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Phase III Randomized Chemoprevention Study of Celecoxib in Patients With Resected Stage I Adenocarcinoma of the Colon
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon Cancer
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase III
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Prevention
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Completed
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18 and over
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NCI
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NSABP-P-3 NCT00087256
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Objectives Primary - Compare celecoxib vs placebo, in terms of decreasing the incidence of adenomatous polyps of the colon and rectum, in patients with resected stage I adenocarcinoma of the colon.
Secondary - Compare disease-free survival of patients treated with these regimens.
- Compare the effect of these regimens on self-reported symptoms and health-related quality of life of these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the benefits of celecoxib in patients with primary tumors or polyps that express cyclo-oxygenase-2 (COX-2) with those that do not express COX-2.
- Determine the toxicity and safety of celecoxib in these patients.
Entry Criteria Disease Characteristics:
- Histologically confirmed adenocarcinoma of the colon
- Stage I disease
- Distal border of tumor ≥ 12 cm from the anal verge
- Tumor completely resected within the past 90 days
- Must have undergone a preoperative or postoperative colonoscopy to the cecum (or small bowel anastomosis) within the past 90 days
- All observed polyps must have been removed
- Patients with a history suggestive of hereditary non-polyposis colorectal cancer (HNPCC) must have a normal microsatellite instability status by immunohistochemistry or polymerase chain reaction
- Patients with family history of colon cancer who have not been diagnosed with HNPCC are eligible
- No prior familial adenomatous polyposis
- No prior invasive cancer or carcinoma in situ of the colon or rectum
- No clinical or radiologic evidence of metastatic disease
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy Radiotherapy Surgery - See Disease Characteristics
Other - No other concurrent investigational agents for colon cancer
- No concurrent chronic use of other cyclo-oxygenase-2 (COX-2) inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), or salicylates (e.g., aspirin)
- Chronic use is defined as use for more than an average of 3 days per month
- Concurrent NSAIDs allowed for up to 10 consecutive days for temporary relief due to inflammatory syndromes, injury, or postoperative pain
- Cardioprotective doses of aspirin (≤ 81 mg/day or 325 mg every other day) allowed
- No concurrent fluconazole or lithium
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Complete blood count normal
- Platelet count normal
Hepatic - AST normal
- Bilirubin normal
- Alkaline phosphatase normal
Renal Cardiovascular - No active ischemic heart disease
- No New York Heart Association class III or IV heart disease
- No myocardial infarction within the past 6 months
- No symptomatic arrhythmia
- No symptomatic peripheral vascular disease or carotid disease that would preclude study participation
Pulmonary - No aspirin-sensitive asthma
Gastrointestinal - No history of inflammatory bowel disease
- No history of upper gastrointestinal bleeding
- No history of duodenal or gastric ulcer
Other - No known hypersensitivity to any COX-2 inhibitor, NSAIDs, aspirin, or sulfonamides
- No non-colorectal malignancy within the past 5 years except carcinoma in situ of the cervix, melanoma in situ, or basal cell or squamous cell skin cancer
- No other disease that would preclude study participation
- No psychiatric disorders, including history of clinical depression or addictive disorders, that would preclude giving informed consent or long-term compliance
- No rheumatologic or skeletal disorders requiring chronic NSAIDs or steroid therapy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Expected Enrollment A total of 1,200 patients (600 per treatment arm) will be accrued for this study within 2.5 years. Outline This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to gender, tumor stage (T1 vs T2), age (≤ 49 vs 50 to 59 vs ≥ 60 years), and current aspirin use (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral celecoxib twice daily for 3 years.
- Arm II: Patients receive oral placebo twice daily for 3 years.
In both arms, treatment continues in the absence of unacceptable toxicity or the diagnosis of invasive colon cancer, carcinoma in situ of the colon or rectum, or a non-colon primary cancer. Quality of life is assessed at baseline and then at 6, 12, 24, 36, and 42 months. Patients are followed at 6 months and at 2 years.
Trial Contact Information
Trial Lead Organizations National Surgical Adjuvant Breast and Bowel Project | | | Richard Goldberg, MD, Principal investigator | | | |
Registry Information | | Official Title | | Celecoxib Polyp Prevention Trial in Participants with Resected Stage I Colon Cancer | | Trial Start Date | | 2004-07-01 | | Registered in ClinicalTrials.gov | | NCT00087256 | | Date Submitted to PDQ | | 2004-06-01 | | Information Last Verified | | 2005-08-11 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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