Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003076
Status:
COMPLETED
Last Update Posted:
2012-12-19
First Post:
1999-11-01
Brief Title:
Eflornithine to Prevent Cancer in Patients With Barretts Esophagus
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
Phase IIb Chemoprevention Trial of Difluoromethylornithine DFMO in Human Subjects With Intestinal-type Barretts Esophagus
Status:
COMPLETED
Status Verified Date:
2012-12
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 drugs to try and prevent the development or recurrence of cancer It is not known whether eflornithine is effective in preventing cancer in patients with Barretts esophagus
PURPOSE Randomized double-blinded phase II trial to study the effectiveness of eflornithine in preventing cancer in patients with Barretts esophagus
PURPOSE Randomized double-blinded phase II trial to study the effectiveness of eflornithine in preventing cancer in patients with Barretts esophagus
Detailed Description:
OBJECTIVES I Determine whether oral eflornithine DFMO given in this study will cause significant reduction of the Ki67 labelling index in subjects with intestinal type Barretts esophagus and low grade dysplastic Barretts esophagus II Determine whether oral DFMO will alter the pathology and morphology of Barretts esophagus III Determine whether there is a difference in cellular DNA ploidy andor nuclear or nucleolar morphometry in patients with dysplastic Barretts esophagus and nondysplastic intestinal type Barretts esophagus compared to normal gastric fundic mucosa Determine whether DFMO modulates changes in these surrogate endpoint biomarkers towards normal mucosal values IV Determine whether cells demonstrating nuclear p53 protein accumulation are either lost or undergo a change in cellular distribution following treatment of patients with dysplastic Barretts mucosa with DFMO V Determine whether DFMO modulates changes in growth factor or oncogene expression in dysplastic Barretts esophagus and nondysplastic intestinal type Barretts esophagus VI Determine whether pathologic or biologic surrogate modulation occurring during 6 months of DFMO treatment reverts 6 months after treatment is discontinued
OUTLINE This is a randomized placebo controlled double blind prevention study Patients are initially stratified by dysplasia status at baseline metaplastic vs low grade dysplastic and treatment group placebo vs eflornithine Patients are randomized to receive daily doses of eflornithine DFMO or placebo for 26 weeks At 0 4 8 12 16 20 and 26 weeks there are toxicity and adherence evaluations and at weeks 26 and 52 patients have follow-up endoscopies
PROJECTED ACCRUAL A total of a 152 evaluable patients will be accrued in this study
OUTLINE This is a randomized placebo controlled double blind prevention study Patients are initially stratified by dysplasia status at baseline metaplastic vs low grade dysplastic and treatment group placebo vs eflornithine Patients are randomized to receive daily doses of eflornithine DFMO or placebo for 26 weeks At 0 4 8 12 16 20 and 26 weeks there are toxicity and adherence evaluations and at weeks 26 and 52 patients have follow-up endoscopies
PROJECTED ACCRUAL A total of a 152 evaluable patients will be accrued in 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-P97-0094 | Other Identifier | University of Michigan Cancer Center PRC | httpsreporternihgovquickSearchP30CA046592 |
| P30CA046592 | NIH | None | None |
| CCUM-9555 | OTHER | None | None |