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 - Full Text View

Sponsor:	Southwest Oncology Group
Collaborators:	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	Behavioral: smoking cessation intervention Drug: bupropion hydrochloride Drug: nicotine Procedure: psychosocial assessment and care	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Quitting Smoking Smoking Surgery

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

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

National Cancer Institute (NCI)

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000069256, SWOG-S0002, CALGB-79807, ECOG-S0002, NCI-P02-0215
Study First Received:	March 8, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00032084 History of Changes
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

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Thoracic Neoplasms
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
Carcinoma
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Bupropion
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Carcinoma, Non-Small-Cell Lung
Antidepressive Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009