Study on Using Gemcitabine and Docetaxel for Treating Low Grade Intermediate Risk Bladder Cancer

Sponsor: University of Florida

Sponsor score: 60

ClinicalTrials ID:NCT06488222

This clinical trial is exploring a treatment for low grade intermediate risk bladder cancer using two drugs, gemcitabine and docetaxel, delivered directly into the bladder. The study aims to see if this approach can help reduce the chance of the cancer coming back.

Patient Parameters

Program Overview

Bladder cancer is a common type of cancer, and many cases are diagnosed at an early stage where the cancer hasn't spread beyond the bladder. This study is looking at a treatment for low grade intermediate risk bladder cancer, which is a type of early-stage cancer. The treatment involves using two drugs, gemcitabine and docetaxel, that are placed directly into the bladder to see if they can help prevent the cancer from returning. The study will also look at how well patients can stick to the treatment plan.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older.
  • Diagnosed with low-grade intermediate risk bladder cancer, which includes:
    • Recurrent low-grade Ta
    • A single low-grade Ta tumor larger than 3 cm
    • Multiple low-grade Ta tumors
  • In good general health with an ECOG performance status of 0 to 2.
  • No signs of cancer in the upper urinary tract based on imaging tests.
  • No cancer in the urethra based on a bladder examination.
  • No visible cancer in the bladder within 60 days before joining the study.
  • Neutrophil count of at least 1500 cells/mm³.
  • If you have another type of cancer, it must not interfere with this study's treatment or safety assessments.
  • Women who can become pregnant must use effective birth control during the study and for 6 months after the last treatment.
  • Men with partners who can become pregnant must use effective birth control during the study and for 3 months after the last treatment.
  • Must provide written consent to participate and follow study procedures.

Exclusion Criteria

  • History of high-grade bladder cancer or cancer in the upper urinary tract.
  • Previous treatment with BCG therapy in the bladder.
  • Diagnosed with pure squamous cell carcinoma or adenocarcinoma.
  • Any neuroendocrine carcinoma component.
  • Physical issues that prevent placing a catheter in the urethra.
  • Small bladder capacity that prevents treatment with the study drugs.
  • Women who can become pregnant and are not willing to use birth control during the study and for 6 months after.
  • Currently pregnant or breastfeeding.
  • Any other health condition that could make the treatment unsafe or affect study results, as judged by the doctor.
  • Received a live virus vaccine within 30 days before starting the study treatment.
  • Individuals who are incarcerated or detained for psychiatric or physical illness.

Locations

FACILITYZIPCITYSTATE
University of Florida32608GainesvilleFlorida

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