Oltipraz in the Prevention of Lung Cancer in People Who Smoke

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Oltipraz

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