Docetaxel, Capecitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel and capecitabine together with bevacizumab works in treating patients with metastatic breast cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Of Docetaxel With Capecitabine And Bevacizumab As First-Line Chemotherapy For Patients With Metastatic Breast Cancer|
- Confirmed tumor response (complete or partial) rate as measured by RECIST [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Adverse event profile [ Designated as safety issue: Yes ]
|Study Start Date:||December 2004|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- Determine the response rate in patients with metastatic breast cancer treated with docetaxel, capecitabine, and bevacizumab as first-line chemotherapy.
- Determine time to disease progression in patients treated with this regimen.
- Determine survival of patients treated with this regimen.
- Determine the toxicity profile of this regimen in these patients.
- Determine the duration of response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study within 8 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088998
|Study Chair:||Edith A. Perez, MD||Mayo Clinic|
|Investigator:||Todor Dentchev, MD||Altru Cancer Center at Altru Hospital|