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Brief Title: Gemzar, Cisp, Sunitinib Urothelial Ca
Official Title: Phase II Trial of Gemcitabine, Cisplatin, and Sunitinib in Patients With Advanced/Metastatic Urothelial Carcinoma
Study ID: NCT00821327
Brief Summary: The primary objective of this nonrandomized Phase II study is to evaluate the objective response rate (ORR, CR+PR) in patients with advanced/metastatic UC treated with the combination of gemcitabine, cisplatin, and sunitinib.
Detailed Description: Given the strong preclinical rationale for targeting angiogenesis in urothelial carcinoma (UC), the evidence supporting co-targeting of VEGFR2 and PDGF, the safety and efficacy of single-agent sunitinib in patients with UC, and preclinical evidence of synergy with the combination of sunitinib and cisplatin, the evaluation of sunitinib in combination with gemcitabine plus cisplatin in previously untreated patients with metastatic UC is warranted.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Arizona Oncology Associates, Tucson, Arizona, United States
Advanced Medical Specialties, Miami, Florida, United States
Florida Cancer Institute - New Hope, New Port Richey, Florida, United States
Cancer Centers of Florida, P.A., Ocoee, Florida, United States
Hematology Oncology Associates of Illinois, Chicago, Illinois, United States
Cancer Care & Hematology Specialists of Chicagoland, Niles, Illinois, United States
Central Indiana Cancer Centers, Indianapolis, Indiana, United States
Alliance Hematology Oncology PA., Westminster, Maryland, United States
Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota, United States
Missouri Cancer Associates, Columbia, Missouri, United States
Arch Medical Services, Inc., St. Louiis, Missouri, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Hematology-Oncology Associates of Northern NJ, PA, Morristown, New Jersey, United States
New Mexico Cancer Care Associates, Santa Fe, New Mexico, United States
New York Oncology Hematology, P.C., Albany, New York, United States
Raleigh Hematology Oncology Associates, Raleigh, North Carolina, United States
Willamette Valley Cancer Center, Springfield, Oregon, United States
Medical Oncology Associates of Wyoming Valley, PC, Kingston, Pennsylvania, United States
Cancer Centers of the Carolinas, Greenville, South Carolina, United States
Texas Cancer Center - Abilene, Abilene, Texas, United States
Texas Oncology, P.A. -Amarillo, Amarillo, Texas, United States
Texas Cancer Center, Arlington, Texas, United States
Texas Oncology - Round Rock Cancer Center, Austin, Texas, United States
Mamie McFaddin Ward Cancer Center, Texas Oncology, Beaumont, Texas, United States
Texas Oncology, P.A. - Bedford, Bedford, Texas, United States
Texas Oncology, Dallas, Texas, United States
Texas Oncology/Methodist Charlton Cancer Ctr., Dallas, Texas, United States
Texas Oncology, P.A., Dallas, Texas, United States
Texas Cancer Center, Denton, Texas, United States
El Paso Cancer Treatment Center - East, El Paso, Texas, United States
Texas Oncology, Fort Worth, Texas, United States
Texas Oncology, Garland, Texas, United States
Longview Cancer Center, Longview, Texas, United States
South Texas Cancer Center, McAllen, Texas, United States
Texas Oncology, PA, Allison Cancer Center, Midland, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Cancer Care Centers of South Texas-HOAST, San Antonio, Texas, United States
Texas Cancer Center - Sherman, Sherman, Texas, United States
Texas Oncology Cancer Center - Sugar Land, Sugar Land, Texas, United States
Tyler Cancer Center, Tyler, Texas, United States
Texas Oncology Cancer Care and Research Center, Waco, Texas, United States
Deke Slayton Cancer Center, Webster, Texas, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., Salem, Virginia, United States
Highline Medical Oncology, Burien, Washington, United States
Pudget Sound Cancer Center, Edmonds, Washington, United States
Cancer Care Northwest, Spokane, Washington, United States
Northwest Cancer Specialists, PC, Vancouver, Washington, United States
Name: Guru Sonpavde, MD
Affiliation: US Oncology
Role: PRINCIPAL_INVESTIGATOR
Name: Thomas E Hutson, DO
Affiliation: US Oncology
Role: PRINCIPAL_INVESTIGATOR