Intravesical Gem/Doce in Patients With NMIBC

Launched by UNIVERSITY OF ARIZONA · Dec 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called intravesical Gemcitabine for patients with non-muscle invasive bladder cancer, which is a type of bladder cancer that hasn't spread deeply into the bladder wall. Gemcitabine is a chemotherapy drug that is being explored as an alternative for patients who either cannot receive Bacillus Calmette-Guérin (BCG) therapy or have not responded well to it. The goal of this study is to better understand how effective Gemcitabine can be for preventing or delaying the return of tumors in patients who are at intermediate or high risk.

To participate in this trial, patients need to be at least 18 years old and should have been diagnosed with non-muscle invasive bladder cancer that has been confirmed by a doctor. Participants will need to provide consent and be available for the study procedures. It's important to note that individuals who are pregnant, breastfeeding, or have certain other health conditions may not be eligible. Those who join the study can expect to receive Gemcitabine treatment and will be monitored by medical professionals to assess how well the treatment works and to ensure their safety throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients able to consent in English or Spanish; provision of signed and dated informed consent form
• • 2. Stated willingness to comply with all study procedures and availability for the duration of the study
• • 3. Male or female ages ≥18 years.
• • 4. Patients with intermediate or high-risk non-muscle-invasive UC of the bladder and no previous BCG treatment.
• • 1. Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on Transurethral Resection of Bladder Tumor (TURBT) must be obtained within 180 days of registration. OR Patients with a high-grade recurrence after 24 months since last dose of BCG.
• • 6. Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-2. 7. Post-transurethral bladder tumor resection. 8. Evidence of post-menopausal status or negative urinary pregnancy test of female pre-menopausal patients is required. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
• Exclusion Criteria:
• • 1. Known hypersensitivity reaction to gemcitabine and/or docetaxel.
• • 2. Clinical T2 or higher stage UC of the bladder.
• • 3. Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure CIS of the bladder.
• • 4. Active malignancies other than the disease being treated under study.
• • 5. Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage.
• • 6. Pregnant or breast-feeding women.
• • 7. Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol.