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

Conditions: Lung Cancer

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.

objectives: * compare the effect of a smoking cessation intervention comprising behavior intervention and nicotine replacement with or without bupropion on 12-month quit rates in patients with completely resected stage i or ii non-small cell lung cancer who are current smokers. * compare the predictors of smoking cessation success in patients treated with these regimens. * determine the relationship between smoking cessation and standard outcome measures (e.g., second malignancies, survival, and symptom status) in patients treated with these regimens. * compare the effect of these treatment regimens on emotional functioning in these patients. outline: this is a randomized, double-blind, multicenter study. patients are stratified according to gender, prior neoadjuvant or concurrent adjuvant chemotherapy and/or radiotherapy (yes vs no), and time since prior surgery (less than 6 months vs 6 to 12 months vs more than 12 months). patients are randomized to 1 of 2 arms. all patients receive behavioral intervention comprising smoking cessation advice and education on day 1. patients quit smoking on day 8. patients then receive a nicotine transdermal patch once daily on days 8-77. * arm i: patients receive oral bupropion once daily on days 1-3 and twice daily on days 4-77. * arm ii: patients receive oral placebo as in arm i. patients are followed at 3, 6, and 12 months and then annually for 10 years. projected accrual: a total of 468 patients (234 \[117 men and 117 women\] per arm) will be accrued for this study within 3 years.

Eligibility 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

Keywords: non-small cell lung cancer stage i non-small cell lung cancer stage ii non-small cell lung cancer