Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023621
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2001-09-13
Brief Title:
Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
Sponsor:
University of California San Francisco
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Randomized Double-Blind Placebo-Controlled Clinical Trial of Celecoxib in Subjects With Basal Cell Nevus Syndrome
Status:
COMPLETED
Status Verified Date:
2007-07
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 of cancer The use of celecoxib may be an effective way to prevent the development of basal cell carcinoma
PURPOSE Randomized phase II trial to determine the effectiveness of celecoxib in preventing basal cell carcinoma in patients who have basal cell nevus syndrome
PURPOSE Randomized phase II trial to determine the effectiveness of celecoxib in preventing basal cell carcinoma in patients who have basal cell nevus syndrome
Detailed Description:
OBJECTIVES
Determine whether celecoxib prevents the development of basal cell carcinoma in patients with basal cell nevus syndrome
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 2 arms
Arm I Patients receive oral celecoxib twice daily
Arm II Patients receive oral placebo twice daily Treatment continues for 2 years in the absence of unacceptable toxicity
Patients are followed every 3 months for 3 years
PROJECTED ACCRUAL A total of 60 patients 30 per arm will be accrued for this study
Determine whether celecoxib prevents the development of basal cell carcinoma in patients with basal cell nevus syndrome
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are randomized to 1 of 2 arms
Arm I Patients receive oral celecoxib twice daily
Arm II Patients receive oral placebo twice daily Treatment continues for 2 years in the absence of unacceptable toxicity
Patients are followed every 3 months for 3 years
PROJECTED ACCRUAL A total of 60 patients 30 per arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-P01-0190 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068817 | REGISTRY | None | None |
| UCSF-H473-16531-02B | None | None | None |