Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445406
Status:
COMPLETED
Last Update Posted:
2012-06-28
First Post:
2007-03-07
Brief Title:
Bevacizumab and Doxorubicin Hydrochloride Liposome in Treating Women With Locally Recurrent or Metastatic Breast Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Bevacizumab and Pegylated Liposomal Doxorubicin as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer A Multicenter Single-Arm Phase II Trial
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
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 Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab also may stop the growth of breast cancer by blocking blood flow to the tumor Drugs used in chemotherapy such as doxorubicin hydrochloride liposome work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving bevacizumab together with doxorubicin hydrochloride liposome may kill more tumor cells
PURPOSE This phase II trial is studying the side effects and how well giving bevacizumab together with doxorubicin hydrochloride liposome works in treating women with locally recurrent or metastatic breast cancer
PURPOSE This phase II trial is studying the side effects and how well giving bevacizumab together with doxorubicin hydrochloride liposome works in treating women with locally recurrent or metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety and tolerability of bevacizumab and doxorubicin hydrochloride liposome in women with locally recurrent or metastatic breast cancer
Secondary
Determine the efficacy of this regimen in these patients
Identify surrogate markers of angiogenesis including vascular endothelial growth factor VEGF VEGF receptor 1 and matrix metalloproteinase 9 in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive bevacizumab IV over 30-90 minutes and doxorubicin hydrochloride liposome IV over 30-90 minutes on days 1 and 15 Treatment repeats every 4 weeks for up to 6 courses Patients then receive bevacizumab alone IV over 30-90 minutes on days 1 and 15 Courses with bevacizumab repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
NOTE Patients may receive additional courses of doxorubicin hydrochloride liposome at the discretion of the primary investigator
Blood samples are collected at baseline on day 1 of course 3 and then once every 3 months during study treatment and after completion of study treatment Samples are analyzed by enzyme-linked immunosorbent assay to determine the level of circulating angiogenesis-related molecules including serum vascular endothelial growth factor VEGF VEGF receptor 1 and matrix metalloproteinase 9
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 43 patients will be accrued for this study
Primary
Determine the safety and tolerability of bevacizumab and doxorubicin hydrochloride liposome in women with locally recurrent or metastatic breast cancer
Secondary
Determine the efficacy of this regimen in these patients
Identify surrogate markers of angiogenesis including vascular endothelial growth factor VEGF VEGF receptor 1 and matrix metalloproteinase 9 in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive bevacizumab IV over 30-90 minutes and doxorubicin hydrochloride liposome IV over 30-90 minutes on days 1 and 15 Treatment repeats every 4 weeks for up to 6 courses Patients then receive bevacizumab alone IV over 30-90 minutes on days 1 and 15 Courses with bevacizumab repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
NOTE Patients may receive additional courses of doxorubicin hydrochloride liposome at the discretion of the primary investigator
Blood samples are collected at baseline on day 1 of course 3 and then once every 3 months during study treatment and after completion of study treatment Samples are analyzed by enzyme-linked immunosorbent assay to determine the level of circulating angiogenesis-related molecules including serum vascular endothelial growth factor VEGF VEGF receptor 1 and matrix metalloproteinase 9
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 43 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20701 | None | None | None |