CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 89 enrolled
Drug / intervention
Gemcitabine, +2 moredrug
Likely dose
Gemcitabine, 1000 mg/m2from 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/NCT00645593
NCT00645593Phase 2Completed
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Phase II Randomized Trial of Gemcitabine and Cisplatin With or Without Cetuximab in Patients With Urothelial Carcinoma

University of Michigan Rogel Cancer Center·interventional·Posted Mar 27, 2008·Updated May 23, 2016

In Brief

A Phase 2 clinical trial evaluating Gemcitabine,, Cisplatin, and 1 other intervention for Bladder Cancer. Completed, enrolled 89 participants across 14 sites.

Detailed Summary

This study will compare the effects, good and/or bad, of chemotherapy (Gemcitabine and Cisplatin) with or without the addition of the chemotherapy drug Cetuximab to find out which treatment is better.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesUnited States
CollaboratorsNational Comprehensive Cancer Network, Bristol-Myers Squibb, Eli Lilly and Company

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 27, 2008
Enrollment StartMar 1, 2008
Primary CompletionApr 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 18.3 years ago

Interventions

Gemcitabine,drug

Gemcitabine will be administered intravenously at a dose of 1000 mg/m2 on Days 1, 8 and 15 of cycle. One treatment cycle is 28 days.

Cisplatindrug

Cisplatin will be administered intravenously at a dose of 70 mg/m2 per institutional standards on Day 1 of each cycle.

Cetuximabdrug

Cetuximab will be administered intravenously at a dose of 500 mg/m2 on Days 1 and 15 of each cycle. One treatment cycle is 28 days.