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Phase III Randomized Study of Smoking Cessation Intervention With or Without Bupropion in Patients With Completely Resected Stage I or II Non-Small Cell Lung Cancer Who are Current Smokers
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
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Protocol IDs
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Phase III
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Prevention
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Completed
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18 and over
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NCI
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SWOG-S0002 CALGB-79807, ECOG-S0002, NCI-P02-0215, NCT00032084
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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.
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: 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: Performance status: Life expectancy: Hematopoietic: Hepatic: Renal: 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 |
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Cancer and Leukemia Group B | | | Philip Hoffman, MD, Protocol chair | | | |
Eastern Cooperative Oncology Group | | | James Stevenson, MD, Protocol chair(Contact information may not be current) | | | |
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 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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