drugset / Trial / NCT02202772
Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the Treatment Urothelial Carcinoma of the Bladder
RandomizedSingle-groupOpen-labelTreatment
Summary
The investigators intend to evaluate the safety and toxicity profile of intravesically administered multidrug regimen of Cabazitaxel, Cisplatin and Gemcitabine in treatment refractory Transitional Cell Carcinoma.The investigators propose to conduct a combined phase I trial to assess the safety, toxicity, and efficacy of a novel multidrug intravesical regimen consisting of Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the treatment of BCG resistant non-muscle invasive urothelial carcinoma of the bladder. This phase I trial will have a combined dose and cycle-escalation scheme with enrollment of up to 24 patients.
Timeline
- Start
- 2014-12-01
- Primary completion
- 2026-04
- Completion
- 2028-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabazitaxel | Other / unclassified | 2.5 mg | Other |
| Subject | Cabazitaxel | Other / unclassified | 5 mg | Other |
| Subject | Cisplatin | Other / unclassified | 66 mg | Other |
| Subject | Cisplatin | Other / unclassified | 80 mg | Other |
| Subject | Cisplatin | Other / unclassified | 100 mg | Other |
| Subject | Gemcitabine | Small molecule | 2000 mg | Other |