drugset

drugset / Trial / NCT00645593

Study of Gemcitabine and Cisplatin With or Without Cetuximab in Urothelial Cancer

NCT00645593 ↗

Phase 2 Completed 89 enrolled University of Michigan Rogel Cancer Center Bristol-Myers Squibb · collab Eli Lilly and Company · collab National Comprehensive Cancer Network · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2008-03
Primary completion: 2014-04
Completion: 2015-06

Publications

Hussain M, Daignault S, Agarwal N, Grivas PD, Siefker-Radtke AO, Puzanov I, MacVicar GR, Levine EG, Srinivas S, Twardowski P, Eisenberger MA, Quinn DI, Vaishampayan UN, Yu EY, Dawsey S, Day KC, Day ML, Al-Hawary M, Smith DC. A randomized phase 2 trial of gemcitabine/cisplatin with or without cetuximab in patients with advanced urothelial carcinoma. Cancer. 2014 Sep 1;120(17):2684-93. doi: 10.1002/cncr.28767. Epub 2014 May 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cetuximab	Monoclonal antibody	500 mg/m2	Intravenous
Subject	Cisplatin	Other / unclassified	70 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

Indications