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

NCT02202772 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-02-24

No results posted yet for this study

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.

Conditions

  • Urothelial Carcinoma of the Urinary Bladder

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

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Guarionex J. Decastro

    lead OTHER

Principal Investigators

  • Guarionex DeCastro, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-01
Primary Completion
2026-04-30
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02202772 on ClinicalTrials.gov