Colorectal CancerPhase 2NCT00062023
Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer
A Phase 2 study testing Acetylsalicylic acid (Aspirin), Sulindac and Ursodiol in people with Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Acetylsalicylic acid (Aspirin), Sulindac and Ursodiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to May 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Show all 13Show fewer
- "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.
Trial locations and contacts
1 site in 1 country.
United States1 site
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
About this study
Official title: Phase II Study Of Colorectal ACF Screening, Regression And Prevention In High Risk Participants
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.
Read the detailed description
OBJECTIVES:
- Determine the percentage change in colorectal aberrant crypt foci (ACF) in patients with a history of colorectal cancer or at high risk for colorectal cancer when treated with sulindac vs aspirin vs ursodiol.
- Determine the safety and efficacy of these drugs, in terms of ability to cause regression of existing colorectal ACF and prevent new ACF development, in these patients.
OUTLINE: This is a partially blinded, randomized, placebo-controlled study. Patients are stratified according to colorectal neoplasia (adenoma vs carcinoma). Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive oral sulindac twice daily.
- Arm II: Patients receive oral aspirin once daily.
- Arm III: Patients receive oral ursodiol three times daily.
- Arm IV: Patients receive oral sulindac placebo twice daily. In all arms, treatment continues for 12 months in the absence of disease progression or unacceptable toxicity.
Patients undergo a colonoscopy at baseline and at the end of treatment.
Patients are followed at 2 months after the end of treatment.
PROJECTED ACCRUAL: A total of 172 patients (43 per treatment arm) with a history of colorectal cancer or adenomas will be accrued for this study. A total of 20 additional patients with no elevated risk of colorectal neoplasia will be accrued, but not randomized, for this study.
- Conditions
- Colorectal Cancer
- Being tested
- Acetylsalicylic acid (Aspirin), Sulindac, Ursodiol, Sulindac Placebo
- Keywords
- colorectal cancer, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acid (Aspirin)Drug
Also called Aspirin, USAN, ASA
Patients receive oral aspirin once daily for 12 months.
SulindacDrug
Also called Clinoril
Patients receive oral sulindac twice daily for 12 months.
UrsodiolDrug
Also called ursodeoxycholic acid, UDCA
Patients receive oral ursodiol three times daily for 12 months.
Sulindac PlaceboOther
Oral sulindac placebo twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Arm I Sulindac | Active comparator | Oral sulindac twice daily. Receives: Drug: Sulindac |
| Arm II Aspirin | Active comparator | Oral aspirin once daily. Receives: Drug: Acetylsalicylic acid (Aspirin) |
| Arm III Ursodiol | Active comparator | Oral ursodiol three times daily. Receives: Drug: Ursodiol |
| Arm IV: Sulindac Placebo | Placebo comparator | Oral sulindac placebo twice daily. Receives: Other: Sulindac Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Colorectal ACF Patients Treated with Sulindac, Aspirin or Ursodiol
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2003 (estimated)
- Study startJun 2003
- Primary completionApr 2005
- Study completionMay 2006
Why it stopped: Study closed by the NCI.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert S. Bresalier, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062023
- Sponsor's protocol ID
- ID01-454
- Other IDs
- P30CA016672, MDA-ID-01454, CDR0000304433
- Status last verified
- Jul 2012
- First submitted
- 5 Jun 2003
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Of Colorectal ACF Screening, Regression And Prevention In High Risk Participants
- ClinicalTrials.gov ID
- NCT00062023
- Acronym / sponsor ID
- ID01-454
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed by the NCI.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2003
- Primary completion
- Apr 2005 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 6 Jun 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Determine the percentage change in colorectal aberrant crypt foci (ACF) in patients with a history of colorectal cancer or at high risk for colorectal cancer when treated with sulindac vs aspirin vs ursodiol.
- Determine the safety and efficacy of these drugs, in terms of ability to cause regression of existing colorectal ACF and prevent new ACF development, in these patients.
OUTLINE: This is a partially blinded, randomized, placebo-controlled study. Patients are stratified according to colorectal neoplasia (adenoma vs carcinoma). Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive oral sulindac twice daily.
- Arm II: Patients receive oral aspirin once daily.
- Arm III: Patients receive oral ursodiol three times daily.
- Arm IV: Patients receive oral sulindac placebo twice daily. In all arms, treatment continues for 12 months in the absence of disease progression or unacceptable toxicity.
Patients undergo a colonoscopy at baseline and at the end of treatment.
Patients are followed at 2 months after the end of treatment.
PROJECTED ACCRUAL: A total of 172 patients (43 per treatment arm) with a history of colorectal cancer or adenomas will be accrued for this study. A total of 20 additional patients with no elevated risk of colorectal neoplasia will be accrued, but not randomized, for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I Sulindac | Active comparator | Drug: SulindacOral sulindac twice daily. |
| Arm II Aspirin | Active comparator | Drug: Acetylsalicylic acid (Aspirin)Oral aspirin once daily. |
| Arm III Ursodiol | Active comparator | Drug: UrsodiolOral ursodiol three times daily. |
| Arm IV: Sulindac Placebo | Placebo comparator | Other: Sulindac PlaceboOral sulindac placebo twice daily. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic acid (Aspirin)Also: Aspirin, USAN, ASAPatients receive oral aspirin once daily for 12 months. | Drug | Arm II Aspirin |
| SulindacAlso: ClinorilPatients receive oral sulindac twice daily for 12 months. | Drug | Arm I Sulindac |
| UrsodiolAlso: ursodeoxycholic acid, UDCAPatients receive oral ursodiol three times daily for 12 months. | Drug | Arm III Ursodiol |
| Sulindac PlaceboOral sulindac placebo twice daily. | Other | Arm IV: Sulindac Placebo |
Primary outcome
Percentage Change in Colorectal ACF Patients Treated with Sulindac, Aspirin or Ursodiol
Time frame: 12 Months
Results and safety
The study was stopped early (reason given: Study closed by the NCI.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- UT MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S. Bresalier, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetylsalicylic acid (Aspirin), Sulindac and Ursodiol in people with Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study closed by the NCI.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Colorectal ACF Patients Treated with Sulindac, Aspirin or Ursodiol (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2012.