Official Title: “Smoking Cessation Intervention (Including Bupropion-Zyban Versus Placebo) for Completely Resected Stage I and II Non-Small Cell Lung Cancer Survivors Who Are Current Smokers”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double-Blind, Active Control

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.

Intervention(s) in this Clinical Trial

• Drug: bupropion hydrochloride
• Drug: nicotine
• Procedure: psychosocial assessment and care

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Southwest Oncology Group

Overall Clinical Trial Officials and Contacts

Ellen R. Gritz, PhD Study Chair M.D. Anderson Cancer Center  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00032084

Study ID Number: CDR0000069256

ClinicalTrials.gov Identifier: NCT00032084

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database