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Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC

NCT07322263 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2026-04-17

No results posted yet for this study

Summary

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

  • 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)

Interventions

DRUG

Intravesical Gemcitabine and Docetaxel

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.

Sponsors & Collaborators

  • Michael A. O'Donnell

    lead OTHER

Principal Investigators

  • Michael A O'Donnell, MD · University of Iowa

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-10
Primary Completion
2033-01-01
Completion
2033-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07322263 on ClinicalTrials.gov