Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT00258232
Status:
COMPLETED
Last Update Posted:
2013-04-08
First Post:
2005-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Celecoxib, Capecitabine, and Irinotecan in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA022453 | NIH | None | https://reporter.nih.gov/quic… | View |
| WSU-C-2424 | None | None | View |