54
Participants
Start Date
June 30, 2009
Primary Completion Date
July 31, 2013
Study Completion Date
September 30, 2014
Paclitaxel
IV infusion per institutional guidelines on Days 1, 8 and 15 of a 28 day cycle as follows depending on dose level (DL): DL1- 70 mg/m2, DL2- 80 mg/m2, DL3- 80mg/m2, DL4- 80mg/m2, DL-1- 70mg/m2, DL-2- 60mg/m2
Carboplatin
IV infusion per institutional guidelines Day 1 of a 28 day cycle as follows depending on dose level (DL): DL1- AUC=5, DL2- AUC=5, DL3- AUC=6, DL4- AUC=6, DL-1- AUC=4, DL-2- AUC=4
Sunitinib
By mouth (PO) once daily on days 1-21 of a 28 day cycle as follows depending on dose level (DL): DL1- 25mg, DL2-25mg, DL3- 25mg, DL4- 37.5mg, DL-1- 25mg, DL-2- 25mg. Maintenance therapy of 25mg daily
Center for Cancer and Blood Disorders, Bethesda
National Capital Clinical Research Consortium, Bethesda
Northeast Georgia Medical Center, Gainesville
Holy Cross Hospital, Fort Lauderdale
Florida Cancer Specialists North, Fort Myers
Florida Cancer Specialists South, Fort Myers
Tennessee Oncology, PLLC, Nashville
Family Cancer Center, Collierville
Baptist Hospital East, Louisville
Providence Medical Group, Terre Haute
St. Louis Cancer Care, Chesterfield
Nebraska Methodist Cancer Center, Omaha
Cancer Centers of Southwest Oklahoma, Lawton
Hematology Oncology Associates of Northern NJ, Morristown
Collaborators (1)
Pfizer
INDUSTRY
SCRI Development Innovations, LLC
OTHER