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Celecoxib in Treating Patients With Precancerous Lesions of the Mouth Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Celecoxib in Treating Patients With Precancerous Lesions of the Mouth conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Celecoxib in Treating Patients With Precancerous Lesions of the Mouth Clinical research trials and Celecoxib in Treating Patients With Precancerous Lesions of the Mouth health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Celecoxib in Treating Patients With Precancerous Lesions of the Mouth. Celecoxib in Treating Patients With Precancerous Lesions of the Mouth Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Celecoxib in Treating Patients With Precancerous Lesions of the Mouth clinical trial. Human subjects often get the best healthcare possible for their Celecoxib in Treating Patients With Precancerous Lesions of the Mouth condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Celecoxib in Treating Patients With Precancerous Lesions of the Mouth  Celecoxib in Treating Patients With Precancerous Lesions of the Mouth
Celecoxib in Treating Patients With Precancerous Lesions of the Mouth
For Condition: prevention of oral cancer,lip and oral cavity cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib may be an effective way to prevent the further development of precancerous lesions in the mouth. PURPOSE: Randomized phase II trial to compare the effectiveness of different regimens of celecoxib in treating patients who have precancerous lesions in the mouth.
Details: OBJECTIVES: I. Determine the efficacy of celecoxib, in terms of clinical response and histological response, in patients with oral premalignant lesions. II. Evaluate the safety of chronic multiple dosing of celecoxib in these patients. PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to premalignant risk (early vs advanced). Patients in each stratum are randomized to 1 of 3 treatments arms. Arm I: Patients receive lower-dose oral celecoxib twice daily. Arm II: Patients receive higher-dose oral celecoxib twice daily. Arm III: Patients receive oral placebo twice daily. Treatment continues in all 3 arms for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 18, 24, and 26 weeks. PROJECTED ACCRUAL: A total of 84 patients (42 per stratum, 14 per arm) will be accrued for this study within 6 months.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed index oral premalignant lesion(s) 8 mm or greater in size; Not biopsied within the past 6 weeks; Early premalignant lesion with atypical cells or mild dysplasia OR Advanced premalignant lesion with moderate or severe dysplasia --Prior/Concurrent Therapy-- - Biologic therapy: At least 3 weeks since prior immunotherapy and recovered; No concurrent immunotherapy - Chemotherapy: At least 3 weeks since prior chemotherapy and recovered; No concurrent chemotherapy - Endocrine therapy: At least 3 weeks since prior hormonal therapy (except hormone replacement therapy for menopause) and recovered; No concurrent hormonal therapy except hormone replacement therapy for menopause; Less than 14 days of oral or IV corticosteroid use within the past 6 months; Less than 30 days of inhaled corticosteroid use within the past 6 months - Radiotherapy: At least 3 weeks since prior radiotherapy and recovered; No concurrent radiotherapy - Surgery: See Disease Characteristics - Other: No prior participation in and withdrawal from this study; At least 3 months since any other prior chemopreventive therapy and recovered; At least 30 days since prior investigational agents; At least 2 weeks since prior beta-carotene at 60 mg/day or more; No concurrent beta-carotene at 60 mg/day or more; No concurrent oral aspirin greater than 100 mg/day; No other concurrent investigational agents; No concurrent fluconazole or lithium; No concurrent chronic NSAIDs or COX-2 inhibitors --Patient Characteristics-- - Age: Over 18 - Performance status: Zubrod 0-1 - Life expectancy: More than 12 weeks - Hematopoietic: Hemoglobin greater than lower limit of normal; WBC greater than 3,000/mm3; Platelet count greater than 125,000/mm3; No significant bleeding disorder - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); AST/ALT no greater than 1.5 times ULN; No chronic or acute hepatic disorder - Renal: BUN no greater than 1.5 times ULN; Creatinine no greater than 1.5 times ULN; No chronic or acute renal disorder - Gastrointestinal: No diagnosis or treatment of esophageal, gastric, pyloric channel, or duodenal ulceration within past 30 days; No prior or active pancreatic disease or inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) - Other: Completed a smoking cessation program, if applicable; No prior hypersensitivity to COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides; No prior invasive cancer within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix; No other concurrent condition that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JayBoyle, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Weill Medical College of Cornell University
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068541; MSKCC-00111,NCI-G01-1930
Study Start Date: October 2000
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014404
Other Lip And Oral Cavity Cancer Studies:
1. Celecoxib in Treating Patients With Precancerous Lesions of the Mouth
Related Studies:
Other lip and oral cavity cancer Clinical Trials
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Celecoxib in Treating Patients With Precancerous Lesions of the Mouth
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