drugset / Trial / NCT05644041

Intravesical Gem/Doce in Patients With NMIBC

NCT05644041 ↗

Phase 2 Active not recruiting 31 enrolled University of Arizona
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-03-01
Primary completion
2027-01-31
Completion
2027-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 40 mg Other
Subject Gemcitabine Small molecule 1000 mg Other