Adenomatous PolypPhase 2NCT00983580
Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer
A Phase 2 study testing Aspirin, Eflornithine and Laboratory Biomarker Analysis in people with Adenomatous Polyp, run by National Cancer Institute (NCI) at 3 sites in United States.
Trial summary
This phase II trial is studying how well giving acetylsalicylic acid together with eflornithine works in treating patients at high risk for colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acetylsalicylic acid and eflornithine may prevent colorectal cancer. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Adenomatous Polyp
- What is being tested?
- Aspirin, Eflornithine and Laboratory Biomarker Analysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Aug 2009to 13 Aug 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current or prior advanced adenomas
- Advanced adenomas are defined as subject with polyps >= 1 cm, tubulovillous adenomas (25-75 percent villous features), villous adenomas (> 75 percent villous), or high-grade dysplasia
- Prior colon cancer (>= 3 years out from invasive cancer)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Ability to under and the willingness to sign a written informed consent document
- Willingness to provide mandatory tissue for research purposes
Show all 16Show fewer
- Negative pregnancy test =< 7 days prior to randomization
- Hemoglobin (Hgb) within normal limits for institution/lab
- Platelet count >= 100,000/ul
- White blood cell count (WBC) >= 3,000/ul
- Alanine aminotransferase (ALT) =< 2 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) =< 2 x institutional ULN
- Total bilirubin =< 1.5 x institutional ULN
- Serum calcium =< institutional ULN
- Serum creatinine =< 1.5 x institutional ULN
- Colonoscopy =< 45 days prior to randomization with removal of all adenomas or polyps >= 2 mm in size
Who cannot join
- Any history of current or prior rectal cancer
- Known diagnosis of colon heritable cancer syndrome (familial adenomatous polyposis [FAP], hereditary nonpolyposis colorectal cancer [HNPCC]) or inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- Inability to swallow pills
- Bleeding diathesis
- New diagnosis of carcinoma
- History of hypersensitivity to COX-2 inhibitors, sulfonamides, nonsteroidal antiinflammatory drugs (NSAIDs), salicylates, or ursodeoxycholic acid
Show all 24Show fewer
- History of gastroduodenal ulcers documented =< 1 year
- Known inability to participate in the scheduled follow-up tests
- Significant medical or psychiatric problems which would make the subject a poor protocol candidate, in the opinion of the treating physician
- Total colectomy
- Patients with a colostomy
- History of pelvic or rectal radiation therapy
- History of invasive carcinoma =< 5 years (except subjects with Dukes A/B1 carcinoma =< 5 years prior to pre-registration or any stage of colon cancer if >= 3 years post surgical resection)
- Acute liver disease, unexplained transaminase elevations, or elevated serum calcium
- History of allergic reactions attributed to compounds of similar chemical composition to the study agents
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
- Concomitant corticosteroids or anticoagulants needed on a regular or predictable intermittent basis
- New diagnosis of invasive carcinoma
- Use of non-study investigational agent(s) =< 3 months prior to randomization
- Chemotherapy =< 6 months prior to randomization (Note: topical chemotherapy will be assessed on a case-by-case basis)
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Regular use of NSAIDs =< 6 weeks prior to randomization, defined as a frequency of 7 consecutive days (1 week) for > 3 weeks (Exception: low dose aspirin [81 mg] for those subjects who are chronic users of aspirin prior to the beginning of the study)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Illinois College of Medicine - Chicago
Chicago, Illinois, 60612
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Randomized Phase II Trial of Aspirin and Difluoromethylornithine (DFMO) in Patients at High Risk of Colorectal Cancer
This phase II trial is studying how well giving acetylsalicylic acid together with eflornithine works in treating patients at high risk for colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acetylsalicylic acid and eflornithine may prevent colorectal cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- The proportion of subjects with an adenoma recurrence at the 1-year follow-up colonoscopy exam. This adenoma recurrence rate for difluoromethylornithine (DFMO) (eflornithine) + aspirin will be compared to double placebo to see if there is improvement in the adenoma recurrence rate in this patient population.
SECONDARY OBJECTIVES:
- To determine the relative tolerability and safety of the treatment regimens administered for 12 months.
II. To determine the effect of the study drugs (aspirin [acetylsalicylic acid] + DFMO) and placebo with respect to proliferation (Ki67 labeling index), apoptosis (caspase-3 expression assay), and drug effect markers (COX-1, -2, polyamines, PGE2) from adenomas, aberrant crypt focus (ACF) and normal-appearing mucosa using pre- and 12-month post-intervention tissue biopsy samples.
III. To estimate the percentage change in rectal ACF number, as determined by magnifying colonoscopy in subjects treated for 12 months with placebo or study drugs (aspirin +DFMO) by comparing % change in drug versus placebo arms.
IV. To characterize ACF based on three criteria (ACF size [crypt number < 50 or >= 50], crypt morphology characteristics, and histology) of ACF and to correlate such characteristics with the intervention (vs placebo). Also, to evaluate the natural history of ACF over 1-year on placebo.
- To correlate the 12-month measurements of ACF size (# crypts/ACF), number, morphology, and histopathology with the adenoma recurrence data at 12 and 36 months; correlate the 12-month % (and actual) change in ACF size and number with the 12- and 36-month adenoma recurrence rate; and correlate the adenoma recurrence data at 1 year with the adenoma recurrence data at 3 years.
TERTIARY OBJECTIVES:
- To explore the effects of the study agents on a focused panel of tissue biomarkers in pre- and post-intervention biopsy samples from recurrent adenomas, rectal ACF, and adjacent normal-appearing mucosa among subjects enrolled in the phase II clinical trial.
II. To determine if cleaved capase-3 expression can improve the detection of apoptotic cells by recognizing cellular commitment to apoptosis prior to late nuclear morphologic features and correlate with apoptotic regulatory proteins, histology, and treatment response.
III. To determine the effects of aspirin on its biochemical targets COX-1, -2, and prostaglandin E2, and polyamine levels in subjects receiving DFMO.
IV. To examine COX-2-dependent genes (i.e., Bcl-2 and DR5) in adenomas and ACF that have been shown to regulate the intrinsic mitochondrial and extrinsic death receptor-mediated apoptotic pathways in vitro and in vivo.
- To perform expression profiling of adenomas or ACF and to relate such date to ACF histology, size/morphology, modulation by chemopreventive agents, and subsequent adenoma recurrence rates.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive acetylsalicylic acid orally (PO) once daily and eflornithine PO twice daily on days 1-28.
ARM II: Patients receive placebo PO three times daily on days 1-28.
Treatment repeats every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 6, 12, and 36 months.
- Conditions
- Adenomatous Polyp
- Being tested
- Aspirin, Eflornithine, Laboratory Biomarker Analysis, Placebo, Telephone-Based Intervention
- Medical subject headings
- Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Acetylsalicylic Acid, ASA, Aspergum, Ecotrin
Given PO
EflornithineDrug
Also called Alpha-Difluoromethylornithine, DFMO, difluoromethylornithine, Difluromethylornithine
Given PO
Laboratory Biomarker AnalysisOther
Correlative study
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given PO
Telephone-Based InterventionOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (acetylsalicylic acid and eflornithine) | Experimental | Patients receive acetylsalicylic acid PO once daily and eflornithine PO twice daily on days 1-28. Receives: Drug: Aspirin; Drug: Eflornithine; Other: Laboratory Biomarker Analysis; Other: Telephone-Based Intervention |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO three times daily on days 1-28. Receives: Other: Laboratory Biomarker Analysis; Other: Placebo; Other: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Recurrence Rate for the Treatment Arm Relative to Placebo
The primary endpoint is the proportion of participants with an adenoma recurrence at the 1-year follow-up colonoscopy exam. All eligible, randomized participants who have signed a consent form and received at least one follow-up endoscopy exam will be considered evaluable for the primary endpoint. This adenoma recurrence rate for DFMO + aspirin will be compared to double placebo to see if there is improvement in the adenoma recurrence rate in this patient population. A 1-sided Chi-square test was used to determine if there was a significant difference between treatment arms.
Measured: At 1 year
Secondary outcomes (4)
ACF Characteristics vs Adenoma Recurrence Rate
A potential surrogate endpoint biomarker is the aberrant crypt focus (ACF). ACF are the earliest lesions that can be detected in colorectal mucosa and are believed to be precursors of adenomas and cancers. At the 1-year time point, the presence of adenoma recurrence and the number of ACF sites was recorded for each patient. The percent change in ACF number was calculated as the number of ACF present at the 1-year post-intervention exam minus the baseline number of ACF, divided by the number of ACF present at baseline. A negative score represents a loss in the number of sites and a positive number indicates an increase in the number of ACF sites. Therefore, the possible range in percent change cannot be lower than -100% and has no upper bound. A Wilcoxon Rank-sum test was used to assess the relationship between ACF percent change and adenoma recurrence rate. This analysis was only conducted in those participants who had at least 5 rectal ACF at baseline.
Measured: At baseline and 1 year
Characterization of ACF
A potential surrogate endpoint biomarker is the aberrant crypt focus (ACF). ACF are the earliest lesions that can be detected in colorectal mucosa and are believed to be precursors of adenomas and cancers. The number and total size of ACF sites may serve as risk markers for adenoma/carcinoma development. The median number of ACF sites per patient were collected prior to treatment.
Measured: Baseline
Comparison of the Percent Change in ACF Number Across the 2 Treatment Arms
The number of ACF sites per patient was collected at baseline and at 1-year time points. The percent change in ACF number was calculated as the number of ACF present at the 12-month post-intervention exam minus the baseline number of ACF, divided by the number of ACF present at baseline. A negative score represents a loss in the number of sites from baseline to year 1 post-treatment. A positive number indicates an increase in the number of ACF sites. Therefore, the possible range in percent change cannot be lower than -100% and has no upper bound. The percent change in ACF number between arms was compared using a t-test.
Measured: At baseline and 12 months
Safety, Tolerability, and Adverse Events of Study Treatment
The National Cancer Institute (NCI) Common Terminology Criteria (CTC) Version 3.0 was used to grade all adverse events. The number of patients reporting a grade 3 or higher event are tabulated here. A grade 3 event is one categorized as being severe or medically significant but not immediately life-threatening. A grade 4 is considered life-threatening, and a grade 5 is death related to the event. A complete list of all adverse events is given in the Adverse Events section.
Measured: Up to 48 months from beginning treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study start20 Aug 2009
- Primary completion7 Oct 2016
- Study completion13 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenomatous PolypStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Frank A Sinicrope, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983580
- Sponsor's protocol ID
- NCI-2009-01192
- Other IDs
- NCI-2009-01192, 09-001758, MC054A, R01CA113681, P30CA015083
- Status last verified
- Aug 2019
- First submitted
- 23 Sep 2009
- Last updated
- 4 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Aspirin and Difluoromethylornithine (DFMO) in Patients at High Risk of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00983580
- Acronym / sponsor ID
- NCI-2009-01192
- Conditions
- Adenomatous Polyp
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 20 Aug 2009 (actual)
- Primary completion
- 7 Oct 2016 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 24 Sep 2009 (estimated)
- Results
- Posted 30 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well giving acetylsalicylic acid together with eflornithine works in treating patients at high risk for colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acetylsalicylic acid and eflornithine may prevent colorectal cancer.
Detailed description
PRIMARY OBJECTIVES:
- The proportion of subjects with an adenoma recurrence at the 1-year follow-up colonoscopy exam. This adenoma recurrence rate for difluoromethylornithine (DFMO) (eflornithine) + aspirin will be compared to double placebo to see if there is improvement in the adenoma recurrence rate in this patient population.
SECONDARY OBJECTIVES:
- To determine the relative tolerability and safety of the treatment regimens administered for 12 months.
II. To determine the effect of the study drugs (aspirin [acetylsalicylic acid] + DFMO) and placebo with respect to proliferation (Ki67 labeling index), apoptosis (caspase-3 expression assay), and drug effect markers (COX-1, -2, polyamines, PGE2) from adenomas, aberrant crypt focus (ACF) and normal-appearing mucosa using pre- and 12-month post-intervention tissue biopsy samples.
III. To estimate the percentage change in rectal ACF number, as determined by magnifying colonoscopy in subjects treated for 12 months with placebo or study drugs (aspirin +DFMO) by comparing % change in drug versus placebo arms.
IV. To characterize ACF based on three criteria (ACF size [crypt number < 50 or >= 50], crypt morphology characteristics, and histology) of ACF and to correlate such characteristics with the intervention (vs placebo). Also, to evaluate the natural history of ACF over 1-year on placebo.
- To correlate the 12-month measurements of ACF size (# crypts/ACF), number, morphology, and histopathology with the adenoma recurrence data at 12 and 36 months; correlate the 12-month % (and actual) change in ACF size and number with the 12- and 36-month adenoma recurrence rate; and correlate the adenoma recurrence data at 1 year with the adenoma recurrence data at 3 years.
TERTIARY OBJECTIVES:
- To explore the effects of the study agents on a focused panel of tissue biomarkers in pre- and post-intervention biopsy samples from recurrent adenomas, rectal ACF, and adjacent normal-appearing mucosa among subjects enrolled in the phase II clinical trial.
II. To determine if cleaved capase-3 expression can improve the detection of apoptotic cells by recognizing cellular commitment to apoptosis prior to late nuclear morphologic features and correlate with apoptotic regulatory proteins, histology, and treatment response.
III. To determine the effects of aspirin on its biochemical targets COX-1, -2, and prostaglandin E2, and polyamine levels in subjects receiving DFMO.
IV. To examine COX-2-dependent genes (i.e., Bcl-2 and DR5) in adenomas and ACF that have been shown to regulate the intrinsic mitochondrial and extrinsic death receptor-mediated apoptotic pathways in vitro and in vivo.
- To perform expression profiling of adenomas or ACF and to relate such date to ACF histology, size/morphology, modulation by chemopreventive agents, and subsequent adenoma recurrence rates.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive acetylsalicylic acid orally (PO) once daily and eflornithine PO twice daily on days 1-28.
ARM II: Patients receive placebo PO three times daily on days 1-28.
Treatment repeats every 28 days for 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 6, 12, and 36 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (acetylsalicylic acid and eflornithine) | Experimental | Drug: Aspirin, Drug: Eflornithine, Other: Laboratory Biomarker Analysis, Other: Telephone-Based InterventionPatients receive acetylsalicylic acid PO once daily and eflornithine PO twice daily on days 1-28. |
| Arm II (placebo) | Placebo comparator | Other: Laboratory Biomarker Analysis, Other: Placebo, Other: Telephone-Based InterventionPatients receive placebo PO three times daily on days 1-28. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Current or prior advanced adenomas
- Advanced adenomas are defined as subject with polyps >= 1 cm, tubulovillous adenomas (25-75 percent villous features), villous adenomas (> 75 percent villous), or high-grade dysplasia
- Prior colon cancer (>= 3 years out from invasive cancer)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Ability to under and the willingness to sign a written informed consent document
Key exclusion criteria (24 listed)
- Any history of current or prior rectal cancer
- Known diagnosis of colon heritable cancer syndrome (familial adenomatous polyposis [FAP], hereditary nonpolyposis colorectal cancer [HNPCC]) or inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- Inability to swallow pills
- Bleeding diathesis
- New diagnosis of carcinoma
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 |
|---|---|---|
| AspirinAlso: Acetylsalicylic Acid, ASA, Aspergum, EcotrinGiven PO | Drug | Arm I (acetylsalicylic acid and eflornithine) |
| EflornithineAlso: Alpha-Difluoromethylornithine, DFMO, difluoromethylornithine, DifluromethylornithineGiven PO | Drug | Arm I (acetylsalicylic acid and eflornithine) |
| Laboratory Biomarker AnalysisCorrelative study | Other | Arm I (acetylsalicylic acid and eflornithine), Arm II (placebo) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven PO | Other | Arm II (placebo) |
| Telephone-Based InterventionAncillary studies | Other | Arm I (acetylsalicylic acid and eflornithine), Arm II (placebo) |
Primary outcome
Adenoma Recurrence Rate for the Treatment Arm Relative to Placebo
Time frame: At 1 year
The primary endpoint is the proportion of participants with an adenoma recurrence at the 1-year follow-up colonoscopy exam. All eligible, randomized participants who have signed a consent form and received at least one follow-up endoscopy exam will be considered evaluable for the primary endpoint. This adenoma recurrence rate for DFMO + aspirin will be compared to double placebo to see if there is improvement in the adenoma recurrence rate in this patient population. A 1-sided Chi-square test was used to determine if there was a significant difference between treatment arms.
4 secondary outcomes
ACF Characteristics vs Adenoma Recurrence Rate
Time frame: At baseline and 1 year
Characterization of ACF
Time frame: Baseline
Comparison of the Percent Change in ACF Number Across the 2 Treatment Arms
Time frame: At baseline and 12 months
Safety, Tolerability, and Adverse Events of Study Treatment
Time frame: Up to 48 months from beginning treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Frank A Sinicrope principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin, Eflornithine and Laboratory Biomarker Analysis in people with Adenomatous Polyp, run by National Cancer Institute (NCI) at 3 sites 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 16 inclusion and 24 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: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 30 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adenoma Recurrence Rate for the Treatment Arm Relative to Placebo (time frame: At 1 year). 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 4 Sep 2019.