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Celecoxib and/or Selenium in Treating Patients With Adenomatous Colorectal Polyps Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Celecoxib and/or Selenium in Treating Patients With Adenomatous Colorectal Polyps conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Celecoxib and/or Selenium in Treating Patients With Adenomatous Colorectal Polyps Clinical research trials and Celecoxib and/or Selenium in Treating Patients With Adenomatous Colorectal Polyps medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Celecoxib and/or Selenium in Treating Patients With Adenomatous Colorectal Polyps. Celecoxib and/or Selenium in Treating Patients With Adenomatous Colorectal Polyps Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Celecoxib and/or Selenium in Treating Patients With Adenomatous Colorectal Polyps clinical trial. Participants frequently obtain the most expert healthcare available for their Celecoxib and/or Selenium in Treating Patients With Adenomatous Colorectal Polyps condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Celecoxib and/or Selenium in Treating Patients With Adenomatous Colorectal Polyps  Celecoxib and/or Selenium in Treating Patients With Adenomatous Colorectal Polyps
Celecoxib and/or Selenium in Treating Patients With Adenomatous Colorectal Polyps
For Condition: Colon Cancer,Rectal Cancer
Status: Recruiting
Sponsor(s): Arizona Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib and selenium may be effective in preventing the recurrence of adenomatouscolorectalpolyps. It is not yet known whether combining celecoxib with selenium is more effective than either celecoxib or selenium alone in preventing the recurrence of adenomatous colorectal polyps. PURPOSE: Randomizedphase III trial to compare the effectiveness of celecoxib combined with selenium with that of either celecoxib or selenium alone in preventing the recurrence of polyps in patients who have adenomatous colorectal polyps.
Details: OBJECTIVES: - Compare the effects of celecoxib vs selenium vs the combination of celecoxib and selenium vs placebo on the recurrence of adenomatous colorectal polyps, in terms of histologic type, number, size, and location, in patients with adenomatous colorectal polyps. - Compare the effect of these regimens on carcinogenesis, in terms of gene methylation patterns and cyclooxygenase expression, in these patients. - Compare the type, incidence, and outcome of side effects in patients treated with these regimens. - Determine patient adherence to long-term treatment with these regimens. - Determine whether adherence to protocol procedures, dietary intake, smoking history, medication intake, and physical activity in these patients affects the relationships of these regimens to this study. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to use of low-dose (81 mg/day or less) aspirin (yes vs no). Patients are randomized to 1 of 4 treatment arms. - Arm I: Patients receive oral celecoxib and oral selenium once daily. - Arm II: Patients receive oral celecoxib and oral placebo once daily. - Arm III: Patients receive oral selenium and oral placebo once daily. - Arm IV: Patients receive oral placebo once daily. In all arms, treatment continues for up to 3 years in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up colonoscopy 2.5-3 years after baseline colonoscopy. PROJECTED ACCRUAL: A total of 1,600 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional,�Prevention
Minimum Age/Maximum Age: 40 Years/80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed colorectal adenomatous polyps - Meets the following criteria by colonoscopy (performed within the past 6 months): - Cecum was totally visualized or reached - At least 90% visualization of colon surface area - Removed at least 1 adenomatous polyp of at least 3 mm in size during procedure - Removed no more than 10 adenomatous polyps of any size by endoscopy - All other neoplastic and non-neoplastic colon polyps must have been completely removed (except for diminutive [less than 3 mm] sessile rectal polyps) - No prior diagnosis of any of the following: - Colorectal cancer - Familial adenomatous polyposis - Ulcerative colitis - Crohn's disease - Hereditary non-polyposis colon cancer (HNPCC), defined as: - Histologically confirmed colorectal cancer in at least 3 relatives, 1 of whom is a first-degree relative of the other 2 - Disease occurrence in at least 2 consecutive generations - Colorectal cancer diagnosis in at least 1 family member who is less than 50 years of age - Patients with a family history of colorectal cancer but who are not diagnosed with HNPCC are allowed - No more than 1 prior segmental colon resection PATIENT CHARACTERISTICS: Age - 40 to 80 Performance status - SWOG 0-1 Life expectancy - Not specified Hematopoietic - Hemoglobin > 11 g/dL - WBC 3,000 - 11,000/mm^3 Hepatic - AST and ALT < 2 times upper limit of normal - Bilirubin < 2.0 mg/dL Renal - Creatinine < 1.9 mg/dL - Creatinine clearance 25% of normal Cardiovascular - No unstable* cardiac disease despite medication (e.g., diuretics or digitalis) - No uncontrolled hypertension (i.e., systolic blood pressure 170 mm Hg and/or diastolic blood pressure 110 mm Hg) despite medication NOTE: *Unstable defined as unable to walk across the room without chest pain or shortness of breath Other - Not pregnant or nursing - Fertile patients must use effective contraception for at least 2 months before and during study treatment - Resident of a clinical center metropolitan area or obtaining regular health care in a clinical metropolitan area for at least 6 months out of the year - Must be able to swallow pills - No substantially worsened asthma secondary to aspirin or other NSAIDs requiring hospitalization or an emergency room visit - No unexpected weight loss of 10% or more within the past 6 months - No prior rheumatoid arthritis - No poorly controlled diabetes mellitus despite medication, defined as: - Blood sugar level 200 mg/dL on more than half of the readings taken within the past month - No prior anaphylactic reaction to aspirin, other NSAIDs, or sulfa drugs, such as the following: - Thickening of the tongue requiring steroids - Drop in blood pressure requiring medication or hospitalization - Shortness of breath requiring oxygen - Hives - Rash - No invasive malignancy within the past 5 years that required medical excision, radiotherapy, or chemotherapy except basal cell or squamous cell carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent drugs that regulate the immune system Chemotherapy - No concurrent chemotherapy Endocrine therapy - No concurrent prednisone of more than 10 mg/day Radiotherapy - No concurrent radiotherapy Surgery - See Disease Characteristics Other - At least 1 month since prior fluconazole - Prior enrollment in another adenoma prevention study allowed - No concurrent fluconazole - No concurrent lithium - No concurrent chronic use (daily use for at least 1 month) of cyclooxygenase-2 (COX-2) inhibitors - No concurrent non-steroidal anti-inflammatory drugs (NSAIDs) - No usage for more than 7 consecutive days OR for more than a total of 21 days/year - No concurrent enrollment in another research study using pharmacological cancer drugs, a COX-2 inhibitor, or selenium - No other concurrent selenium unless dosage is 50 µg/day or less - Concurrent routine aspirin (81 mg/day or less) allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
M.Lance, Principal Investigator, Arizona Cancer Center
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Dennis Ahnen 720-848-0300
Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tuscon, Arizona, 85724
United States
Recruiting M. Lance 520-626-4768
Baylor University Medical Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting C. Boland 214-820-2692
Mayo Clinic Scottsdale *Recruiting*
Scottsdale, Arizona, 85259
United States
Recruiting Russell Heigh 480-301-6990
Additional Information:
Study ID Numbers: CDR0000353185; UARIZ-HSC-00142
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078897
Other Colon Cancer Studies:
1. Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis.
2. Interleukin-12 in Treating Patients With Cancer in the Abdomen
3. Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer
4. Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer
5. Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
Related Studies:
Other Colon Cancer Clinical Trials
Other Arizona Clinical Trials
Other Scottsdale Clinical Trials
Celecoxib and/or Selenium in Treating Patients With Adenomatous Colorectal Polyps
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