Colorectal CancerPhase 1NCT00685568
Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis
A Phase 1 study testing celecoxib in people with Colorectal Cancer and Precancerous Condition, run by M.D. Anderson Cancer Center at 4 sites in United States.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of celecoxib may keep polyps and colorectal cancer from forming in patients with familial adenomatous polyposis. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Colorectal Cancer, Precancerous Condition
- What is being tested?
- celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Nov 2002to 21 Apr 2006
- Phase
- Phase 1
- 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 10 to 14 years
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS:
- Diagnosis of familial adenomatous polyposis (FAP) based on genetic predisposition testing
- Genotype-positive FAP (pathologic Adenomatous polyposis coli (APC) mutation)
- No attenuated FAP genotype, defined by any of the following:
- Mutation at the 5' end of APC and exon 4
- Exon 9-associated phenotypes
- 3' region mutations
- Has an intact colon
- No requirement for colectomy
- Parent(s) do not desire colectomy (regardless of adenoma burden)
- Colorectal adenoma burden as assessed by baseline colonoscopy
- No diagnosis of severe dysplasia or greater
- No more than 10 adenomas ≥ 1 cm
- No more than 100 adenomas of any size
- No evidence of anemia (hematocrit < 33%)
- No new diagnosis of carcinoma
PATIENT CHARACTERISTICS:
- White Blood Count (WBC) > 3,000/μL
- Platelet count > 100,000/μL
- Hemoglobin > 10.0 g/dL
- Aspartate aminotransferase/alanine aminotransferase (AST/ALT) < 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase < 1.5 times ULN
- Total bilirubin < 1.5 times ULN
- Creatinine < 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of hypersensitivity to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates
- No history of peptic ulcer disease
- No significant medical or psychiatric problem that, in the opinion of the principal investigator, would make the patient a poor candidate for the study
- No other unacceptable clinical risk (e.g., previously unknown bleeding diatheses)
- No invasive carcinoma within the past 5 years
PRIOR CONCURRENT THERAPY:
- More than 3 months since prior investigational agent
- More than 6 months since prior chemotherapy
- No prior radiotherapy to the pelvis
- At least 3 months since prior NSAIDs (at any dose) at a frequency of ≥ 3 times/week
- At least 1 month since prior NSAIDs (at any dose) at a frequency of < 3 times/week
- At least 1 month since prior nasal steroids
- Concurrent Nonsteroidal Antiinflammatory Drugs (NSAIDs) allowed provided they are administered ≤ 5 times per month
- Concurrent orally inhaled steroids allowed provided they are administered for ≤ 4 weeks over a 6-month period
- Concurrent oral or intravenous (IV) corticosteroids allowed provided they are administered for ≤ 2 consecutive weeks over a 6-month period
- Concurrent proton pump inhibitors to treat gastric reflux allowed
- No concurrent nasal steroids except mometasone (Nasonex)
- No concurrent fluconazole, lithium, or adrenocorticosteroids
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
Texas Children's Hospital
Houston, Texas, 77030
University of Texas Medical School at Houston
Houston, Texas, 77030
About this study
Official title: Phase I Pilot Toxicity/Methods Validation Study of Celecoxib in Genotype-Positive Children With Familial Adenomatous Polyposis
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of celecoxib may keep polyps and colorectal cancer from forming in patients with familial adenomatous polyposis.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of celecoxib in treating young patients with a genetic predisposition for familial adenomatous polyposis.
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety and toxicity of celecoxib in pediatric patients with genotype-positive familial adenomatous polyposis.
Secondary
- Determine the aberrant crypt foci (ACF) and adenoma burden in the entire colorectum of these patients.
- Eliminate the learning curve in a phase II/III trial (reproducibility of endoscopic techniques, tolerability of procedure).
- Compare sedation strategies based on local standards (monitored anesthesia care vs conscious sedation).
- Validate the ACF scoring technique.
- Establish the short-term (3 month) impact of celecoxib on ACF count in order to determine appropriateness of ACF as a pathologic endpoint in a phase II/III trial.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral celecoxib twice daily for 3 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral placebo twice daily for 3 months in the absence of disease progression or unacceptable toxicity.
Patients undergo colonoscopy at baseline and at 3 months. Patients also complete psychosocial questionnaires at baseline.
Blood samples are collected at baseline to assess the influence of polymorphisms (CYP2C9, uridine diphosphate (UDP)-glucuronosyl transferase, A6, glutathione S-transferase [GST] M1, and Glutathione S-transferase (GST) theta 1 (GSTT1)) on age of onset of phenotype or number of colorectal polyps. Plasma drug trough levels are assessed at baseline, 1 month, and 3 months.
After completion of study treatment, patients are followed periodically for up to 2 months.
- Conditions
- Colorectal Cancer, Precancerous Condition
- Being tested
- celecoxib, placebo
- Keywords
- colon cancer, rectal cancer, familial adenomatous polyposis
- Medical subject headings
- Colorectal Neoplasms, Precancerous Conditions, Colonic Neoplasms, Rectal Neoplasms, Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
Orally, twice daily for 3 months; 50 mg tablets. Celecoxib escalating doses starting at 4 mg/kg/day.
placeboOther
Orally, twice daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral celecoxib twice daily for 3 months in the absence of disease progression or unacceptable toxicity. Receives: Drug: celecoxib |
| Arm II | Placebo comparator | Patients receive oral placebo twice daily for 3 months in the absence of disease progression or unacceptable toxicity. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Measured: 3 months
Secondary outcomes (9)
Aberrant crypt foci (ACF) and adenoma burden in the entire colorectum
Measured: 3 months
Elimination of the learning curve in a phase II/III trial
Measured: 3 months
Comparison of sedation strategies based on local standards
Measured: 3 months
Validation of technique for scoring ACFs
Measured: 3 months
Short-term (3 month) impact of celecoxib on ACF count
Measured: 3 months
Adherence
Measured: 3 months
Influence of polymorphisms on age of onset of phenotype or on the number of colorectal polyps
Measured: 3 months
Feasibility of psychosocial questionnaires
Measured: 3 months
Pharmacokinetics (plasma drug trough concentrations)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study start21 Nov 2002
- Primary completion21 Apr 2006
- Study completion21 Apr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 22 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
- Patrick M. Lynch, MD, JD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685568
- Sponsor's protocol ID
- ID02-090
- Other IDs
- MDA-ID-02090, CDR0000596468
- Status last verified
- Nov 2018
- First submitted
- 23 May 2008
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lynch PM, Ayers GD, Hawk E, Richmond E, Eagle C, Woloj M, Church J, Hasson H, Patterson S, Half E, Burke CA. The safety and efficacy of celecoxib in children with familial adenomatous polyposis. Am J Gastroenterol. 2010 Jun;105(6):1437-43. doi: 10.1038/ajg.2009.758. Epub 2010 Mar 16.
PubMed 20234350
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Pilot Toxicity/Methods Validation Study of Celecoxib in Genotype-Positive Children With Familial Adenomatous Polyposis
- ClinicalTrials.gov ID
- NCT00685568
- Acronym / sponsor ID
- ID02-090
- Conditions
- Colorectal Cancer, Precancerous Condition
- Keywords
- colon cancer, rectal cancer, familial adenomatous polyposis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Nov 2002 (actual)
- Primary completion
- 21 Apr 2006 (actual)
- Study completion
- 21 Apr 2006 (actual)
- First posted
- 28 May 2008 (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 is the use of certain drugs to keep cancer from forming. The use of celecoxib may keep polyps and colorectal cancer from forming in patients with familial adenomatous polyposis.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of celecoxib in treating young patients with a genetic predisposition for familial adenomatous polyposis.
Detailed description
OBJECTIVES:
Primary
- Determine the safety and toxicity of celecoxib in pediatric patients with genotype-positive familial adenomatous polyposis.
Secondary
- Determine the aberrant crypt foci (ACF) and adenoma burden in the entire colorectum of these patients.
- Eliminate the learning curve in a phase II/III trial (reproducibility of endoscopic techniques, tolerability of procedure).
- Compare sedation strategies based on local standards (monitored anesthesia care vs conscious sedation).
- Validate the ACF scoring technique.
- Establish the short-term (3 month) impact of celecoxib on ACF count in order to determine appropriateness of ACF as a pathologic endpoint in a phase II/III trial.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral celecoxib twice daily for 3 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive oral placebo twice daily for 3 months in the absence of disease progression or unacceptable toxicity.
Patients undergo colonoscopy at baseline and at 3 months. Patients also complete psychosocial questionnaires at baseline.
Blood samples are collected at baseline to assess the influence of polymorphisms (CYP2C9, uridine diphosphate (UDP)-glucuronosyl transferase, A6, glutathione S-transferase [GST] M1, and Glutathione S-transferase (GST) theta 1 (GSTT1)) on age of onset of phenotype or number of colorectal polyps. Plasma drug trough levels are assessed at baseline, 1 month, and 3 months.
After completion of study treatment, patients are followed periodically for up to 2 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: celecoxibPatients receive oral celecoxib twice daily for 3 months in the absence of disease progression or unacceptable toxicity. |
| Arm II | Placebo comparator | Other: placeboPatients receive oral placebo twice daily for 3 months in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| celecoxibOrally, twice daily for 3 months; 50 mg tablets. Celecoxib escalating doses starting at 4 mg/kg/day. | Drug | Arm I |
| placeboOrally, twice daily for 3 months | Other | Arm II |
Primary outcome
Toxicity
Time frame: 3 months
9 secondary outcomes
Aberrant crypt foci (ACF) and adenoma burden in the entire colorectum
Time frame: 3 months
Elimination of the learning curve in a phase II/III trial
Time frame: 3 months
Comparison of sedation strategies based on local standards
Time frame: 3 months
Validation of technique for scoring ACFs
Time frame: 3 months
Short-term (3 month) impact of celecoxib on ACF count
Time frame: 3 months
Adherence
Time frame: 3 months
Influence of polymorphisms on age of onset of phenotype or on the number of colorectal polyps
Time frame: 3 months
Feasibility of psychosocial questionnaires
Time frame: 3 months
Pharmacokinetics (plasma drug trough concentrations)
Time frame: 3 months
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 7 Nov 2018.
- Results publication: PubMed 20234350Lynch PM, Ayers GD, Hawk E, Richmond E, Eagle C, Woloj M, Church J, Hasson H, Patterson S, Half E, Burke CA. The safety and efficacy of celecoxib in children with familial adenomatous polyposis. Am J Gastroenterol. 2010 Jun;105(6):1437-43. doi: 10.1038/ajg.2009.758. Epub 2010 Mar 16.
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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.
Patrick M. Lynch, MD, JD study chair
M.D. Anderson Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing celecoxib in people with Colorectal Cancer and Precancerous Condition, run by M.D. Anderson Cancer Center at 4 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 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Toxicity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00685568, which also lists 1 linked publication.
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 7 Nov 2018.