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Phase II Double-Blind, Placebo Controlled, Randomized Study Of Celecoxib, A Selective COX-2 Inhibitor, In Oral Premalignant Lesions


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Phase II Double-Blind, Placebo Controlled, Randomized Study Of Celecoxib, A Selective COX-2 Inhibitor, In Oral Premalignant Lesions


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Prevention

Principal Investigator

Jay O. Boyle, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

00-111

NCT ID:

NCT00014404

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • lip and oral cavity cancer
  • Head and Neck Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Weill Medical College of Cornell UniversityNew York, New York  10021