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Trial record 42 of 2104 for:    Oral Cancer | NIH

Celecoxib in Treating Patients With Precancerous Lesions of the Mouth

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ClinicalTrials.gov Identifier: NCT00014404
Recruitment Status : Completed
First Posted : January 7, 2004
Last Update Posted : January 16, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: celecoxib Phase 2

Detailed Description:

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.

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.


Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
Official Title: Phase II Double-Blind, Placebo Controlled, Randomized Study Of Celecoxib, A Selective COX-2 Inhibitor, In Oral Premalignant Lesions
Study Start Date : October 2000
Actual Primary Completion Date : January 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib





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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

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


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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014404


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Jay O. Boyle, MD Memorial Sloan Kettering Cancer Center

Publications of Results:
ClinicalTrials.gov Identifier: NCT00014404     History of Changes
Other Study ID Numbers: 00-111
MSKCC-00111
NCI-G01-1930
First Posted: January 7, 2004    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
lip and oral cavity cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents