Imatinib Mesylate and Capecitabine in Treating Women With Progressive Stage IV Breast Cancer
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining imatinib mesylate with capecitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with capecitabine works in treating women with progressive stage IV breast cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Of Imatinib Mesylate (Gleevec®) (NSC-716051) In Combination With Capecitabine (Xeloda®) (NSC-712807) In Metastatic Breast Cancer|
- Confirmed response rate (complete and partial) [ Designated as safety issue: No ]
- Progression-free survival at 6 months [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Correlation of c-kit and platelet-derived growth factor receptor expression with estrogen and progesterone receptor status, response, survival, and time to disease progression [ Designated as safety issue: No ]
|Study Start Date:||June 2004|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
- Determine the confirmed complete and partial response rate in women with progressive stage IV adenocarcinoma of the breast treated with imatinib mesylate and capecitabine.
- Determine the 6-month progression-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Correlate, preliminarily, c-kit and platelet-derived growth factor receptor expression with estrogen and progesterone receptor status, response, survival, and time to disease progression in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate* once daily on days 1-21 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
NOTE: *If the patient tolerates the starting dose of imatinib mesylate in course 1, the dose will be increased in subsequent courses.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 25-70 patients (25-45 patients with measurable disease and 25 with non-measurable disease) will be accrued for this study within 2 years.
|Study Chair:||Helen K. Chew, MD||University of California, Davis|
|Study Chair:||Kathy S. Albain, MD||Loyola University|