RecruitingPhase 2NCT05644041

Intravesical Gem/Doce in Patients With NMIBC

Phase II Trial of Intravesical Gemcitabine + Docetaxel in Patients With Nonmuscle Invasive Bladder Cancer With or Without Prior Bacillus Calmette-Guérin Therapy

Sponsor

University of Arizona

Enrollment

25 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Urinary Bladder Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two chemotherapy drugs — gemcitabine and docetaxel — delivered directly into the bladder (called intravesical therapy) for people with non-muscle-invasive bladder cancer who have not previously received BCG (a standard bladder cancer treatment). **You may be eligible if...** - You are 18 years or older - You have intermediate or high-risk bladder cancer that does not invade the muscle wall, confirmed by a biopsy (TURBT procedure) within the last 6 months, AND you have not had BCG treatment before. OR you have a high-grade cancer recurrence more than 24 months after your last BCG dose - Your general health is acceptable (ECOG 0–2) - You can provide consent in English or Spanish **You may NOT be eligible if...** - Your bladder cancer has invaded the muscle layer - You have received BCG recently (within the past 24 months without a high-grade recurrence) - You have serious kidney, liver, or blood problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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