Study of Genexol-PM in Patients With Advanced Urothelial Cancer Previously Treated With Gemcitabine and Platinum

PHASE2CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

July 31, 2010

Study Completion Date

August 31, 2011

Conditions
Bladder CancerUreter Cancer
Interventions
DRUG

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)

Trial Locations (1)

138-736

Asan Medical Center, Seoul

Sponsors
All Listed Sponsors
collaborator

Samsung Medical Center

OTHER

collaborator

Kangdong Sacred Heart Hospital

OTHER

lead

Asan Medical Center

OTHER

NCT01426126 - Study of Genexol-PM in Patients With Advanced Urothelial Cancer Previously Treated With Gemcitabine and Platinum | Biotech Hunter | Biotech Hunter