Phase II Trial of Abraxane Administered on a Weekly Schedule in Combination With Bevacizumab in Metastatic Breast Cancer
OBJECTIVES:
Primary
- Determine the activity of paclitaxel albumin-stabilized nanoparticle formulation
(ABI-007; Abraxane^®) and bevacizumab, in terms of progression-free survival and
response rate, in women with recurrent or metastatic breast cancer.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the feasibility of this regimen in these patients.
OUTLINE: This is an open-label, pilot study.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007;
Abraxane^®) IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on
days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Progression-free survival as measured by RECIST criteria at 1 and 2 years
No
Linnea Chap, MD
Principal Investigator
Premiere Oncology
United States: Federal Government
CDR0000515534
NCT00404404
October 2006
Name | Location |
---|---|
Premiere Oncology | Santa Monica, California 90404 |