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ACTIVE NOT RECRUITING
NCT02202772
PHASE1/PHASE2

Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the Treatment Urothelial Carcinoma of the Bladder

Sponsor: Guarionex J. Decastro

View on ClinicalTrials.gov

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.

Official title: A Phase I/II Trial for the Use of Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the Treatment of BCG-Refractory Non-muscle Invasive Urothelial Carcinoma of the Bladder Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

51

Start Date

2014-12-01

Completion Date

2028-04

Last Updated

2025-02-24

Healthy Volunteers

No

Interventions

DRUG

Cabazitaxel

Intravesical instillation of the Cabazitaxel for 2 hours

DRUG

Gemcitabine

Intravesical instillation of Gemcitabine for 2 hours

DRUG

Cisplatin

Intravesical installation of Cisplatin for 2hours

Locations (1)

Columbia University Irving Medical Center - HIP

New York, New York, United States