Colorectal CancerPhase 2NCT00043043
Celecoxib in Preventing Cancer in Patients With Rectal Polyps or Colorectal Neoplasia
A Phase 2 study testing celecoxib in people with Colorectal Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.
Trial summary
RATIONALE: Celecoxib may be effective in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia. PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- celecoxib
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- May 2003to Oct 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Age 18 to 49 with one of the following colorectal abnormalities:
- At least one adenoma that is at least 1 cm
- At least 3 adenomas of any size with at least 5 rectal aberrant crypt foci (ACFs)
- Age 50 and over with one of the following colorectal abnormalities:
- At least one adenoma that is at least 5 mm and at least 5 rectal ACFs
- History of polyps (at least 1 adenoma) within the past 5 years
- No history of germline cancer syndrome
- No stage III or IV colorectal cancer (Dukes' C or D) diagnosed within the past 6 months
- No current colorectal cancer
- No inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
PATIENT CHARACTERISTICS:
Age
- See Disease Characteristics
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Hemoglobin greater than 11.5 g/dL
- WBC greater than 3,000/mm^3
- Platelet count greater than 125,000/mm^3
- No significant bleeding disorder
Hepatic
- AST and ALT no greater than 1.5 times upper limit of normal (ULN)
- Bilirubin no greater than 1.5 times ULN
- Alkaline phosphatase no greater than 1.5 times ULN
- No chronic or acute hepatic disorder
Renal
- Creatinine no greater than 1.5 times ULN
- No chronic or acute renal disorder
Cardiovascular
- No uncontrolled hypertension
- No unstable angina
- No congestive heart failure
Pulmonary
- No asthma
- No severe chronic obstructive pulmonary disease
Gastrointestinal
- No active gastrointestinal ulcers
- No history of peptic ulcer disease
Other
- No prior hypersensitivity reaction to NSAIDs, aspirin, or sulfa drugs
- No medical contraindication to NSAID use
- Not pregnant or nursing
- Negative pregnancy test
- Fertile female patients must use effective contraception
- No known allergic reaction to indigo carmine
- No other clinically significant medical condition or abnormal laboratory value that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Anticipated use of corticosteroids less than 2 weeks over 6 months
- Anticipated use of mometasone less than 4 weeks over 6 months
- No other concurrent inhaled steroids for 30 days before or during study participation
Radiotherapy
- No prior pelvic radiotherapy
Surgery
- Not specified
Other
- More than 30 days since prior investigational drugs
- No prior participation in this study
- No regular nonsteroidal anti-inflammatory drug (NSAID) or aspirin use (average of 3 or more doses per week for at least 3 months) except low-dose aspirin for cardiovascular disease prophylaxis
- No other concurrent investigational drugs
- No concurrent fluconazole or lithium
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Naval Medical Center
Bethesda, Maryland, 20889-5600
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
About this study
Official title: Rectal Abberant Crypt Foci And Other Intermediate Biomarkers For Sporadic Colorectal Neoplasia: Cross-Sectional Prevelance And Modulation By Celecoxib
RATIONALE: Celecoxib may be effective in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia.
PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia.
Read the detailed description
OBJECTIVES:
Primary
- Compare the effects of celecoxib vs placebo on the number of rectal aberrant crypt foci in patients with premalignant rectal polyps or prior sporadic colorectal neoplasia.
Secondary
- Compare the effects of these drugs on proliferation index, apoptotic index, and gene expression patterns in ascending and descending colon tissue from these patients before and after treatment.
- Assess gene expression patterns in normal mucosa from the ascending vs descending colon in patients referred for screening, surveillance, or diagnostic colonoscopy.
OUTLINE: This is a randomized, double-blind, placebo-controlled, chemoprevention study. Patients are stratified according to age (18 to 49 vs 50 and over) and number of rectal aberrant crypt foci (5-9 vs 10 or more).
All patients undergo a baseline biomarker assessment and full colonoscopy to resect all neoplasms, quantitate rectal aberrant crypt foci, and biopsy rectal mucosa.
Depending on the results of the biomarker assessments, patients are randomized to 1 of 2 treatment arms. Patients with no adenomas of 5 mm or greater receive no further treatment.
- Arm I: Patients receive oral celecoxib twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 6 months in the absence of unacceptable toxicity.
All patients undergo an endoscopic exam of the colorectum at completion of study.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for the baseline biomarker assessment and a total of 40 patients (20 per arm) will be accrued for the chemoprevention study within 1 year.
- Conditions
- Colorectal Cancer
- Being tested
- celecoxib
- Keywords
- colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 2003
- Study completionOct 2007
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 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
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Ernest Hawk, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043043
- Sponsor's protocol ID
- CDR0000069498
- Other IDs
- NCI-02-C-0194
- Status last verified
- Nov 2004
- First submitted
- 5 Aug 2002
- Last updated
- 19 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Abberant Crypt Foci And Other Intermediate Biomarkers For Sporadic Colorectal Neoplasia: Cross-Sectional Prevelance And Modulation By Celecoxib
- ClinicalTrials.gov ID
- NCT00043043
- Acronym / sponsor ID
- CDR0000069498
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2003
- Study completion
- Oct 2007 (actual)
- First posted
- 27 Jan 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: Celecoxib may be effective in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia.
PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia.
Detailed description
OBJECTIVES:
Primary
- Compare the effects of celecoxib vs placebo on the number of rectal aberrant crypt foci in patients with premalignant rectal polyps or prior sporadic colorectal neoplasia.
Secondary
- Compare the effects of these drugs on proliferation index, apoptotic index, and gene expression patterns in ascending and descending colon tissue from these patients before and after treatment.
- Assess gene expression patterns in normal mucosa from the ascending vs descending colon in patients referred for screening, surveillance, or diagnostic colonoscopy.
OUTLINE: This is a randomized, double-blind, placebo-controlled, chemoprevention study. Patients are stratified according to age (18 to 49 vs 50 and over) and number of rectal aberrant crypt foci (5-9 vs 10 or more).
All patients undergo a baseline biomarker assessment and full colonoscopy to resect all neoplasms, quantitate rectal aberrant crypt foci, and biopsy rectal mucosa.
Depending on the results of the biomarker assessments, patients are randomized to 1 of 2 treatment arms. Patients with no adenomas of 5 mm or greater receive no further treatment.
- Arm I: Patients receive oral celecoxib twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 6 months in the absence of unacceptable toxicity.
All patients undergo an endoscopic exam of the colorectum at completion of study.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for the baseline biomarker assessment and a total of 40 patients (20 per arm) will be accrued for the chemoprevention study within 1 year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| celecoxib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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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.
Ernest Hawk study chair
National Cancer Institute (NCI)
2 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 celecoxib in people with Colorectal Cancer, run by National Cancer Institute (NCI) at 2 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?
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 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 19 Jun 2013.