Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014404
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2001-04-10
Brief Title:
Celecoxib in Treating Patients With Precancerous Lesions of the Mouth
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Double-Blind Placebo Controlled Randomized Study Of Celecoxib A Selective COX-2 Inhibitor In Oral Premalignant Lesions
Status:
COMPLETED
Status Verified Date:
2013-01
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 further development of precancerous lesions in the mouth
PURPOSE Randomized phase II trial to compare the effectiveness of different regimens of celecoxib in treating patients who have precancerous lesions in the mouth
PURPOSE Randomized phase II trial to compare the effectiveness of different regimens of celecoxib in treating patients who have precancerous lesions in the mouth
Detailed Description:
OBJECTIVES I Determine the efficacy of celecoxib in terms of clinical response and histological response in patients with oral premalignant lesions II Evaluate the safety of chronic multiple dosing of celecoxib in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to premalignant risk early vs advanced Patients in each stratum are randomized to 1 of 3 treatments arms Arm I Patients receive lower-dose oral celecoxib twice daily Arm II Patients receive higher-dose oral celecoxib twice daily Arm III Patients receive oral placebo twice daily Treatment continues in all 3 arms for 12 weeks in the absence of disease progression or unacceptable toxicity Patients are followed at 18 24 and 26 weeks
PROJECTED ACCRUAL A total of 84 patients 42 per stratum 14 per arm will be accrued for this study within 6 months
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to premalignant risk early vs advanced Patients in each stratum are randomized to 1 of 3 treatments arms Arm I Patients receive lower-dose oral celecoxib twice daily Arm II Patients receive higher-dose oral celecoxib twice daily Arm III Patients receive oral placebo twice daily Treatment continues in all 3 arms for 12 weeks in the absence of disease progression or unacceptable toxicity Patients are followed at 18 24 and 26 weeks
PROJECTED ACCRUAL A total of 84 patients 42 per stratum 14 per arm will be accrued for this study within 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSKCC-00111 | None | None | None |
| NCI-G01-1930 | None | None | None |