Celecoxib in Treating Patients With Early-Stage Rectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00608595|
Recruitment Status : Terminated (low accrual)
First Posted : February 6, 2008
Last Update Posted : March 5, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: celecoxib Genetic: gene expression analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: mass spectrometry Procedure: biopsy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot COX-2 Activity in Early Stage Rectal Cancer -Short Term Administration of Celecoxib (SPORE)|
|Study Start Date :||July 2002|
|Actual Primary Completion Date :||May 2004|
|Actual Study Completion Date :||April 2008|
Experimental: Therapeutic Intervention/Celecoxib
Will be administered orally 400 mg po BID starting 5 days prior to planned surgical resection.
Other Name: Celebrex
Genetic: gene expression analysis
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: mass spectrometry
At the time of preoperative evaluation by surgeon as well as one week after administration of Celecoxib.
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
- Event rate of over-expression of cyclooxygenase-2 [ Time Frame: Pre and post 7 days administration of study drug ]
- Percent change of eicosanoid level [ Time Frame: Pre and post celecoxib treatment ratio of eicosanoid production ]
- Percent change of VEGF and prostaglandin-M levels [ Time Frame: Pre and post celecoxib treatment VEGF and PGE-M levels ]
- Change of gene and protein expression pattern from pre- to post-treatment levels [ Time Frame: Pre and post celecoxib treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608595
|United States, Tennessee|
|Nashville, Tennessee, United States, 37212|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||A. Bapsi Chakravarthy, MD||Vanderbilt-Ingram Cancer Center|