NCT00685568

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 colorectal-cancer

Timeline
Completed

Started Nov 2002

Geographic Reach
1 country

4 active sites

Status
completed

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

November 21, 2002

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

3.4 years

First QC Date

May 23, 2008

Last Update Submit

November 5, 2018

Conditions

Colorectal CancerPrecancerous Condition

Keywords

colon cancerrectal cancerfamilial adenomatous polyposis

Outcome Measures

Primary Outcomes (1)

  • Toxicity

    3 months

Secondary Outcomes (9)

  • Aberrant crypt foci (ACF) and adenoma burden in the entire colorectum

    3 months

  • Elimination of the learning curve in a phase II/III trial

    3 months

  • Comparison of sedation strategies based on local standards

    3 months

  • Validation of technique for scoring ACFs

    3 months

  • Short-term (3 month) impact of celecoxib on ACF count

    3 months

  • +4 more secondary outcomes

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral celecoxib twice daily for 3 months in the absence of disease progression or unacceptable toxicity.

Drug: celecoxib

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo twice daily for 3 months in the absence of disease progression or unacceptable toxicity.

Other: placebo

Interventions

celecoxibDRUG

Orally, twice daily for 3 months; 50 mg tablets. Celecoxib escalating doses starting at 4 mg/kg/day.

Arm I
placeboOTHER

Orally, twice daily for 3 months

Arm II

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

University of Texas Medical School at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 20234350RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsPrecancerous ConditionsColonic NeoplasmsRectal NeoplasmsAdenomatous Polyposis Coli

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAdenomatous PolypsAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplastic Syndromes, HereditaryIntestinal PolyposisGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Patrick M. Lynch, MD, JD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2008

First Posted

May 28, 2008

Study Start

November 21, 2002

Primary Completion

April 21, 2006

Study Completion

April 21, 2006

Last Updated

November 7, 2018

Record last verified: 2018-11

Locations

US(4)