S0002 - 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

SWOG Cancer Research Network

Status and phase: Terminated; Phase 3

Conditions: Lung Cancer

Treatments: Procedure: psychosocial assessment and care; Drug: nicotine; Behavioral: smoking cessation intervention; Drug: bupropion hydrochloride

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00032084

CDR0000069256

ECOG-S0002 (Other Identifier)

CALGB-79807 (Other Identifier)

NCI-P02-0215 (Other Identifier)

SWOG-S0002 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

Behavioral Intervention + Placebo

Placebo Comparator group

Description:

Smoking cessation intervention , nicotine replacement, psychosocial assessment and care, and placebo.

Treatment:

Procedure: psychosocial assessment and care

Behavioral: smoking cessation intervention

Drug: nicotine

Behavioral Intervention + Bupropion

Active Comparator group

Description:

Smoking cessation intervention, nicotine replacement, psychosocial assessment and care, and bupropion hydrochloride .

Treatment:

Procedure: psychosocial assessment and care

Behavioral: smoking cessation intervention

Drug: bupropion hydrochloride

Drug: nicotine