Celecoxib in Treating Patients With Early-Stage Rectal Cancer
NCT ID: NCT00608595
Last Updated: 2013-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2002-07-31
2008-04-30
Brief Summary
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PURPOSE: This clinical trial is studying how well celecoxib works in treating patients with early-stage rectal cancer.
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Detailed Description
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* 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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Therapeutic Intervention/Celecoxib
Celecoxib
celecoxib
Will be administered orally 400 mg po BID starting 5 days prior to planned surgical resection.
gene expression analysis
not noted
protein expression analysis
Not noted
immunohistochemistry staining method
not noted
laboratory biomarker analysis
not noted
mass spectrometry
biopsy
At the time of preoperative evaluation by surgeon as well as one week after administration of Celecoxib.
neoadjuvant therapy
not noted
therapeutic conventional surgery
not noted
Interventions
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celecoxib
Will be administered orally 400 mg po BID starting 5 days prior to planned surgical resection.
gene expression analysis
not noted
protein expression analysis
Not noted
immunohistochemistry staining method
not noted
laboratory biomarker analysis
not noted
mass spectrometry
biopsy
At the time of preoperative evaluation by surgeon as well as one week after administration of Celecoxib.
neoadjuvant therapy
not noted
therapeutic conventional surgery
not noted
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
PATIENT CHARACTERISTICS:
* 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
PRIOR CONCURRENT THERAPY:
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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A Bapsi Chakravarthy, MD
Professor of Medicine, Medical Oncologist
Principal Investigators
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A. Bapsi Chakravarthy, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Veterans Administration
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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VU-VICC-GI-0174
Identifier Type: -
Identifier Source: secondary_id
VICC GI 0174
Identifier Type: -
Identifier Source: org_study_id
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