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Trial record 86 of 543 for:    Celecoxib

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. Identifier: NCT00608595
Recruitment Status : Terminated (low accrual)
First Posted : February 6, 2008
Last Update Posted : March 5, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center

Brief 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.

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

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Therapeutic Intervention/Celecoxib
Drug: celecoxib
Will be administered orally 400 mg po BID starting 5 days prior to planned surgical resection.
Other Name: Celebrex

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
Not specified

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

Primary Outcome Measures :
  1. Event rate of over-expression of cyclooxygenase-2 [ Time Frame: Pre and post 7 days administration of study drug ]
  2. Percent change of eicosanoid level [ Time Frame: Pre and post celecoxib treatment ratio of eicosanoid production ]
  3. Percent change of VEGF and prostaglandin-M levels [ Time Frame: Pre and post celecoxib treatment VEGF and PGE-M levels ]
  4. Change of gene and protein expression pattern from pre- to post-treatment levels [ Time Frame: Pre and post celecoxib treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of primary adenocarcinoma of the rectum (to be histologically confirmed upon study entry)

    • Tumor must be at or below the peritoneal reflection
    • The distal border of the tumor is within 12 cm of the anal verge on proctoscopic examination
  • Clinically resectable disease


  • Karnofsky performance status 60-100%
  • WBC ≥ 4,000/mm³
  • Platelet count ≥ 150,000/mm³
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other serious medical illness (other than rectal cancer) that would preclude study therapy
  • No psychiatric condition that would preclude informed consent
  • No history of allergy to celecoxib or any other NSAIDs, including acetylsalicylic acid (i.e., aspirin), ibuprofen, or indomethacin
  • No history of allergy to sulfonamides

Exclusion criteria:

Not noted


  • At least 7 days since prior and no concurrent NSAIDs or other cyclooxygenase-2 inhibitors
  • No concurrent warfarin, except low-dose warfarin (i.e., 1 mg/day) administered for prophylaxis

Information from the National Library of Medicine

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 identifier (NCT number): NCT00608595

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United States, Tennessee
Veterans Administration
Nashville, Tennessee, United States, 37212
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center

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Responsible Party: A Bapsi Chakravarthy, MD, Professor of Medicine, Medical Oncologist, Vanderbilt-Ingram Cancer Center Identifier: NCT00608595     History of Changes
Other Study ID Numbers: VICC GI 0174
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013
Keywords provided by A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center:
adenocarcinoma of the rectum
recurrent rectal cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action