NCT00033371View on ClinicalTrials.gov

Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis

PHASE2CompletedINTERVENTIONAL
Enrollment

205

Participants

Timeline

Start Date

December 13, 2001

Primary Completion Date

February 24, 2009

Study Completion Date

March 24, 2009

Conditions
Colorectal CancerFamilial Adenomatous Polyposis
Interventions
DRUG

Celecoxib

Given 400 mg PO twice a day

OTHER

Placebo

Given PO to match DFMO

DRUG

eflornithine

Given PO at 0.5 gm/m\^2/day rounded down to the nearest 250 mg dose (BSA of \< 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of \> 2.6 = 1,250 mg/day).

OTHER

Laboratory biomarker analysis

Correlative studies

OTHER

Questionnaire administration

Ancillary studies

Trial Locations (1)

77030

M D Anderson Cancer Center, Houston

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00033371 - Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis | Biotech Hunter | Biotech Hunter