Lung Cancer Clinical Trial
Oltipraz in the Prevention of Lung Cancer in People Who Smoke
Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer.
PURPOSE: Randomized phase I trial to study the effectiveness of oltipraz in preventing lung cancer in people who smoke.
Full Description
OBJECTIVES:
Determine the effect of oltipraz on the level of BP-7,8-diol-9,10-epoxide (BPDE) DNA adducts in the lung lining cells (macrophages and bronchial epithelial cells) of smokers.
Determine the tolerability and toxicity of this treatment regimen in these patients.
Determine the effect of this treatment regimen on the level of macromolecule adducts in the blood (e.g., BPDE DNA, BPDE hemoglobin, and 8-hydroxy-deoxyguanine), oral lining cells (BPDE DNA), bladder lining cells (4-aminobiphenyl DNA), and lung macrophages (8-hydroxy-deoxyguanine) in these patients.
Determine the effect of this treatment regimen on the change (decrease) in activation of NNK as measured by change (increase) in urinary NNAL plus NNAL glucuronide in these patients.
Determine the effect of this treatment regimen on the oxidative state, glutathione-S-transferase activity, and superoxide dismutase 3 and phase II enzymes in the lungs and blood of these patients.
Compare the changes in oxidative state and phase II enzymes with changes in adduct levels in the lungs and blood of these patients.
Determine the correlation between oltipraz-induced changes in phase II enzymes and adduct formation with genotypic variation in glutathione-S-transferase isozymes in these patients.
Compare the response to this treatment regimen in terms of oxidative state, phase II enzymes, and adduct formation in the lungs vs the blood in these patients.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of three treatment arms.
Arm I: Patients receive an oral placebo weekly.
Arm II: Patients receive low-dose oral oltipraz weekly.
Arm III: Patients receive high-dose oral oltipraz weekly. Treatment continues for 12 weeks in the absence of unacceptable toxicity.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 66 patients (22 per treatment arm) will be accrued for this study within 21 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Current cigarette smokers
At least 20 cigarettes a day
No variation of more than 10 in the number of cigarettes smoked per day within the past 3 months
At least 10 years of smoking any amount
Failed to stop smoking after at least one attempt to quit within the last 3 years
Prior stage I non-small cell lung cancer allowed if surgically resected with at least a lobectomy
No concurrent evidence of lung cancer
Willing to undergo 2 bronchoscopies
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
ECOG 0
Life expectancy:
Not specified
Hematopoietic:
CBC normal
Hemostasis normal
Hepatic:
PT and PTT normal
Renal:
Blood chemistries normal
Nonfasting glucose no greater than 200 mg/dL
No active renal disease
No urinary tract infection by urinalysis (trace protein allowed)
Cardiovascular:
EKG normal
No coronary artery disease requiring continuous medication
Pulmonary:
Chest radiograph normal (postsurgical changes allowed)
No acute or significant chronic abnormality
FEV1 greater than 1.8 L or 75% predicted
No chronic obstructive pulmonary disease requiring continuous medication
Other:
No known hypersensitivity or prior adverse reaction to oltipraz
No inmates or prisoners
No medical or psychological condition that would preclude study (e.g., acute psychosis)
No prior malignancy except nonmelanomatous skin cancer, cervical dysplasia, or curatively treated stage I or II cancer of the head and neck
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
At least 3 months since prior potential chemoprevention agent (e.g., oltipraz, retinoids, or acetylcysteine)
Endocrine therapy:
Not specified
Radiotherapy:
Not specified
Surgery:
See Disease Characteristics
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There are 2 Locations for this study
Chicago Illinois, 60611, United States
Durham North Carolina, 27710, United States
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