Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-31 @ 7:24 AM
Study NCT ID:
NCT00335504
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2006-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
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:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2009-00837 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000467755 | None | None | View | |
| MAY03-1-03 | OTHER | Mayo Clinic | View | |
| MAY03-1-03 | OTHER | DCP | View | |
| N01CN35000 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |