NCT00608595

Celecoxib in Treating Patients With Early-Stage Rectal Cancer

Pilot COX-2 Activity in Early Stage Rectal Cancer -Short Term Administration of Celecoxib (SPORE)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	celecoxib	Will be administered orally 400 mg po BID starting 5 days prior to planned surgical resection.
GENETIC	gene expression analysis	not noted
GENETIC	protein expression analysis	Not noted
OTHER	immunohistochemistry staining method	not noted
OTHER	laboratory biomarker analysis	not noted
OTHER	mass spectrometry
PROCEDURE	biopsy	At the time of preoperative evaluation by surgeon as well as one week after administration of Celecoxib.
PROCEDURE	neoadjuvant therapy	not noted
PROCEDURE	therapeutic conventional surgery	not noted

Timeline

• Start date: 2002-07-01
• Primary completion: 2004-05-01
• Completion: 2008-04-01
• First posted: 2008-02-06
• Last updated: 2013-03-05

Locations

2 sites across 1 country: United States