Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT00404404
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2006-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ABI-007 and Bevacizumab in Treating Women With Recurrent or Metastatic Breast Cancer
Sponsor:
Premiere Oncology
Organization:
Study Overview
Official Title:
Phase II Trial of Abraxane Administered on a Weekly Schedule in Combination With Bevacizumab in Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving ABI-007 together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II is studying how well giving ABI-007 together with bevacizumab works in treating women with recurrent or metastatic breast cancer.
PURPOSE: This phase II is studying how well giving ABI-007 together with bevacizumab works in treating women with recurrent or metastatic breast cancer.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: