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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00608595 |
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 | Intervention |
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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 |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pilot COX-2 Activity in Early Stage Rectal Cancer -Short Term Administration of Celecoxib (SPORE) |
Estimated Enrollment: | 120 |
Study Start Date: | July 2002 |
Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Clinical diagnosis of primary adenocarcinoma of the rectum (to be histologically confirmed upon study entry)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000581358, VU-VICC-GI-0174 |
Study First Received: | January 30, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00608595 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the rectum recurrent rectal cancer stage I rectal cancer stage II rectal cancer stage III rectal cancer |
Anti-Inflammatory Agents Celecoxib Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Cyclooxygenase Inhibitors Colonic Diseases Rectal Neoplasm Intestinal Diseases Rectal Diseases Recurrence |
Intestinal Neoplasms Digestive System Diseases Rectal Cancer Analgesics, Non-Narcotic Gastrointestinal Neoplasms Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Adenocarcinoma Colorectal Neoplasms |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Physiological Effects of Drugs Rectal Diseases Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Celecoxib Digestive System Neoplasms |
Cyclooxygenase Inhibitors Enzyme Inhibitors Intestinal Diseases Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Analgesics, Non-Narcotic Gastrointestinal Neoplasms Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Colorectal Neoplasms |