Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436709
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2007-02-15
Brief Title:
Bevacizumab Doxorubicin and Cyclophosphamide Followed By Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab in Treating Patients Who Have Undergone Surgery for Early-Stage Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study of Bevacizumab With Dose Dense Doxorubicin and Cyclophosphamide AC Followed by Dose Dense Nanoparticle Albumin Bound Paclitaxel for the Treatment of Early Stage Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2007-06
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 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 may also stop the growth of breast cancer by blocking blood flow to the tumor Drugs used in chemotherapy such as doxorubicin cyclophosphamide and paclitaxel albumin-stabilized nanoparticle formulation 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 chemotherapy after surgery may kill any tumor cells that remain after surgery
PURPOSE This clinical trial is studying the side effects and how well giving bevacizumab together with doxorubicin and cyclophosphamide followed by paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab works in treating patients who have undergone surgery for early-stage breast cancer
PURPOSE This clinical trial is studying the side effects and how well giving bevacizumab together with doxorubicin and cyclophosphamide followed by paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab works in treating patients who have undergone surgery for early-stage breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the cardiac safety of adjuvant concurrent bevacizumab and dose-dense doxorubicin hydrochloride and cyclophosphamide followed by dose-dense paclitaxel albumin-stabilized nanoparticle formulation and maintenance therapy comprising bevacizumab alone in patients with early-stage breast cancer
Secondary
Determine the noncardiac toxicity of this regimen in these patients
Determine the efficacy of this regimen in terms of time to tumor recurrence and overall survival in these patients
Explore changes in circulating endothelial cells and circulating tumor cells from pre-treatment levels in patients with no evidence of disease
Prospectively explore the use of serial troponin I as a predictor of cardiac toxicity in patients treated with this regimen
Prospectively explore the relationship between plasma renin activity and hypertension in patients treated with bevacizumab and chemotherapy
OUTLINE This is a nonrandomized pilot multicenter study
Patients receive doxorubicin hydrochloride IV cyclophophamide IV and bevacizumab IV over 30-90 minutes on day 1 and pegfilgrastim subcutaneously SC on day 2 Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and pegfilgrastim SC on day 2 Treatment with paclitaxel albumin-stabilized nanoparticle formulation and pegfilgrastim repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients then receive maintenance therapy comprising bevacizumab IV over 30-90 minutes on day 1 Treatment with maintenance therapy repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline and periodically during study treatment Samples are analyzed for circulating endothelial cells by flow cytomery FC circulating epithelial cells by immunocytochemistry and FC troponin I concentrations by enzyme immunoassay or chemiluminescent microparticle immunoassay and plasma renin activity by radioimmunoassay
After completion of study treatment patients are followed every 4-6 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study
Primary
Determine the cardiac safety of adjuvant concurrent bevacizumab and dose-dense doxorubicin hydrochloride and cyclophosphamide followed by dose-dense paclitaxel albumin-stabilized nanoparticle formulation and maintenance therapy comprising bevacizumab alone in patients with early-stage breast cancer
Secondary
Determine the noncardiac toxicity of this regimen in these patients
Determine the efficacy of this regimen in terms of time to tumor recurrence and overall survival in these patients
Explore changes in circulating endothelial cells and circulating tumor cells from pre-treatment levels in patients with no evidence of disease
Prospectively explore the use of serial troponin I as a predictor of cardiac toxicity in patients treated with this regimen
Prospectively explore the relationship between plasma renin activity and hypertension in patients treated with bevacizumab and chemotherapy
OUTLINE This is a nonrandomized pilot multicenter study
Patients receive doxorubicin hydrochloride IV cyclophophamide IV and bevacizumab IV over 30-90 minutes on day 1 and pegfilgrastim subcutaneously SC on day 2 Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and pegfilgrastim SC on day 2 Treatment with paclitaxel albumin-stabilized nanoparticle formulation and pegfilgrastim repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients then receive maintenance therapy comprising bevacizumab IV over 30-90 minutes on day 1 Treatment with maintenance therapy repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline and periodically during study treatment Samples are analyzed for circulating endothelial cells by flow cytomery FC circulating epithelial cells by immunocytochemistry and FC troponin I concentrations by enzyme immunoassay or chemiluminescent microparticle immunoassay and plasma renin activity by radioimmunoassay
After completion of study treatment patients are followed every 4-6 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 75 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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-06019 | None | None | None |