Atorvastatin Calcium, Oligofructose-Enriched Inulin, or Sulindac in Preventing Cancer in Patients at Increased Risk of Developing Colorectal Neoplasia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colon Cancer Precancerous Condition Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I (atorvastatin calcium)

Patients receive oral atorvastatin once daily.

Group Type EXPERIMENTAL

atorvastatin calcium

Intervention Type DRUG

Given orally

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Arm II (sulindac)

Patients receive oral sulindac twice daily.

Group Type EXPERIMENTAL

sulindac

Intervention Type DRUG

Given orally

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Arm III (oligofructose-enriched inulin)

Patients receive oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.

Group Type EXPERIMENTAL

oligofructose-enriched inulin

Intervention Type DRUG

Given orally

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Arm IV (placebo)

Patients receive an oral placebo twice daily.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Given orally

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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oligofructose-enriched inulin

Given orally

Intervention Type DRUG

sulindac

Given orally

Intervention Type DRUG

placebo

Given orally

Intervention Type DRUG

atorvastatin calcium

Given orally

Intervention Type DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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Beneo Synergy 1 Synergy 1 Aflodac Algocetil Clinoril SULIN PLCB CI-981 Lipitor

Eligibility Criteria

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Inclusion Criteria

* No other concurrent investigational agents
* No planned (or likely to require) clinically indicated colonoscopy or flexible sigmoidoscopy during study treatment
* Bilirubin =\< 1.5 times ULN
* Hemoglobin \>= lower limit of normal
* AST =\< 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase =\< 1.5 times ULN

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No