At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 17 enrolled
Drug / intervention
Gemcitabine +2 moredrug
Likely dose
Gemcitabine 1000 mgfrom 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.
A Phase II, Multicenter Trial of Gemcitabine, Carboplatin, and Sorafenib in Chemotherapy-naive Patients With Advanced/Metastatic Bladder Carcinoma
In Brief
A Phase 2 clinical trial evaluating Gemcitabine, Carboplatin, and 1 other intervention for Bladder Cancer. Completed, enrolled 17 participants across 1 site.
Detailed Summary
This is a Phase II, nonrandomized multicenter study designed to evaluate time to progression and response proportion of patients with advanced or metastatic transitional cell carcinoma of bladder receiving 6 cycles of gemcitabine, carboplatin and sorafenib and then maintenance sorafenib.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesUnited States
CollaboratorsBayer
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedApr 2007
Primary CompletionAug 2013
TodayJul 2026
First PostedApr 18, 2007
Enrollment StartMar 1, 2007
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 19.2 years ago
Interventions
Gemcitabinedrug
Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.
Carboplatindrug
Carboplatin will be given on day 1 to an AUC of 5.
Sorafenibdrug
Sorafenib will be administered orally daily on days 2-19 at 400 mg bid