CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 27 enrolled
Drug / intervention
Gemcitabine +1 moredrug
Likely dose
Gemcitabine 1gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04386746
NCT04386746Phase 2Active
CompareCT.gov

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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted May 13, 2020·Updated Nov 17, 2025

In Brief

A Phase 2 clinical trial evaluating Gemcitabine and Docetaxel for Urothelial Carcinoma Bladder and Bladder Cancer. Active but no longer recruiting, targeting 27 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrothelial Carcinoma Bladder, Bladder Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2Active
2021202220232024202520262027
First PostedMay 13, 2020
Enrollment StartJul 29, 2020
Primary CompletionOct 4, 2022
Study CompletionNov 30, 2026
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 6.1 years ago

Interventions

Gemcitabinedrug

1g gemcitabine in 50ml sterile water; instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.

Docetaxeldrug

37.5mg docetaxel in 50ml normal saline solution (NSS); instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.