Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075673
Status:
TERMINATED
Last Update Posted:
2020-07-27
First Post:
2004-01-09
Brief Title:
Vinorelbine and Celecoxib in Treating Women With Relapsed or Metastatic Breast Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Study of Weekly Administration of Oral Navelbine in Combination With the COX-2 Inhibitor Celebrex in Relapsed andor Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2020-07
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 stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Drugs used in chemotherapy such as vinorelbine work in different ways to stop tumor cells from dividing so they stop growing or die Combining vinorelbine with celecoxib may kill more tumor cells
PURPOSE Phase I trial to determine the effectiveness of combining vinorelbine with celecoxib in treating women who have relapsed or metastatic breast cancer
PURPOSE Phase I trial to determine the effectiveness of combining vinorelbine with celecoxib in treating women who have relapsed or metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of vinorelbine and celecoxib in women with relapsed or metastatic breast cancer
Determine the safety profile of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive oral celecoxib twice daily on days 1-21 and oral vinorelbine on days 7 14 and 21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of celecoxib and vinorelbine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 12-18 patients will be accrued for this study
Determine the maximum tolerated dose of vinorelbine and celecoxib in women with relapsed or metastatic breast cancer
Determine the safety profile of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive oral celecoxib twice daily on days 1-21 and oral vinorelbine on days 7 14 and 21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of celecoxib and vinorelbine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 12-18 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