Study on Using Gemcitabine for Treating Non-Muscle Invasive Bladder Cancer (NMIBC)

Sponsor: University of Arizona

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05644041

Provider View

This clinical trial is exploring the use of Gemcitabine, a chemotherapy drug, for patients with non-muscle invasive bladder cancer who cannot use or did not respond to the standard BCG treatment. The study aims to understand how effective Gemcitabine is in preventing cancer recurrence.

Patient Parameters

Program Overview

This study focuses on using Gemcitabine, a chemotherapy drug, directly in the bladder to treat non-muscle invasive bladder cancer (NMIBC). Typically, a treatment called BCG is used first, but not all patients respond well to it, and there are limited options if it fails. Due to shortages of BCG, Gemcitabine is being used as an alternative. The study aims to learn more about how well Gemcitabine works for patients who cannot use BCG or for whom BCG has not been effective.

Eligibility Criteria

Inclusion Criteria

  • Able to understand and consent to the study in English or Spanish.
  • Willing to follow all study procedures and available for the study duration.
  • Male or female, 18 years or older.
  • Have intermediate or high-risk non-muscle invasive bladder cancer and have not had BCG treatment before.
  • Cancer confirmed by a specific type of bladder surgery within 180 days before joining the study, or have had a high-grade recurrence after 24 months since the last BCG treatment.
  • In good general health with an ECOG performance status of 0 to 2.
  • Have had bladder tumor removal surgery.
  • Women must be post-menopausal or have a negative pregnancy test if pre-menopausal.

Exclusion Criteria

  • Allergic reaction to Gemcitabine.
  • Cancer that has spread to the muscle or beyond in the bladder.
  • Cancer with certain specific cell types or characteristics.
  • Other active cancers besides the bladder cancer being studied.
  • Cancer in the upper urinary tract (like the ureter or kidney area).
  • Pregnant or breastfeeding women.
  • Substance abuse or psychiatric issues that would prevent following the study protocol.

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