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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
This study has been completed.
Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00032084
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: bupropion hydrochloride
Drug: nicotine
Procedure: psychosocial assessment and care
Procedure: smoking cessation intervention
Phase III

MedlinePlus related topics: Cancer Lung Cancer Quitting Smoking Smoking
Drug Information available for: Bupropion hydrochloride Bupropion Nicotine polacrilex Nicotine tartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2002
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032084

  Show 176 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Investigators
Study Chair: Ellen R. Gritz, PhD M.D. Anderson Cancer Center
Study Chair: Philip C. Hoffman, MD University of Chicago
Study Chair: James Stevenson, MD Presbyterian Medical Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069256, SWOG-S0002, CALGB-79807, ECOG-S0002, NCI-P02-0215
Study First Received: March 8, 2002
Last Updated: November 26, 2008
ClinicalTrials.gov Identifier: NCT00032084  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Nicotine polacrilex
Non-small cell lung cancer
Carcinoma
Smoking
Dopamine
Respiratory Tract Diseases
Lung Neoplasms
Nicotine
Lung Diseases
Bupropion
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Respiratory Tract Neoplasms
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009