S0002 - A Program to Quit Smoking With or Without Bupropion in Treating Patients With Stage I or II Non-Small Cell Lung Cancer Who Have Undergone Surgery

• Status: Terminated
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: A program that includes bupropion may be more effective in helping early-stage lung cancer patients to quit smoking. It is not yet known if a program to quit smoking is more effective with or without bupropion.

PURPOSE: Randomized phase III trial to determine the effectiveness of a program to quit smoking with or without bupropion in treating patients who have undergone surgery for stage I or stage II non-small cell lung cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborators: Cancer and Leukemia Group B; Eastern Cooperative Oncology Group; National Cancer Institute (NCI)
• Treatments: Bupropion; Nicotine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of stage I or II non-small cell lung cancer with complete resection of all disease

• Must be free of recurrent or progressive disease

• Current smoker defined as:

• Smoked at least 100 cigarettes in entire life AND

• Currently smoking some days or every day

• Must establish a quit date that falls within 30 days after registration, but 7 days after physician advice and start of bupropion or placebo therapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Cardiovascular:

• Not within an immediate post-infarction period

• No uncontrolled arrhythmias

• No unstable angina

• No uncontrolled hypertension (unstable blood pressure, diastolic pressure 90 mm Hg or greater)

Other:

• Must be able to read, speak, and understand English

• Must be willing to allow testing of saliva for cotinine levels

• No history of seizures

• No history of eating disorders

• No known drug-drug interactions between nicotine patch and/or bupropion and patient's current or planned medications including chemotherapy and antiemetics

• No concurrent psychiatric diagnosis that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Concurrent adjuvant chemotherapy allowed

Endocrine therapy:

• No concurrent systemic steroids

Radiotherapy:

• Concurrent adjuvant radiotherapy allowed

Surgery:

• See Disease Characteristics

• Recovered from prior surgery

Other:

• Prior neoadjuvant therapy allowed

• At least 14 days since prior medications containing bupropion (e.g., Wellbutrin or Wellbutrin SR)

• No other concurrent medications that contain bupropion (e.g., Wellbutrin or Wellbutrin SR)

• No concurrent monoamine oxidase inhibitors

• No concurrent medications that lower seizure threshold (e.g., antipsychotics, antidepressants, or theophylline)

• No other concurrent nicotine replacement therapy