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

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