Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335504
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2006-06-08
Brief Title:
Atorvastatin Calcium Oligofructose-Enriched Inulin or Sulindac in Preventing Cancer in Patients at Increased Risk of Developing Colorectal Neoplasia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase II Trial of Atorvastatin RAFTILOSE Synergy 1 and Sulindac Among Patients at Increased Risk for Sporadic Colorectal Neoplasia
Status:
COMPLETED
Status Verified Date:
2016-12
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:
This randomized phase II trial is studying atorvastatin calcium to see how well it works compared to oligofructose-enriched inulin sulindac or a placebo in preventing cancer in patients at increased risk of developing colorectal neoplasia Chemoprevention is the use of certain drugs or substances to keep cancer from forming growing or coming back The use of atorvastatin calcium oligofructose-enriched inulin or sulindac may stop cancer from forming in patients at increased risk of colorectal neoplasia It is not yet known whether atorvastatin calcium oligofructose-enriched inulin or sulindac are more effective than a placebo in preventing cancer in patients at increased risk of developing colorectal neoplasia
Detailed Description:
PRIMARY OBJECTIVE
I Percent change in number of rectal aberrant cryptic foci ACF as measured by magnification chromoendoscopy
SECONDARY OBJECTIVES
I Screening for possible phase III testing II Effects on proliferation Ki67 expression and apoptosis caspase-3 expression as measured by biopsy samples obtained from normal-appearing rectal mucosa at baseline and after completion of study treatment III Correlation of endoscopic features with histologic characteristics of rectal ACF IV Observation of the natural history of rectal ACF in patients receiving placebo V Adverse events VI Utilization of a biospecimen repository archive
OUTLINE This is a multicenter prospective randomized partially blinded placebo-controlled study Patients are stratified according to history of prior surgical resection of the colon yes vs no and number of rectal aberrant cryptic foci ACF 5-9 vs 10 Patients are randomized to 1 of 4 treatment arms
ARM I Patients receive oral atorvastatin calcium once daily
ARM II Patients receive oral sulindac twice daily
ARM III blinded arm Patients receive oral oligofructose-enriched inulin Raftilose Synergy 1 twice daily
ARM IV blinded arm Patients receive an oral placebo twice daily
In all arms treatment continues for 6 months in the absence of unacceptable toxicity
Tissue samples are collected at baseline and at the completion of study treatment Tissue is examined by immunohistochemistry for proliferation Ki67 and apoptosis cleaved caspase-3
After completion of study treatment patients are followed at approximately 30 days
I Percent change in number of rectal aberrant cryptic foci ACF as measured by magnification chromoendoscopy
SECONDARY OBJECTIVES
I Screening for possible phase III testing II Effects on proliferation Ki67 expression and apoptosis caspase-3 expression as measured by biopsy samples obtained from normal-appearing rectal mucosa at baseline and after completion of study treatment III Correlation of endoscopic features with histologic characteristics of rectal ACF IV Observation of the natural history of rectal ACF in patients receiving placebo V Adverse events VI Utilization of a biospecimen repository archive
OUTLINE This is a multicenter prospective randomized partially blinded placebo-controlled study Patients are stratified according to history of prior surgical resection of the colon yes vs no and number of rectal aberrant cryptic foci ACF 5-9 vs 10 Patients are randomized to 1 of 4 treatment arms
ARM I Patients receive oral atorvastatin calcium once daily
ARM II Patients receive oral sulindac twice daily
ARM III blinded arm Patients receive oral oligofructose-enriched inulin Raftilose Synergy 1 twice daily
ARM IV blinded arm Patients receive an oral placebo twice daily
In all arms treatment continues for 6 months in the absence of unacceptable toxicity
Tissue samples are collected at baseline and at the completion of study treatment Tissue is examined by immunohistochemistry for proliferation Ki67 and apoptosis cleaved caspase-3
After completion of study treatment patients are followed at approximately 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 |
|---|---|---|---|
| P30CA015083 | NIH | DCP | httpsreporternihgovquickSearchP30CA015083 |
| NCI-2009-00837 | REGISTRY | None | None |
| CDR0000467755 | None | None | None |
| MAY03-1-03 | OTHER | None | None |
| MAY03-1-03 | OTHER | None | None |
| N01CN35000 | NIH | None | None |