Oltipraz in the Prevention of Lung Cancer in People Who Smoke

NCT00006457 | Completed Phase 1

• 4 other identifiers: NCI 00L1NU-00L1DUMC-000346-00-2NCI-P00-0167
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lung Cancer

Keywords

non-small cell lung cancer; small cell lung cancer

Interventions

oltipraz DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

oltipraz

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Raymond C. Bergan, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2000
• First Posted: May 30, 2003
• Study Start: August 1, 2000
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2004
• Last Updated: June 11, 2012

Record last verified: 2012-06

Locations

US (2)