Celecoxib, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

July 31, 2002

Primary Completion Date

November 30, 2004

Study Completion Date

March 31, 2008

Conditions
Colorectal Cancer
Interventions
DRUG

celecoxib

twice daily beginning 5 days prior to radiotherapy and continuing until completion of radiotherapy

DRUG

fluorouracil

Patients receive concurrent fluorouracil IV continuously for 5 weeks.

PROCEDURE

conventional surgery

4-10 weeks after completion of chemoradiotherapy

RADIATION

radiation therapy

Patients undergo radiotherapy 5 days a week for 5 weeks

PROCEDURE

tumor biopsy

at baseline and then at the time of surgical resection

OTHER

laboratory biomarker analysis

blood and urine collected at baseline, 5 days after initiation of celecoxib, 7 days after initiation of celecoxib in combination with fluorouracil and radiotherapy, and at the time of surgical resection. specimens are evaluated for COX-2 expression, eicosanoid production, and gene and protein expression using immunohistochemistry, microarray, and mass spectrometry.

Trial Locations (2)

37212

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville

37232-5671

Vanderbilt-Ingram Cancer Center, Nashville

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Vanderbilt-Ingram Cancer Center

OTHER

NCT00336960 - Celecoxib, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery | Biotech Hunter | Biotech Hunter