Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006079
Status:
COMPLETED
Last Update Posted:
2018-10-25
First Post:
2000-08-03
Brief Title:
Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Randomized Double-Blind Study of Alpha-Difluromethylornithine DFMO Versus Placebo in Patients With Cervical Intraepithelial Neoplasia CIN Grade 2-3
Status:
COMPLETED
Status Verified Date:
2018-10
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 eflornithine may be an effective way to prevent the recurrence of or further development of cervical cancer
PURPOSE Randomized phase II trial to determine the effectiveness of eflornithine in preventing cervical cancer in patients who have cervical intraepithelial neoplasia
PURPOSE Randomized phase II trial to determine the effectiveness of eflornithine in preventing cervical cancer in patients who have cervical intraepithelial neoplasia
Detailed Description:
OBJECTIVES I Compare the efficacy of eflornithine versus placebo in causing regression in patients with cervical intraepithelial neoplasia II Compare the qualitative and quantitative toxicities of these treatment regimens in these patients III Establish the biochemical tissue markers of DNA content PCNA the ras oncogene EGFR and keratin and involucrin as intermediate biomarker end points for squamous carcinogenesis in these patients
OUTLINE This is a randomized double blind multicenter study Patients are randomized to one of three treatment arms Arm I-II Patients receive one of two different doses of oral eflornithine daily Arm III Patients receive oral placebo daily Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity Patients are followed at 28 days and then at 6 12 18 and 24 months
PROJECTED ACCRUAL A total of 180 patients 60 per treatment arm will be accrued for this study
OUTLINE This is a randomized double blind multicenter study Patients are randomized to one of three treatment arms Arm I-II Patients receive one of two different doses of oral eflornithine daily Arm III Patients receive oral placebo daily Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity Patients are followed at 28 days and then at 6 12 18 and 24 months
PROJECTED ACCRUAL A total of 180 patients 60 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 |
|---|---|---|---|
| P30CA016672 | NIH | None | None |
| MDA-ID-92026 | OTHER | None | None |
| NCI-P00-0149 | None | None | None |
| CDR0000067921 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |