Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC

Recruiting Phase 2 Interventional Study
Bladder Cancer Non-Muscle Invasive Bladder Cancer (NMIBC) Urothelial Carcinoma Carcinoma in Situ (CIS) High-Grade Papillary Bladder Tumors BCG-Unresponsive Bladder Cancer Ta Stage Bladder Cancer T1 Stage Bladder Cancer BCG-Refractory Bladder Cancer High-Risk NMIBC Micropapillary Variant Urothelial Carcinoma (Favorable Subtype)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
174 (estimated)
Sponsor
Michael A. O'Donnell · Other
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About This Trial
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. T…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of urothelial carcinoma of the bladder without synchronous or metachronous upper tract involvement or prostatic urethral involvement. Subjects with negative upper tract imaging within 6 months of the study start and visually normal prostates ar…
Contacts

Denise Juhr, BS

(319) 467-6313

denise-juhr@uiowa.edu

CONTACT

Mohamad Abou Chakra, MD

319-467-7053

mohamad-abouchakra@uiowa.edu

CONTACT