Clinical trial · Interventional
Oltipraz in the Prevention of Lung Cancer in People Who Smoke
Clinical Phase I Multiple-Dose Safety Research Study of Oltipraz in Smokers
NCT00006457CI-TRIAL-00007152completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oltipraz | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.