A Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab for Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Metastatic Breast Cancer
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (25)

10021

Weill Medical College Of Cornell University, New York

12100

Local Institution, Cuneo

13273

Local Institution, Marseille

20132

Local Institution, Milan

23007

Local Institution, Jaén

25030

Local Institution, Besançon

37044

Local Institution, Tours

41100

Local Institution, Modena

44805

Local Institution, Saint-Herblain

47014

Local Institution, Meldola Fc

52242

University Of Iowa Hospitals And Clinics, Iowa City

63000

Local Institution, Clermont-Ferrand

65203

Ellis Fischel Cancer Center, Columbia

67085

Local Institution, Strasbourg

75475

Local Institution, Paris

80131

Local Institution, Napoli

91505

East Valley Hematology And Oncology Medical Group, Burbank

91750

Wilshire Oncology Medical Group, Inc., La Verne

94115

Ucsf-Comprehensive Cancer Center, San Francisco

00161

Local Institution, Roma

08907

Local Institution, L'Hospitalet de Llobregat

CM1 7ET

Local Institution, Chelmsford

M20 4BX

Local Institution, Manchester

CH63 4JY

Local Institution, Merseyside

NG5 1PB

Local Institution, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

R-Pharm

INDUSTRY