Loading clinical trials...
Loading clinical trials...
Pilot COX-2 Activity in Early Stage Rectal Cancer -Short Term Administration of Celecoxib (SPORE)
RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how rectal cancer will respond to treatment with celecoxib. PURPOSE: This clinical trial is studying how well celecoxib works in treating patients with early-stage rectal cancer.
OBJECTIVES: * Determine cyclooxygenase-2 (COX-2) over-expression in tumor specimens from patients with early-stage rectal cancer. * Determine whether administration of a COX-2 inhibitor, celecoxib, results in changes in tumor (COX-2 overexpressing) levels of eicosanoids but not in levels in the surrounding normal tissue that is expected not to express COX-2. * Determine whether surrogate markers of eicosanoid metabolism (i.e., serum VEGF levels, tumor prostaglandin E\_2 \[PGE\_2\], and the major urinary metabolite of PGE\_2 \[PGE-M\]) in biological specimens from these patients correlate with changes noted in tumor tissue. * Determine if there is a greater change in protein and gene expression from pretreatment biopsy levels in patient tumor specimens (COX-2 overexpressing) vs specimens of surrounding normal tissue (expected not to be COX-2 overexpressing). OUTLINE: Patients receive oral celecoxib twice daily on days 1-5. Patients then undergo planned local excision or definitive radical resection on day 6. Tumor tissue and normal tissue (at least 5 cm away from the tumor) samples are collected pretreatment. Post-treatment tissue samples are collected along with the surgery. Serum and urine samples are obtained at baseline and after administration of celecoxib. Tumor and normal tissue specimens are analyzed by assays measuring markers of cyclooxygenase-2 (COX-2) activity (i.e., COX-2 mRNA and protein, tumor prostaglandin E\_2 \[PGE\_2\], and VEGF). Tissue samples are also assessed by cDNA microarray and imaging mass spectrometry to determine overall changes in gene and protein expression from pretreatment levels. Surrogate markers of COX-2 activity in serum (i.e., VEGF) and urine (i.e., urinary metabolite of PGE\_2 \[PGE-M\]) are also assessed and compared with changes noted in tumor tissue. COX-2 protein levels are determined by immunohistochemistry in patients with limited pretreatment tumor tissue specimens.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Veterans Administration
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Start Date
July 1, 2002
Primary Completion Date
May 1, 2004
Completion Date
April 1, 2008
Last Updated
March 5, 2013
10
ACTUAL participants
celecoxib
DRUG
gene expression analysis
GENETIC
protein expression analysis
GENETIC
immunohistochemistry staining method
OTHER
laboratory biomarker analysis
OTHER
mass spectrometry
OTHER
biopsy
PROCEDURE
neoadjuvant therapy
PROCEDURE
therapeutic conventional surgery
PROCEDURE
Lead Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
NCT06696768
NCT04704661
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions