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Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis. Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis. conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis. Clinical research trials and Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis. medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis.. Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis. Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis. clinical trial. Participants oftentimes recieve the finest healthcare available for their Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis. condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), 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 With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis.  Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis.
Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis.
For Condition: Rectal Cancer,Colon Cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: The use of celecoxib with or without eflornithine may be an effective way to prevent colorectal cancer in patients who have familial adenomatous polyposis. PURPOSE: Randomizedphase II trial to compare the effectiveness of celecoxib with or without eflornithine in preventing colorectal cancer in patients who have familial adenomatous polyposis.
Details: OBJECTIVES: - Compare the relative efficacy of celecoxib with or without eflornithine, as evidenced by the percentage change from baseline in the number of polyps in a focal area of the colorectum, in participants with familial adenomatous polyposis of the colorectum. - Compare the tolerability and safety of these preventive regimens in these participants. - Compare the percentage change in polyp size in a focal area of the colorectum in participants after receiving these regimens. - Compare the change in global colorectal polyp burden in participants after receiving these regimens. - Compare whether these regimens prevent polyp formation over a 6-month period in a field cleared of polyps in these participants. - Compare the percentage change in the area of plaque-like duodenal polyps in participants with duodenal disease at baseline. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 arms. - Arm I: Patients receive oral celecoxib twice daily and oral placebo once daily. - Arm II: Patients receive celecoxib as in arm I and oral eflornithine once daily. Treatment in both arms continues for 6 months in the absence of disease progression or unacceptable toxicity. Patients are followed at 1-2 months after end of study therapy. PROJECTED ACCRUAL: A total of 120 patients (60 per arm) will be accrued for this study within 13 months.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of familial adenomatous polyposis (FAP) of the colorectum based on the following: - Meet 1 of the following criteria: - More than 100 polyps - More than 10 polyps and under age 40 - More than 25 polyps and over age 40 - Characteristic family history (autosomal dominant pattern), including 1 of the following: - More than 100 polyps in a first-degree relative - More than 25 polyps in 2 relatives in 2 generations, including a first-degree family member - Genetic diagnosis in a relative - Genetic diagnosis by in vitro synthesized protein or similar assay - No anticipated colectomy within 8 months after randomization - Colonic and/or rectal segment endoscopy documenting 1 of the following: - 5 or more rectal polyps each at least 2 mm in diameter - 5 or more colon polyps each at least 2 mm in diameter, including 1 of the following: - 3 quantifiable colon polyps greater than 3 mm in diameter - 2 quantifiable colon polyps greater than 5 mm in diameter - Duodenal polyps allowed PATIENT CHARACTERISTICS: Age: - See Disease Characteristics - 18 to 65 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - No significant hematologic dysfunction - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10.0 g/dL Hepatic: - No significant hepatic dysfunction - Bilirubin no greater than 2 times upper limit of normal (ULN) - SGOT and SGPT no greater than 1.5 times ULN - Alkaline phosphatase no greater than 1.5 times ULN Renal: - No significant renal dysfunction - Creatinine no greater than 1.5 times ULN Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No clinically significant hearing loss, defined as: - Hearing loss that affects everyday life or for which a hearing aid is required - Abnormal hearing on an air conduction pure tone audiogram (exceeding 95th percentile) - No prior hypersensitivity to cyclooxygenase-2 inhibitors, sulfonamides, NSAIDs, or salicylates - No discrete gastric or duodenal ulcer greater than 5 mm within the past year except Helicobacter pylori-related peptic ulcer disease treated successfully with antibiotics (as documented by an endoscopy) - No invasive malignancy within the past 5 years except stage I or II colon cancer or resected nonmelanomatous skin cancer - No other significant medical or psychiatric problems that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - No chronic adrenocorticosteroids Radiotherapy: - No prior pelvic irradiation Surgery: - See Disease Characteristics - At least 1 year since prior partial or complete colectomy Other: - At least 3 months since prior investigational agents - At least 3 months since prior chronic non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin or celecoxib) - No other concurrent NSAIDs (e.g., aspirin, ibuprofen, or naproxen) - No concurrent warfarin, fluconazole, or lithium
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatrickLynch, Study Chair, M.D. Anderson Cancer Center
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Carol Burke 216-444-6864
St. Mark's Hospital *Recruiting*
Harrow, England, HA1 3UJ
United Kingdom
Recruiting R. Phillips 44-20-8235-4251
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Patrick Lynch 713-794-5073
Additional Information:
Study ID Numbers: CDR0000069278; NCI-P02-0219,MDA-ID-00109
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033371
Other Colon Cancer Studies:
1. Safety Study of 90Y-hMN14 to Treat Colorectal Cancer
2. Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer
3. Celecoxib and/or Selenium in Treating Patients With Adenomatous Colorectal Polyps
4. Conventional Care With or Without Specialized Cancer Care in Treating Patients Receiving Chemotherapy
5. Surgery With or Without Radiofrequency Ablation Followed by Irinotecan in Treating Patients With Colorectal Cancer That is Metastatic to the Liver
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Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis.
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