Status:
TERMINATED
Celecoxib in Treating Patients With Early-Stage Rectal Cancer
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 c...
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, r...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00608595
Start Date
July 1 2002
End Date
April 1 2008
Last Update
March 5 2013
Active Locations (2)
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1
Veterans Administration
Nashville, Tennessee, United States, 37212
2
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232