancers
- Severe hypersensitivity to Gemcitabine, Docetaxel, or Polysorbate 80 containing drugs
- Concurrent intravesical or systemic chemotherapy within 8 weeks
- Recent checkpoint inhibitor treatment within 2 cycles
- Major surgery within 3 months
- Inadequate organ or bone marrow function including low hemoglobin, neutrophil, or platelet counts, elevated liver enzymes, bilirubin, or creatinine clearance below 30 mL/min
- History of pelvic radiation
- Difficult catheterization preventing safe drug administration
- Interstitial cystitis or inability to hold about 2 ounces of bladder fluid for treatment retention
- Active uncontrolled infections requiring systemic therapy
- Known HIV, Hepatitis B or C infections
- Recent or symptomatic Covid-19 infection
- Significant cardiovascular risks
- Pregnant or breastfeeding women
- Participation in other investigational agent trials within 6 weeks
- Any other major or unstable medical condition affecting study participation or life expectancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
Research Team
D
Denise Juhr, BS
CONTACT
M
Mohamad Abou Chakra, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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