Carboplatin, Paclitaxel, and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as carboplatin 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. 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 cancer-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving carboplatin and paclitaxel together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and paclitaxel together with bevacizumab works in treating patients with locally recurrent or metastatic breast cancer.
Drug: ABI-007l albumin-stabilized nanoparticle formulation
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Carboplatin, Nanoparticle Albumin-Bound Paclitaxel (ABI-007) and Avastin as the First Line Therapy in Metastatic Breast Cancer.|
- Progression-free survival [ Time Frame: Ongoing ] [ Designated as safety issue: No ]Treatment will continue until disease progression.
- Response rate [ Time Frame: every 63 days ] [ Designated as safety issue: No ]The cycle length is 63 days. Treatment will continue until disease progression
- Overall survival [ Time Frame: Ongoing ] [ Designated as safety issue: No ]Patients will be followed for a maximum of 2 years after progression or until death
- Toxicity profile [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||September 2015|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
|Experimental: Carboplatin, ABI-007 and Bevacizumab||
Bevacizumab 15mg/kg on Days 1,22, 43.Drug: carboplatin
Carboplatin AUC 6 Day 1, 22, 43.Drug: ABI-007l albumin-stabilized nanoparticle formulation
ABI-007 100mg/m2 Days 1,8, 15, 22, 29, 36,43,50.
- To determine the progression-free survival of patients with locally recurrent or metastatic breast cancer treated with carboplatin, paclitaxel albumin-stabilized nanoparticle formulation, and bevacizumab as first-line therapy.
- To determine the response rate in these patients.
- To determine the overall survival of these patients.
- To evaluate the toxicity profile of this regimen in these patients.
OUTLINE: Patients receive carboplatin IV over 1 hour and bevacizumab IV on days 1, 22 and 43. Patients also receive paclitaxel albumin-bound nanoparticle formulation IV over 30 minutes on days 1, 8 ,15, 22, 29, 36, 43, and 50. Treatment continues in the absence of disease progression or unacceptable toxicity.
Formalin-fixed paraffin-embedded archived tumor tissue samples are assessed by IHC for various biomarkers. Levels of Notch-1, Notch-4, cyclin A, cyclin B, Jagged-1, and DLL4 in tumor-associated endothelial cells are correlated with response in both estrogen- and progesterone-positive and negative tumors, and independently of p53 status.
After completion of study treatment, patients are followed for up to 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654836
|United States, Illinois|
|Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital|
|Downers Grove, Illinois, United States, 60515-1500|
|Delnor Community Hospital - Geneva|
|Geneva, Illinois, United States, 60134-4200|
|Cardinal Bernardin Cancer Center at Loyola University Medical Center|
|Maywood, Illinois, United States, 60153|
|Edward Hospital Cancer Center|
|Naperville, Illinois, United States, 60540|
|Swedish-American Regional Cancer Center|
|Rockford, Illinois, United States, 61104-2315|
|Central Dupage Cancer Center|
|Winfield, Illinois, United States, 60190-1295|
|Principal Investigator:||Shelly Lo, MD||Loyola University|