Phase II Randomized Trial of Gemcitabine and Cisplatin With or Without Cetuximab in Patients With Urothelial Carcinoma
Urothelial cancer typically begins in the lining of the bladder, the balloon-shaped organ in
the pelvic area that stores urine. Urothelial cancer can also begin in the ureter (the tube
connecting the kidney and bladder), part of the kidney itself, or the urethra (the tube you
pass urine out of). Some Urothelial cancers remain confined to the lining, while in other
cases they spread to other areas. Treatment for these cancers varies greatly depending on
the stage of disease at the time of diagnosis. Study participants in this research study
will have a diagnosis of urothelial cancer that is advanced or has come back after prior
There are two standard chemotherapeutic regimens for the management of this disease. One is
the combination of the drugs, methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC).
However the toxicities associated with this treatment regimen (side effects) is high.
The other is a combination of two drugs called Cisplatin and Gemcitabine. These drugs are
also known to destroy urothelial cancer cells, and are better tolerated by patients. All
study participants will receive both of these drugs.
Another anti-cancer drug called Cetuximab is known to delay or prevent tumor growth and in
some cases to lead to death of cancer cells by blocking certain cellular pathways that lead
to tumor development. This drug has been approved by the United States Food and Drug
Administration (FDA) for the treatment of colorectal cancer and for treatment of head and
neck cancers. The use of Cetuximab for the treatment of urothelial cancer is investigational
in this study.
The purpose of this study is to compare the safety and efficacy of Gemcitabine and Cisplatin
administered with or without the addition of Cetuximab in study participants with urothelial
This is a randomized research study. Study participants will be randomized to receive either
gemcitabine and cisplatin alone or in combination with Cetuximab.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare the overall response rate of combination gemcitabine and cisplatin with or without cetuximab in patients with locally advanced or metastatic urothelial carcinoma
Maha Hussain, M.D.
University of Michigan
United States: Institutional Review Board
|University of Michigan||Ann Arbor, Michigan 48109-0624|
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Stanford University||Stanford, California 94305|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Boston Medical Center||Boston, Massachusetts 02118|
|University of Washington||Seattle, Washington 98195|
|Lahey Clinic||Burlington, Massachusetts 01805|
|University of Texas MD Anderson Cancer Center||Houston, Texas 77030|
|University of Utah Huntsman Cancer Institute||Salt Lake City, Utah 84112|
|City of Hope Cancer Center||Duarte, California 91010|
|Kenneth J. Norris Jr. Comprehensive Cancer Center, Keck School of Medicine, University of Southern California||Los Angeles, California 90033|
|Robert H. Lurie Comprehensive Cancer Center, Center of Northwestern University||Chicago, Illinois 60611|
|Wayne State University/Karmanos Cancer Institute||Detroit, Michigan 48201|