Status:
COMPLETED
Celecoxib, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil...
Detailed Description
OBJECTIVES: * Determine cyclo-oxygenase-2 (COX-2) overexpression in patients with resectable stage II or III rectal cancer treated with neoadjuvant celecoxib, fluorouracil, and radiotherapy. * Determ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary adenocarcinoma of the rectum
- Stage II or III disease
- Distal border of tumor must be at or below the peritoneal reflection
- Distal border of the tumor must be within 12 cm of the anal verge by proctoscopic exam
- Tumor must be clinically resectable
- Transmural penetration beyond muscularis propria by transrectal ultrasound
- No high-grade obstruction
- No evidence of metastatic 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 or psychiatric condition that would preclude study treatment
- No history of allergy to celecoxib or any other NSAIDs
- No history of allergy to sulfonamides
- No prior or concurrent malignancy except inactive noninvasive cervical carcinoma or skin cancer (excluding melanoma) or other cancer that has been disease free for ≥ 5 years
- PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the pelvis
- At least 7 days since prior and no other concurrent COX-2 inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs)
- No concurrent warfarin except low-dose warfarin (1 mg/day)
Exclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00336960
Start Date
July 1 2002
End Date
March 1 2008
Last Update
March 5 2013
Active Locations (2)
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1
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, United States, 37212
2
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-5671