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Intravesical Gem/Doce in Patients With NMIBC

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment increased: 25 → 31 participants
    • Site details revised
    v12
  2. Primary and study completion dates: Jan 31, 2026 to Jan 31, 2027v11
  3. Trial status: Suspended to Recruitingv10 Show 4 more changesShow less
    • Interventions: Gemcitabine (Drug) to gemcitabine + docetaxel (Drug)
    • Site details revised
    • Study title revised
    • Eligibility criteria expanded, about 2 words
  4. Trial status: Recruiting to Suspended Sponsor's reason: The protocol is currently being amended. The study will re-open once the amendment receives IRB approval.
    • Site details revised
    v9
  5. Primary and study completion dates: Jan 31, 2025 to Jan 31, 2026v8
Show 6 earlier versionsHide 6 earlier versions
  1. Re-verified, no change to tracked fieldsv7
  2. Site contact updatedv6
  3. Eligibility criteria revisedv5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
  5. Start date: Feb 1, 2023 to Mar 1, 2023
    • Eligibility criteria expanded, about 11 words
    v3
  6. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05644041
Lead Sponsor University of Arizona
Conditions
(from sponsor)		 Urinary Bladder Cancer
Related terms Urinary Bladder Neoplasms
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov