S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide 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 chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with capecitabine works in treating women with stage IV breast cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer|
- Response rate (complete and partial, confirmed and unconfirmed) [ Time Frame: two years ] [ Designated as safety issue: No ]
- Progression-free survival and overall survival [ Time Frame: two years ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2005|
|Study Completion Date:||August 2009|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Experimental: cyclophosphamide and capecitabine
cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
Other Name: cytoxan
- Determine the response rate (complete and partial, confirmed and unconfirmed) in women with stage IV breast cancer treated with oral cyclophosphamide and oral capecitabine.
- Determine the progression-free survival and overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral cyclophosphamide once daily on days 1-14 and oral capecitabine twice daily on days 8-21. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then at weeks 7, 13, 19, and 25.
After completion of study treatment, patients are followed every 3 months for up to 2 years.
PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study within 4 years.
Show 145 Study Locations
|Study Chair:||Anne F. Schott, MD||University of Michigan Cancer Center|
|Study Chair:||Kathy S. Albain, MD||Loyola University|