Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006381
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2000-10-04
Brief Title:
Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Celecoxib in HER-2Neu Overexpressing Metastatic Breast Cancer Patients Who Have Failed Recombinant Humanized Anti-p 185HER Monoclonal Antibody Trastuzumab HERCEPTIN
Status:
COMPLETED
Status Verified Date:
2003-12
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 Celecoxib may be effective in preventing the further development of cancer Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining trastuzumab with celecoxib may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining celecoxib and trastuzumab in treating women who have metastatic breast cancer that has not responded to previous trastuzumab
PURPOSE Phase II trial to study the effectiveness of combining celecoxib and trastuzumab in treating women who have metastatic breast cancer that has not responded to previous trastuzumab
Detailed Description:
OBJECTIVES
Determine the efficacy of celecoxib and trastuzumab Herceptin in women with HER2neu-overexpressing metastatic breast cancer that is refractory to prior trastuzumab
Determine the safety of celecoxib in these patients
OUTLINE At least 3 weeks after the last dose of prior chemotherapy patients receive oral celecoxib twice daily Patients continue or restart trastuzumab Herceptin IV over 30-90 minutes weekly or every 3 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within approximately 9 months
Determine the efficacy of celecoxib and trastuzumab Herceptin in women with HER2neu-overexpressing metastatic breast cancer that is refractory to prior trastuzumab
Determine the safety of celecoxib in these patients
OUTLINE At least 3 weeks after the last dose of prior chemotherapy patients receive oral celecoxib twice daily Patients continue or restart trastuzumab Herceptin IV over 30-90 minutes weekly or every 3 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within approximately 9 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1869 | None | None | None |
| MSKCC-00078 | None | None | None |