NCT04386746

Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer

A Phase II Trial for the Use of Intravesical Gemcitabine and Docetaxel (GEMDOCE) in the Treatment of BCG naïve Non-muscle Invasive Urothelial Carcinoma of the Bladder

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A single-arm, two-stage, open-label, phase 2 study investigating the safety and efficacy of intravesical gemcitabine/docetaxel for bacillus Calmette-Guerin (BCG)-naïve patients with non-muscle invasive bladder cancer (NMIBC).

Detailed description

All participants will receive an induction course of gemcitabine/docetaxel instillations (administered once a week for six consecutive weeks) followed by monthly maintenance instillations if initial efficacy is seen. In addition to providing initial efficacy data, this study will provide safety and long-term efficacy data on the combination regimen studied. A tolerable safety profile and demonstrated efficacy would support a potential, randomized phase 3 trial comparing the experimental combination therapy and standard of care intravesical BCG therapy.

Conditions

• Urothelial Carcinoma Bladder
• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	1g gemcitabine in 50ml sterile water; instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.
DRUG	Docetaxel	37.5mg docetaxel in 50ml normal saline solution (NSS); instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.

Timeline

• Start date: 2020-07-29
• Primary completion: 2022-10-04
• Completion: 2026-11-30
• First posted: 2020-05-13
• Last updated: 2025-11-17
• Results posted: 2023-09-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study