|
Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps Clinical research trials and Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps. Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps clinical trial. Subjects frequently obtain the most expert healthcare possible for their Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps  Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps
Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps
For Condition: Rectal Cancer,Colon Cancer
Status: No longer recruiting
Sponsor(s): Chao Family Comprehensive 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. The use of eflornithine and sulindac may be an effective way to prevent the development of colorectal cancer in patients who have had surgery to remove benign colorectal polyps. PURPOSE: Randomized, double-blinded, phase II trial to determine the effectiveness of eflornithine plus sulindac compared to a placebo in preventing colorectal cancer in patients who have had surgery to remove benign colorectal polyps.
Details: OBJECTIVES: - Compare the efficacy of eflornithine (DFMO) and sulindac vs placebo in modulating a panel of surrogate endpoint biomarkers (SEB) of particular relevance in colorectal neoplasia, including quantitative histopathology, uninduced apoptosis, proliferative (Ki67) and preneoplastic (CEA, sialyl-TN, p53, and bcl-2) features, and polyamine and PGE2 levels in patients with at least one previously resected colorectal adenoma. - Determine the relationship between the modulation of SEB in flat mucosa and the development of interval incident colorectal adenomas in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to aspirin use (yes vs no) and participating center. Patients receive oral placebo daily for the first 4 weeks. Patients who are compliant and take the placebo 5 to 7 days each week are randomized to one of two treatment arms. - Arm I: Patients receive oral sulindac and oral eflornithine (DFMO) daily. - Arm II: Patients receive oral placebo daily. Treatment continues for 3 years in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: Approximately 240 patients (120 per treatment arm) will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 40 Years/80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - At least 1 prior resected colorectal adenoma within the past 5 years - At least 3 mm in size - No personal or family history of familial adenomatous polyposis PATIENT CHARACTERISTICS: Age: - 40 to 80 Performance status: - SWOG 0-1 Life expectancy: - Not specified Hematopoietic: - Hematocrit at least 35% - WBC at least 4,000/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin no greater than 2.0 mg/dL - AST and ALT no greater than 2 times normal Renal: - Creatinine no greater than 1.5 mg/dL - No greater than 1+ protein, 0-3 casts, and 0-5 WBCs and RBCs in urine Gastrointestinal: - No requirement for special diet or additives - No diet that would preclude taking study medications - No gastric or duodenal ulcer within the past year - No inflammatory bowel disease Other: - No more than 20 dB hearing loss for age at any frequency - No prior or concurrent invasive cancer within the past 5 years except nonmelanomatous skin cancer, melanoma in situ, stage I cervical cancer, stage I colon cancer, or stage 0 chronic lymphocytic leukemia - No severe metabolic disorder or other acute or chronic diseases - No history of or predisposition to abnormal wound healing or repair - No allergies to nonsteroidal anti-inflammatories or eflornithine - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No concurrent chemotherapy Endocrine therapy: - No concurrent corticosteroids Radiotherapy: - No concurrent radiotherapy Surgery: - See Disease Characteristics Other: - No other concurrent nonsteroidal anti-inflammatories or anticoagulants administered on a regular or predictable intermittent basis - No concurrent aspirin greater than 81 mg per day or 325 mg twice a week for cardiovascular disease prophylaxis - No concurrent calcium supplements greater than 500 mg/day
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrankMeyskens, Study Chair, Chao Family Comprehensive Cancer Center
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Arizona Cancer Center
Tucson, Arizona, 85724-5024
United States
Veterans Affairs Medical Center - Loma Linda (Pettis)
Loma Linda, California, 92357
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Additional Information:
Study ID Numbers: CDR0000067922; NCI-P00-0150,UCIRVINE-97-05
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005882
Other Rectal Cancer Studies:
1. Sulindac and Plant Compounds in Preventing Colon Cancer
2. Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer
3. Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer
4. Genetic Study of Patients and Families With a History of Colorectal Cancer
5. Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
Related Studies:
Other Rectal Cancer Clinical Trials
Other California Clinical Trials
Other Loma Linda Clinical Trials
Eflornithine Plus Sulindac in Preventing Colorectal Cancer in Patients Who Have Had Surgery to Remove Benign Colorectal Polyps
|
|
|
|
|
|
|
|
