NCT00043043

Brief 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 neoplasia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 2003

Typical duration for phase_2 colorectal-cancer

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

August 5, 2002

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2003

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 19, 2013

Status Verified

November 1, 2004

First QC Date

August 5, 2002

Last Update Submit

June 18, 2013

Conditions

Colorectal Cancer

Keywords

colorectal cancer

Interventions

celecoxibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

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

Sponsors & Collaborators

Study Sites (2)

National Naval Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ernest Hawk

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

August 5, 2002

First Posted

January 27, 2003

Study Start

May 1, 2003

Study Completion

October 1, 2007

Last Updated

June 19, 2013

Record last verified: 2004-11

Locations

US(2)