Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and methotrexate, work in different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of breast cancer by stopping blood flow to the tumor. Giving metronomic (regularly timed) low-dose cyclophosphamide and methotrexate together with bevacizumab may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying metronomic low-dose cyclophosphamide and methotrexate to see how well they work compared to metronomic low-dose cyclophosphamide, methotrexate, and bevacizumab in treating women with metastatic breast cancer.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Metronomic Chemotherapy in Combination With Bevacizumab for Advanced Breast Cancer|
- Clinical response rate (complete and partial) as measured by RECIST criteria [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
|Study Start Date:||November 2002|
- Compare the overall response rate in women with metastatic breast cancer treated with metronomic low-dose cyclophosphamide and methotrexate with or without bevacizumab.
- Compare the progression-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Correlate markers of angiogenesis, including vascular endothelial growth factor and circulating endothelial cells, at baseline and during treatment, with response in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive low-dose oral cyclophosphamide once daily on days 1-28, low-dose oral methotrexate twice daily on days 1, 2, 8, 9, 15, 16, 22 and 23, and bevacizumab IV over 30-90 minutes on days 1 and 15.
- Arm II: Patients receive cyclophosphamide and methotrexate as in arm I. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients in arm II who have progressive disease have the option of discontinuing treatment or crossing over to arm I.
PROJECTED ACCRUAL: A total of 36-66 patients (18-33 per treatment arm) will be accrued for this study within 7-12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00083031
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Harold J. Burstein, MD, PhD||Dana-Farber Cancer Institute|