NCT00062023

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether sulindac, aspirin, or ursodiol is more effective in preventing colorectal cancer. PURPOSE: This randomized phase II trial is studying how well sulindac works compared to aspirin or ursodiol in preventing colorectal cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2 colorectal-cancer

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

1.8 years

First QC Date

June 5, 2003

Last Update Submit

July 27, 2012

Conditions

Colorectal Cancer

Keywords

colorectal cancerstage I colon cancerstage II colon cancerstage III colon cancerstage IV colon cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage Change in Colorectal ACF Patients Treated with Sulindac, Aspirin or Ursodiol

    12 Months

Study Arms (4)

Arm I Sulindac

ACTIVE COMPARATOR

Oral sulindac twice daily.

Drug: Sulindac

Arm II Aspirin

ACTIVE COMPARATOR

Oral aspirin once daily.

Drug: Acetylsalicylic acid (Aspirin)

Arm III Ursodiol

ACTIVE COMPARATOR

Oral ursodiol three times daily.

Drug: Ursodiol

Arm IV: Sulindac Placebo

PLACEBO COMPARATOR

Oral sulindac placebo twice daily.

Other: Sulindac Placebo

Interventions

Acetylsalicylic acid (Aspirin)DRUG

Patients receive oral aspirin once daily for 12 months.

Also known as: Aspirin, USAN, ASA
Arm II Aspirin
SulindacDRUG

Patients receive oral sulindac twice daily for 12 months.

Also known as: Clinoril
Arm I Sulindac
UrsodiolDRUG

Patients receive oral ursodiol three times daily for 12 months.

Also known as: ursodeoxycholic acid, UDCA
Arm III Ursodiol
Sulindac PlaceboOTHER

Oral sulindac placebo twice daily.

Arm IV: Sulindac Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects, age 40-80 years
  • with \>5 colorectal ACF and a prior history of colorectal cancer defined as Dukes A/B1 carcinoma within 5 years of entry or any stage of colorectal cancer if at least 5 years post surgical resection (86 subjects)
  • with \>5 colorectal ACF and recent/current history of colorectal adenoma(s) defined as one of the following: one adenomatous polyp \>1cm or two or more adenomatous polyps of any size or one adenomatous polyp of any size and a documented history of adenomatous polyp(s) (86 subjects)
  • No elevated risk of colorectal cancer or adenomas (20 subjects)
  • Subjects will be permitted to use Nasonex but all other nasal steroids are prohibited. Subjects may change to Nasonex but must have discontinued previous nasal steroid use for at least 30 days prior to study randomization.
  • If participant is female and of childbearing potential, she must agree to use adequate contraception and must have a negative serum pregnancy test within 14 days prior to study drug administration
  • No use of investigational agent(s) within the last 3 months or at the discretion of the medical monitor
  • The subject will be allowed to proceed to randomization so long as all of the following laboratory criteria are met on baseline evaluation: Hgb \> 10.0 g/dl, platelet count \> 100,000/ul; WBC \> 3,000/ul; ALT \< 2 x upper limit of normal; AST \< 2 x upper limit of normal, and total bilirubin \<1.5mg/100ml.
  • Patients requiring use of hormone modulators such as Tamoxifen or Arimidex will be permitted to enroll providing they meet all of the eligibility criteria noted above

You may not qualify if:

  • Known diagnosis of FAP, hereditary non-polyposis colon cancer (HNPCC), or inflammatory bowel disease
  • History of hypersensitivity to COX-2 inhibitors, sulfonamides, NSAIDs , salicylates, or ursodeoxycholic acid
  • Use of NSAIDs, including aspirin, at any dose during the six months prior to study entry will require a three month washout period prior to eligibility beginning with the time of the last dose. Participants must be off all NSAIDs for three months prior to study entry. Individuals on cardioprotectant aspirin at any dose will not be eligible.
  • History of gastroduodenal ulcers documented endoscopically would preclude a patient from participation in the trial
  • Known inability to participate in the scheduled follow-up tests.
  • Significant medical or psychiatric problems which would make the patient a poor protocol candidate, in the opinion of the principal investigator.
  • "Unacceptable clinical risk" to proceed (based upon the subclinical discoveries made via baseline colonoscopy and biopsies).
  • Patient has undergone a total colectomy
  • Patient has received chemotherapy within the past 6 months of randomization into study. Topical chemotherapy will be assessed on a case-by-case basis. Any history of pelvic or rectal radiation therapy will exclude a patient from participating.
  • History of invasive carcinoma in the past five years (except patients with Dukes A/B1 carcinoma within 5 years of entry or any stage of colorectal cancer if at least 5 years post surgical resection)
  • Patients with rectal cancer are excluded except for transanal excision without radiation.
  • Patients with acute liver disease, unexplained transaminase elevations or a history of renal stones would be excluded.
  • Participants will not be permitted to be randomized into the trial if any of the following laboratory values are reported at baseline : Hgb \< 10.0 g/dl, platelet count \<100,000/ul; WBC \< 3,000/ul; ALT \> 2 x upper limit of normal; AST \> 2 x upper limit of normal, and total bilirubin \>1.5mg/100ml.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Interventions

AspirinSulindacUrsodeoxycholic Acid

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsIndenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDeoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsCholanes

Study Officials

  • Robert S. Bresalier, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2003

First Posted

June 6, 2003

Study Start

June 1, 2003

Primary Completion

April 1, 2005

Study Completion

May 1, 2006

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(1)