Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Prevention Completed 18 and over NCI SWOG-S0002 CALGB-79807, ECOG-S0002, NCI-P02-0215, NCT00032084

Objectives

1. 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.
2. Compare the predictors of smoking cessation success in patients treated with these regimens.
3. Determine the relationship between smoking cessation and standard outcome measures (e.g., second malignancies, survival, and symptom status) in patients treated with these regimens.
4. Compare the effect of these treatment regimens on emotional functioning in these patients.

Entry 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

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

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

Expected Enrollment

A total of 468 patients (234 [117 men and 117 women] per arm) will be accrued for this study within 3 years.

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Ellen R. Gritz, PhD, Protocol chair		Ph: 713-745-3187; 800-392-1611

Cancer and Leukemia Group B

Philip Hoffman, MD, Protocol chair		Ph: 773-702-0963; 888-824-0200 Email: phoffman@medicine.bsd.uchicago.edu

Eastern Cooperative Oncology Group

James Stevenson, MD, Protocol chair(Contact information may not be current)		Ph: 215-662-8947

Registry Information
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
Trial Start Date		2002-01-01
Registered in ClinicalTrials.gov		NCT00032084
Date Submitted to PDQ		2002-01-25
Information Last Verified		2004-02-11
NCI Grant/Contract Number		CA37429