Celecoxib and/or EKB-569 in Preventing Oral Cancer in Patients With Oral Leukoplakia
This study is not yet open for patient recruitment.
Sponsored by: |
M.D. Anderson Cancer Center
|
Information provided by: |
National Cancer Institute (NCI) |
Purpose
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer.
Celecoxib and/or EKB-569 may be effective in preventing the development of oral cancer in patients who have oral leukoplakia.
PURPOSE: Randomized clinical trial to study the effectiveness of celecoxib and/or EKB-569 in preventing oral cancer in patients
who have oral leukoplakia.
Condition
|
Treatment or Intervention |
lip and oral cavity cancer Salivary Gland Cancer Precancerous Condition
|
Drug: EKB-569 Drug: celecoxib Procedure: biological response modifier therapy Procedure: cancer prevention intervention Procedure: chemoprevention of cancer Procedure: enzyme inhibitor therapy Procedure: prostaglandin inhibition Procedure: protein tyrosine kinase inhibitor therapy
|
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Oral Cancer; Salivary Gland Disorders
Study Type: Interventional
Study Design: Prevention
Official Title: Randomized Study of Celecoxib and EKB-569, as Monotherapy or in Combination, For Prevention of Oral Cancer in Patients With
Aneuploid Oral Leukoplakia
Further Study Details:
OBJECTIVES: Primary
- Compare the incidence of oral cancer in patients with aneuploid premalignant lesions in the oral cavity treated with celecoxib
and EKB-569 vs celecoxib alone vs EKB-569 alone vs placebo.
Secondary
- Correlate the size, number, and appearance of oral premalignant lesions with cancer risk in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Correlate molecular markers with oral cancer development in patients treated with these regimens.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to Nordic
country of participation and cardioprotective acetylsalicylic acid use (yes vs no). Patients are randomized to 1 of 4 treatment
arms.
- Arm I: Patients receive oral celecoxib twice daily and oral placebo once daily.
- Arm II: Patients receive oral EKB-569 once daily and oral placebo twice daily.
- Arm III: Patients receive oral celecoxib twice daily and oral EKB-569 once daily.
- Arm IV: Patients receive one oral placebo twice daily and another oral placebo once daily. In all arms, treatment continues
for 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed at every 3 months for 2 years and then every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 360 patients (90 per treatment arm) will be accrued for this study within 2-3 years.
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
DISEASE CHARACTERISTICS:
- Diagnosis of oral aneuploid premalignant lesion within the past 3 months
- Dysplastic white or red patches in the oral cavity with DNA aneuploidy determined by high resolving image cytometry
- Must have sufficient lesion to biopsy
- No prior or active head and neck cancer or lung cancer
- No known metastases to the head and neck area from other tumors
PATIENT CHARACTERISTICS: Age
Performance status
- ECOG 0-1 OR
- Karnofsky 80-100%
Life expectancy
Hematopoietic
- WBC > 3,000/mm^3
- Platelet count > 125,000/mm^3
- Hemoglobin normal
Hepatic
- AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 1.5 times ULN
- Bilirubin ≤ 1.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
- Calcium normal
- Glucose normal
- Phosphate normal
- Urea normal
- Uric acid normal
Cardiovascular
- No active coronary artery disease
- No unstable angina
- No uncontrolled hypertension
- No myocardial infarction within the past 6 months
- No congestive heart failure within the past 6 months
- No cardiac arrhythmia requiring antiarrhythmic therapy
Pulmonary
- No asthma
- No active chronic obstructive pulmonary disease
- No other moderate to severe respiratory illness within the past 6 months
Gastrointestinal
- No history of gastrointestinal bleeding or perforation
- No peptic ulcer disease without bleeding
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known hypersensitivity to NSAIDs, sulfonamides, or cyclo-oxygenase-2 inhibitors
- No medical or psychological condition or other reason that would preclude study participation
- Sodium normal
- Potassium normal
- Magnesium normal
- CO_2 content normal
- Chloride normal
- No other cancer within the past 2 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
- No concurrent adrenocorticosteroids
Radiotherapy
Surgery
Other
- More than 3 months since prior participation in any other experimental therapy study
- More than 14 days since prior routine non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin > 100 mg/day
- No concurrent fluconazole, lithium, warfarin, or NSAIDs
- Concurrent aspirin ≤ 100 mg/day allowed
Location
Information
Study chairs or principal investigators
Scott Michael Lippman, MD, FACP, Principal Investigator, M.D. Anderson Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000377364; MDA-2003-0824; MDA-NRH-2003-16
Record last reviewed:
September 2004
Record first received:
August 4, 2004
ClinicalTrials.gov Identifier:
NCT00088842Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-20