136
Participants
Start Date
March 31, 2007
Primary Completion Date
November 30, 2009
Study Completion Date
November 30, 2009
Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg
Ixabepilone,16 mg/m\^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg
Ixabepilone, 40 mg/m\^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity (After Cycle 4, dose reduction to 32 mg/m\^2 was to be implemented for all subsequent cycles.) Bevacizumab, 15 mg/kg, administered as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg
Paclitaxel, 90 mg/m\^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
Weill Medical College Of Cornell University, New York
Local Institution, Cuneo
Local Institution, Marseille
Local Institution, Milan
Local Institution, Jaén
Local Institution, Besançon
Local Institution, Tours
Local Institution, Modena
Local Institution, Saint-Herblain
Local Institution, Meldola Fc
University Of Iowa Hospitals And Clinics, Iowa City
Local Institution, Clermont-Ferrand
Ellis Fischel Cancer Center, Columbia
Local Institution, Strasbourg
Local Institution, Paris
Local Institution, Napoli
East Valley Hematology And Oncology Medical Group, Burbank
Wilshire Oncology Medical Group, Inc., La Verne
Ucsf-Comprehensive Cancer Center, San Francisco
Local Institution, Roma
Local Institution, L'Hospitalet de Llobregat
Local Institution, Chelmsford
Local Institution, Manchester
Local Institution, Merseyside
Local Institution, Nottingham
Lead Sponsor
R-Pharm
INDUSTRY