Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061906
Status:
COMPLETED
Last Update Posted:
2014-02-11
First Post:
2003-06-05
Brief Title:
Celecoxib in Treating Patients With Progressive Metastatic Differentiated Thyroid Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Study Of Celecoxib In Metastatic Differentiated Thyroid Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-02
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 thyroid cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth
PURPOSE Phase II trial to study the effectiveness of celecoxib in treating patients who have progressive metastatic differentiated thyroid cancer
PURPOSE Phase II trial to study the effectiveness of celecoxib in treating patients who have progressive metastatic differentiated thyroid cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of celecoxib in terms of progression-free survival in patients with progressive metastatic differentiated thyroid carcinoma
Correlate cyclooxygenase COX-2 protein expression in tumor biopsies by immunohistochemistry with clinical response in patients treated with this drug
OUTLINE Patients receive oral celecoxib twice daily beginning on day 1 Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 3 additional months of therapy beyond documentation of CR
Patients are followed at 4-8 weeks
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study within approximately 6 months
Determine the efficacy of celecoxib in terms of progression-free survival in patients with progressive metastatic differentiated thyroid carcinoma
Correlate cyclooxygenase COX-2 protein expression in tumor biopsies by immunohistochemistry with clinical response in patients treated with this drug
OUTLINE Patients receive oral celecoxib twice daily beginning on day 1 Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 3 additional months of therapy beyond documentation of CR
Patients are followed at 4-8 weeks
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study within approximately 6 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