Vinflunine and Capecitabine in Treating Patients With Previously Treated Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as vinflunine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vinflunine together with capecitabine works in treating patients with previously treated metastatic breast cancer.
Procedure: quality-of-life assessment
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Vinfluinine and Capecitabine in Previously Treated Metastatic Breast Cancer|
- Confirmed tumor response [ Designated as safety issue: No ]
- Adverse event profile [ Designated as safety issue: Yes ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
- Evaluate the tumor response rate in patients with previously treated metastatic breast cancer treated with vinflunine and capecitabine.
- Describe the adverse event profile of this regimen in these patients.
- Determine the progression-free survival of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the duration of response in patients treated with this regimen.
- Determine the time to treatment failure in patients treated with this regimen.
- Describe the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive vinflunine IV over 20 minutes on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every other course, and at the completion of study treatment.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450515
|Study Chair:||Alvaro Moreno, MD||Mayo Clinic|
|Investigator:||Philip J. Stella, MD||Ann Arbor Hematology Oncology Associates, PC at St. Joseph Mercy Cancer Center|