Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070057
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2003-10-03
Brief Title:
Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Exploratory Open-Label Phase I Pharmacodynamic Study of COX-2 Inhibition With Celecoxib Celebrex and Aromatase Activity in Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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:
This randomized phase I trial is studying the side effects of celecoxib in treating postmenopausal women with invasive breast cancer who are scheduled to undergo surgery at Memorial Sloan-Kettering Cancer Center Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Detailed Description:
PRIMARY OBJECTIVES
I Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery
SECONDARY OBJECTIVES
I Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase COX-2 and HER-2neu and estrogen receptor status in these patients
II Determine the effect of this drug on histology Ki67 RNA expression profile by microarray analysis PI3-K AKT and ERK12 MAP kinase activities and PGE_2 levels in these patients
III Determine whether any observed biological effect of this drug is dose-dependent in these patients
IV Identify collateral targets COX-2-independent of this drug in these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive oral celecoxib twice daily for 1-3 weeks according to the duration between biopsy and surgery in the absence of unacceptable toxicity
Arm II Patients receive a higher dose of oral celecoxib as in arm I
Arm III Patients do not receive treatment
All patients undergo definitive surgery
PROJECTED ACCRUAL A total of 75 patients 25 per treatment arm will be accrued for this study within 2-3 years
I Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery
SECONDARY OBJECTIVES
I Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase COX-2 and HER-2neu and estrogen receptor status in these patients
II Determine the effect of this drug on histology Ki67 RNA expression profile by microarray analysis PI3-K AKT and ERK12 MAP kinase activities and PGE_2 levels in these patients
III Determine whether any observed biological effect of this drug is dose-dependent in these patients
IV Identify collateral targets COX-2-independent of this drug in these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive oral celecoxib twice daily for 1-3 weeks according to the duration between biopsy and surgery in the absence of unacceptable toxicity
Arm II Patients receive a higher dose of oral celecoxib as in arm I
Arm III Patients do not receive treatment
All patients undergo definitive surgery
PROJECTED ACCRUAL A total of 75 patients 25 per treatment arm will be accrued for this study within 2-3 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 |
|---|---|---|---|
| NCI-2012-01441 | REGISTRY | None | None |
| CDR0000329919 | None | None | None |
| MSKCC-03027 | OTHER | None | None |
| N01-CN-35112 | OTHER | None | None |
| P30CA008748 | NIH | None | None |
| N01CN35112 | OTHER_GRANT | US NIH GrantContract Award Number | httpsreporternihgovquickSearchP30CA008748 |