Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101062
Status:
TERMINATED
Last Update Posted:
2011-06-08
First Post:
2005-01-07
Brief Title:
Letrozole and Celecoxib in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Phase II Study of Letrozole Femara and Celecoxib Celebrex in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study drug unavailable
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Estrogen can cause the growth of breast cancer cells Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor Giving letrozole with celecoxib may kill more tumor cells
PURPOSE This phase II trial is studying how well letrozole and celecoxib work in treating postmenopausal women with locally advanced or metastatic breast cancer
PURPOSE This phase II trial is studying how well letrozole and celecoxib work in treating postmenopausal women with locally advanced or metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in postmenopausal women with hormone receptor-positive locally advanced or metastatic adenocarcinoma of the breast treated with letrozole and celecoxib as first-line therapy
Secondary
Determine the time to disease progression and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Compare cyclooxygenase activity in blood and tumor cells from these patients before and after treatment with this regimen
Determine the effect of this regimen on aromatase activity tumor proliferation and angiogenesis in tumor samples from these patients
OUTLINE This is a multicenter study
Patients receive oral letrozole once daily and oral celecoxib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 45-72 patients will be accrued for this study
Primary
Determine the response rate in postmenopausal women with hormone receptor-positive locally advanced or metastatic adenocarcinoma of the breast treated with letrozole and celecoxib as first-line therapy
Secondary
Determine the time to disease progression and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Compare cyclooxygenase activity in blood and tumor cells from these patients before and after treatment with this regimen
Determine the effect of this regimen on aromatase activity tumor proliferation and angiogenesis in tumor samples from these patients
OUTLINE This is a multicenter study
Patients receive oral letrozole once daily and oral celecoxib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 45-72 patients will be accrued for this study
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 |
|---|---|---|---|
| UMDNJ-4761 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA072720 |
| P30CA072720 | NIH | None | None |
| CINJ-NJ1103 | None | None | None |
| CINJ-5076v3 | None | None | None |
| CINJ-040402 | None | None | None |