37
Participants
Start Date
December 31, 2007
Primary Completion Date
July 31, 2010
Study Completion Date
August 31, 2011
Genexol PM
Genexol-PM at a dose of 240 mg/㎡ was diluted in 500 ml of 5% dextrose solution and infused i.v. for 3 hours on day 1. Specialized i.v. infusion sets or in-line filter was not required for the administration. The dose of Genexol-PM was escalated to 300 mg/㎡ from the second cycle when pre-specified criteria were fulfilled (nadir ANC ≥ 1,000/ mm3, nadir platelet count ≥ 100,000/ mm3, and no grade 2 or worse non-hematologic toxicities with the exception of alopecia)
Asan Medical Center, Seoul
Lead Sponsor
Samsung Medical Center
OTHER
Kangdong Sacred Heart Hospital
OTHER
Asan Medical Center
OTHER