At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 13 enrolled
Drug / intervention
trastuzumab +2 moredrug
Likely dose
trastuzumab 4 mg/kgfrom 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.
An Open-label Pilot Study Evaluating the Effect of a Combination Regimen of Herceptin, Cisplatin, and Gemcitabine on Time to Disease Progression in Patients With Metastatic Urothelial Cancer
In Brief
A Phase 2 clinical trial evaluating trastuzumab, gemcitabine, and 1 other intervention for Urinary Tract Cancer. Completed, enrolled 13 participants across 7 sites.
Detailed Summary
This study will evaluate the efficacy and safety of a chemotherapy regimen of intravenous Herceptin, cisplatin and gemcitabine in patients with metastatic urothelial cancer. The anticipated time on study treatment is until disease progression.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Tract Cancer
CountriesGermany
Collaborators--
Timeline
Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2001
Primary CompletionJan 2010
First PostedDec 2013
TodayJul 2026
First PostedDec 10, 2013
Enrollment StartJan 1, 2001
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 12.6 years ago
Interventions
trastuzumabdrug
4 mg/kg i.v., Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v., Day 1 of Cycle 2 until disease progression
gemcitabinedrug
1200 mg/m2 i.v. on Days 1, 8, and 15 of Cycle 1 through 6
cisplatindrug
70 mg/m2 i.v. on Day 2 of Cycles 1 through 6