Paclitaxel Poliglumex and Capecitabine in Treating Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex 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 paclitaxel poliglumex together with capecitabine works in treating patients with metastatic breast cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of CT-2103 (Xyotax™) With Capecitabine as First-Line Chemotherapy for Patients With Metastatic Breast Cancer|
- Proportion of confirmed tumor response (complete and partial response) as assessed by RECIST criteria [ Designated as safety issue: No ]
- Survival time [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
|Study Start Date:||February 2006|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
- Assess the tumor response rate and adverse event profile in patients with metastatic, HER2 negative breast cancer treated with paclitaxel poliglumex (CT-2103; Xyotax™) and capecitabine.
- Examine the distributions of disease-free progression times and survival times in these patients.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel poliglumex IV (CT-2103; Xyotax™) over 10-20 minutes on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
|Investigator:||Edith A. Perez, MD||Mayo Clinic|
|Investigator:||Timothy Hobday, MD||Mayo Clinic|
|Study Chair:||Donald W. Northfelt, MD, FACP||Mayo Clinic|
|Investigator:||Daniel W. Visscher, MD||Mayo Clinic|
|Investigator:||Mark Rodacker, MD||Medcenter One Hospital Cancer Care Center|