Celecoxib in Treating Patients With Early-Stage Rectal Cancer
Information source: Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Cancer
Intervention: celecoxib (Drug); gene expression analysis (Genetic); protein expression analysis (Genetic); immunohistochemistry staining method (Other); laboratory biomarker analysis (Other); mass spectrometry (Other); biopsy (Procedure); neoadjuvant therapy (Procedure); therapeutic conventional surgery (Procedure)
Phase: N/A
Status: Terminated
Sponsored by: Vanderbilt-Ingram Cancer Center Official(s) and/or principal investigator(s): A. Bapsi Chakravarthy, MD, Principal Investigator, Affiliation: Vanderbilt-Ingram Cancer Center
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.
Clinical Details
Official title: Pilot COX-2 Activity in Early Stage Rectal Cancer -Short Term Administration of Celecoxib (SPORE)
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Event rate of over-expression of cyclooxygenase-2Percent change of eicosanoid level Percent change of VEGF and prostaglandin-M levels Change of gene and protein expression pattern from pre- to post-treatment levels
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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:
Not noted
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
Locations and Contacts
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232, United States
Veterans Administration, Nashville, Tennessee 37212, United States
Additional Information
Starting date: July 2002
Last updated: March 2, 2013
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