Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258232
Status:
COMPLETED
Last Update Posted:
2013-04-08
First Post:
2005-11-22
Brief Title:
Celecoxib Capecitabine and Irinotecan in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase II Study of Celecoxib Capecitabine and Irinotecan in Patients With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-04
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 Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as capecitabine and irinotecan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving celecoxib together with capecitabine and irinotecan may kill more tumor cells
PURPOSE This phase II trial is studying how well giving celecoxib together with capecitabine and irinotecan works in treating patients with recurrent or metastatic colorectal cancer
PURPOSE This phase II trial is studying how well giving celecoxib together with capecitabine and irinotecan works in treating patients with recurrent or metastatic colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the objective response rate in patients with locally recurrent or metastatic colorectal cancer treated with celecoxib capecitabine and irinotecan
Secondary
Determine the time to progression in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the overall survival of patients treated with this regimen
Determine the time to treatment failure in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral celecoxib twice daily on days -7 to 21 during course 1 and on days 1-21 in all subsequent courses Patients also receive oral capecitabine twice daily on days 1-14 and irinotecan IV over 30 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete or partial response after 4 courses may temporarily discontinue treatment for no more than 4 weeks
After completion of study treatment patients are followed every 6 months for survival
PROJECTED ACCRUAL A total of 21-44 patients will be accrued for this study within 7-18 months
Primary
Determine the objective response rate in patients with locally recurrent or metastatic colorectal cancer treated with celecoxib capecitabine and irinotecan
Secondary
Determine the time to progression in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the overall survival of patients treated with this regimen
Determine the time to treatment failure in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive oral celecoxib twice daily on days -7 to 21 during course 1 and on days 1-21 in all subsequent courses Patients also receive oral capecitabine twice daily on days 1-14 and irinotecan IV over 30 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete or partial response after 4 courses may temporarily discontinue treatment for no more than 4 weeks
After completion of study treatment patients are followed every 6 months for survival
PROJECTED ACCRUAL A total of 21-44 patients will be accrued for this study within 7-18 months
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 |
|---|---|---|---|
| WSU-C-2424 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |