Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474903
Status:
COMPLETED
Last Update Posted:
2014-07-02
First Post:
2007-05-16
Brief Title:
Esomeprazole Magnesium With or Without Aspirin in Preventing Esophageal Cancer in Patients With Barrett Esophagus
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Double-Blinded Phase II Trial of Esomeprazole Versus Esomeprazole Two Doses of Aspirin in Barretts Esophagus Patients
Status:
COMPLETED
Status Verified Date:
2014-01
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:
This randomized phase II trial is studying the effect of esomeprazole magnesium and aspirin on tissue PGE2 levels compared with esomeprazole and placebo This type of chemoprevention treatment investigates the use of certain drugs to assess whether they assist in the prevention of cancer The use of esomeprazole magnesium with or without aspirin may help prevent esophageal cancer in patients with Barrett esophagus
Detailed Description:
PRIMARY OBJECTIVES
I To assess the effects of a 28 day intervention with aspirin 81 mg placebo orally PO once daily QD aspirin 325 mg placebo PO QD esomeprazole 40 mg PO BID versus aspirin 81 mg PO QD aspirin 325 mg placebo PO QD esomeprazole 40 mg PO BID versus aspirin 325 mg PO QD aspirin 81 mg placebo PO QD esomeprazole 40 mg PO BID on the absolute change in tissue prostaglandin E2 PGE2 concentration as determined from Barretts esophagus mucosal biopsy samples obtained pre- and post-intervention ie two pair-wise comparisons of two different doses of active aspirin regimens versus aspirin placebo group Specifically the two active aspirin esomeprazole arms will be independently analyzed to see if they significantly reduce the mean tissue PGE2 concentration from Pre- to Post-intervention as compared to the aspirin placebo esomeprazole arm
SECONDARY OBJECTIVES
I To determine if the change in the tissue PGE2 concentration decreases significantly in the aspirin placebo esomeprazole arm
II To compare the change in mean tissue PGE2 concentration between the two active intervention arms to determine which one appears the most promising for further testing
III To assess the effects of the three agents arms with respect to proliferation Ki-67 apoptosis caspase-3 expression COX-2 expression and p16 methylation using Pre- and Post-Intervention biopsy samples obtained from Barretts mucosal tissue
IV To evaluate all adverse events associated with each of the three intervention arms
V To provide exploratory summaries of PGE2 concentration values by patient subgroups of interest
VI To provide descriptive summaries of the esophagogastroduodenoscopy EGD results the rate of dysplasia adverse events and the Run-In Agent compliance on all participants that signed a consent form and started the Run-In phase of the trial
VII To establish a biospecimen repository archive for future correlative studies
OUTLINE This is a multicenter randomized double-blind placebo-controlled study Patients are stratified according to dysplasia status gender and length of Barrett segment of circumferential involvement 5 cm vs 5 cm Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive two oral placebos once daily and oral esomeprazole magnesium twice daily
ARM II Patients receive oral acetylsalicylic acid aspirin and oral placebo once daily and oral esomeprazole magnesium twice daily
ARM III Patients receive a higher-dose of oral aspirin higher than in arm II and a lower-dose of oral placebo lower than in arm II once daily and oral esomeprazole magnesium twice daily
In all arms treatment continues for 28 days in the absence of unacceptable toxicity Tissue samples are collected before and after treatment and examined for tissue-based biomarkers ie PGE_2 Ki-67 caspase-3 apoptosis and cyclooxygenase-2 by immunohistochemistry enzyme immunoassay Western blot and polymerase chain reaction
After completion of study therapy patients are followed 7 - 30 days
I To assess the effects of a 28 day intervention with aspirin 81 mg placebo orally PO once daily QD aspirin 325 mg placebo PO QD esomeprazole 40 mg PO BID versus aspirin 81 mg PO QD aspirin 325 mg placebo PO QD esomeprazole 40 mg PO BID versus aspirin 325 mg PO QD aspirin 81 mg placebo PO QD esomeprazole 40 mg PO BID on the absolute change in tissue prostaglandin E2 PGE2 concentration as determined from Barretts esophagus mucosal biopsy samples obtained pre- and post-intervention ie two pair-wise comparisons of two different doses of active aspirin regimens versus aspirin placebo group Specifically the two active aspirin esomeprazole arms will be independently analyzed to see if they significantly reduce the mean tissue PGE2 concentration from Pre- to Post-intervention as compared to the aspirin placebo esomeprazole arm
SECONDARY OBJECTIVES
I To determine if the change in the tissue PGE2 concentration decreases significantly in the aspirin placebo esomeprazole arm
II To compare the change in mean tissue PGE2 concentration between the two active intervention arms to determine which one appears the most promising for further testing
III To assess the effects of the three agents arms with respect to proliferation Ki-67 apoptosis caspase-3 expression COX-2 expression and p16 methylation using Pre- and Post-Intervention biopsy samples obtained from Barretts mucosal tissue
IV To evaluate all adverse events associated with each of the three intervention arms
V To provide exploratory summaries of PGE2 concentration values by patient subgroups of interest
VI To provide descriptive summaries of the esophagogastroduodenoscopy EGD results the rate of dysplasia adverse events and the Run-In Agent compliance on all participants that signed a consent form and started the Run-In phase of the trial
VII To establish a biospecimen repository archive for future correlative studies
OUTLINE This is a multicenter randomized double-blind placebo-controlled study Patients are stratified according to dysplasia status gender and length of Barrett segment of circumferential involvement 5 cm vs 5 cm Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive two oral placebos once daily and oral esomeprazole magnesium twice daily
ARM II Patients receive oral acetylsalicylic acid aspirin and oral placebo once daily and oral esomeprazole magnesium twice daily
ARM III Patients receive a higher-dose of oral aspirin higher than in arm II and a lower-dose of oral placebo lower than in arm II once daily and oral esomeprazole magnesium twice daily
In all arms treatment continues for 28 days in the absence of unacceptable toxicity Tissue samples are collected before and after treatment and examined for tissue-based biomarkers ie PGE_2 Ki-67 caspase-3 apoptosis and cyclooxygenase-2 by immunohistochemistry enzyme immunoassay Western blot and polymerase chain reaction
After completion of study therapy patients are followed 7 - 30 days
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-2009-00838 | REGISTRY | None | None |
| MAY04-4-01 | None | None | None |
| CDR0000544180 | None | None | None |
| MAYO-MAY04-4-01 | OTHER | None | None |
| MAY04-4-01 | OTHER | None | None |
| N01CN35000 | NIH | DCP | httpsreporternihgovquickSearchN01CN35000 |