Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290680
Status:
COMPLETED
Last Update Posted:
2018-04-10
First Post:
2006-02-09
Brief Title:
Bortezomib and Celecoxib in Treating Patients With Advanced Solid Tumors
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Phase I Trial of Bortezomib VELCADE and Celecoxib in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2018-04
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 Bortezomib and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving bortezomib together with celecoxib may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of bortezomib and celecoxib in treating patients with advanced solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of bortezomib and celecoxib in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose MTD of bortezomib and celecoxib in patients with advanced solid tumors
Secondary
Determine the overall pattern of toxicities associated with this combination including the emergence of any cumulative toxicities during multiple courses of this regimen
Describe the response rate and duration of response or disease stability during therapy in the subset of patients with measurable disease
Assess changes in plasmaserum sphingosine-1-phosphate ceramide and other markers of the apoptotic pathway before and during therapy
OUTLINE This is a dose-escalation study
Patients receive bortezomib IV on days 1 4 8 and 11 or days 1 8 15 22 and 29 and oral celecoxib twice daily on days 1-21 or 1-42 Courses repeat every 21 or 42 days in the absence of disease progression or unacceptable toxicity Patients are evaluated every 2 courses Patients achieving complete response CR receive 2 additional courses of therapy beyond CR
Cohorts of 3-6 patients receive escalating doses of bortezomib and celecoxib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
Primary
Determine the maximum tolerated dose MTD of bortezomib and celecoxib in patients with advanced solid tumors
Secondary
Determine the overall pattern of toxicities associated with this combination including the emergence of any cumulative toxicities during multiple courses of this regimen
Describe the response rate and duration of response or disease stability during therapy in the subset of patients with measurable disease
Assess changes in plasmaserum sphingosine-1-phosphate ceramide and other markers of the apoptotic pathway before and during therapy
OUTLINE This is a dose-escalation study
Patients receive bortezomib IV on days 1 4 8 and 11 or days 1 8 15 22 and 29 and oral celecoxib twice daily on days 1-21 or 1-42 Courses repeat every 21 or 42 days in the absence of disease progression or unacceptable toxicity Patients are evaluated every 2 courses Patients achieving complete response CR receive 2 additional courses of therapy beyond CR
Cohorts of 3-6 patients receive escalating doses of bortezomib and celecoxib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 36 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 |
|---|---|---|---|
| MILLENNIUM-100825 | None | None | None |
| MUSC-I065-341-03 | None | None | None |