107
Participants
Start Date
May 31, 2001
Primary Completion Date
December 31, 2006
Study Completion Date
January 31, 2010
PS-341
PS-341 will be administered as an intravenous push into a side arm of either a peripheral or central intravenous line infusing normal saline at 100 ml/hr. Patients will be treated twice weekly for two weeks, followed by a one week rest period, such that the typical days of treatment will be days 1, 4, 8, 11 of each three-week cycle. The initial dose level for PS-341 will be 0.9 mg/m2/dose intravenously, while subsequent dose levels will be determined according to a modified Fibonacci schema
Doxil
Doxil will be administered at a dose of 30 mg/m2 as a 1 hour infusion through either a peripheral or central intravenous line every 3 weeks (on day 4 of each 21 day cycle)
Velcade
Velcade will be adminstered intravenously at 1.3 mg/m2 days 1, 4, 8, 11 every 3 weeks
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill
National Cancer Institute (NCI)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER