Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027976
Status:
WITHDRAWN
Last Update Posted:
2013-08-05
First Post:
2001-12-07
Brief Title:
Celecoxib in Preventing Skin Cancer in Patients With Actinic Keratoses
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
A Phase IIIII Randomized Double-Blind Placebo-Controlled Clinical Trial Of Celecoxib In Subjects With Actinic Keratoses
Status:
WITHDRAWN
Status Verified Date:
2012-11
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 Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer The use of celecoxib may be an effective way to prevent actinic keratoses
PURPOSE Randomized phase IIIII trial to determine the effectiveness of celecoxib in preventing skin cancer in patients who have actinic keratoses
PURPOSE Randomized phase IIIII trial to determine the effectiveness of celecoxib in preventing skin cancer in patients who have actinic keratoses
Detailed Description:
OBJECTIVES
Compare celecoxib vs placebo in terms of preventing the development of new actinic keratoses in patients with actinic keratoses
Compare these treatment regimens in terms of inducing regression of actinic keratoses in these patients
Determine the safety of this drug in these patients
Compare the effect of these treatment regimens on potential surrogate end-point biomarkers in areas of actinic keratosis sun-exposed skin and non-sun-exposed skin and correlate these biomarkers with clinical outcome in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral celecoxib twice daily for 9 months in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral placebo as in arm I Patients are followed at 2 months after completing treatment
PROJECTED ACCRUAL A total of 240 patients 120 per treatment arm will be accrued for this study
Compare celecoxib vs placebo in terms of preventing the development of new actinic keratoses in patients with actinic keratoses
Compare these treatment regimens in terms of inducing regression of actinic keratoses in these patients
Determine the safety of this drug in these patients
Compare the effect of these treatment regimens on potential surrogate end-point biomarkers in areas of actinic keratosis sun-exposed skin and non-sun-exposed skin and correlate these biomarkers with clinical outcome in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral celecoxib twice daily for 9 months in the absence of disease progression or unacceptable toxicity
Arm II Patients receive oral placebo as in arm I Patients are followed at 2 months after completing treatment
PROJECTED ACCRUAL A total of 240 patients 120 per treatment arm 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 |
|---|---|---|---|
| NCI-P01-0197 | None | None | None |
| UAB-9833 | None | None | None |
| UAB-NQ401A4009 | None | None | None |
| UAB-NQ49902009 | None | None | None |
| NCI-P00-0161 | None | None | None |