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	Treatment or Intervention	Phase
lip and oral cavity cancer prevention of oral cancer	Drug: chemoprevention of cancer  Procedure: cancer prevention intervention  Drug: celecoxib	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      Weill Medical College of Cornell University, New York,  New York,  10021,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Study chairs or principal investigators

Jay O Boyle,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000068541; MSKCC-00111; NCI-G01-1930
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  April 10, 2001
ClinicalTrials.gov Identifier:  NCT00014404
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08