Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Michael A. O'Donnell
Study ID
NCT07322263
Phase
PHASE2
Status
Recruiting
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Conditions

  • BCG-Refractory Bladder Cancer
  • BCG-Unresponsive Bladder Cancer
  • Bladder Cancer
  • Carcinoma in Situ (CIS)
  • High-Grade Papillary Bladder Tumors
  • High-Risk NMIBC
  • Micropapillary Variant Urothelial Carcinoma (Favorable Subtype)
  • Non-Muscle Invasive Bladder Cancer (NMIBC)
  • T1 Stage Bladder Cancer
  • Ta Stage Bladder Cancer
  • Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Intravesical Gemcitabine and Docetaxel — DRUG
    Sequential intravesical administration of Gemcitabine (1000mg) followed by Docetaxel (37 mg), delivered via sterile urethral catheter. Each drug is retained in the bladder for 60 minutes per instillation. The treatment consists of a 6-week induction phase (weekly instillations), followed by a 24-month maintenance phase (monthly instillations). This regimen is designed for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), including carcinoma in situ (CIS) and high-grade papillary tumors (Ta/T1). The study evaluates efficacy, tolerability, and bladder preservation outcomes.

Study Details

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

Key Dates

Start date
Apr 10, 2026
Status verified
Apr 2026
Primary completion
Jan 1, 2033
Completion
Jan 1, 2033

Study Design

Enrollment
174 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    High-grade non-muscle-invasive bladder cancer (HG NMIBC) with carcinoma in situ (CIS), either as pure CIS or concurrent with papillary tumors.
  • Experimental: Arm B
    High-grade non-muscle-invasive bladder cancer (HG NMIBC) with high-grade papillary tumors (stages Ta and/or T1) without carcinoma in situ (CIS).

Primary Outcome Measure

Efficacy of Intravesical Gemcitabine/Docetaxel in BCG-Unresponsive Carcinoma In Situ NMIBC [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Denise Juhr, BS
[email protected]
(319) 467-6313
Mohamad A Abou Chakra, MD
[email protected]
Michael A O'Donnell, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Iowa City, IA

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
University of Iowa· Iowa City, IA

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