Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087152
Status:
COMPLETED
Last Update Posted:
2014-06-09
First Post:
2004-07-08
Brief Title:
S0338 Imatinib Mesylate and Capecitabine in Treating Women With Progressive Stage IV Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial Of Imatinib Mesylate Gleevec NSC-716051 In Combination With Capecitabine Xeloda NSC-712807 In Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000372950 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| U10CA032102 | NIH | None | None |
| S0338 | OTHER | None | None |