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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

This study has been terminated.
(This study was closed early due to poor accrual)
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00032084
First received: March 8, 2002
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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:

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • To compare the effect on 12 month quit rates of adding an anti-depressant versus placebo in a double blind to an intervention and nicotine replacement in complete resected Stage I and II non-small cell lung cancer patients who are current smokers [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess predictors of successful cessation in male and female patients. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To explore the relationship between smoking cessation and standard outcome measures. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To compare the effect on emotional functioning of adding bupropion to a behavioral intervention plus nicotine replacement in this patient population. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • To explore the relationship of nicotine dependence genetic markers to 12 month quit rates by way of the dopamine D2 receptor gene (DRD2). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To assess the relationship among metabolic polymorphism genes associated with lung cancer susceptibility in smokers who are lung cancer patients. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To examine the relationship of nicotine susceptibility markers to 1 month quit rate, gender and pharmacologic (nicotine replacement therapy and either placebo or bupropion. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: January 2002
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Behavioral Intervention + Placebo
Smoking cessation intervention , nicotine replacement, psychosocial assessment and care, and placebo.
 Behavioral: smoking cessation intervention
Physician will deliver the smoking cessation advice, reinforce the established quit date (no sooner than seven days after starting bupropion/placebo), and will distribute patient educational materials and all pharmacotherapy
Drug: nicotine
21 mg patch/day for Weeks 2-7; 14 mg patch/day for Weeks 8-9; 7 mg patch/day for Weeks 10-11.
Other Name: Nicoderm CQ
Procedure: psychosocial assessment and care
The nurse/CRA will debrief the patients after the brief physician intervention and will follow-up with a series of 5 phone calls to provide booster advice. All advice will be based on the stage of change model (i.e., tailored to the patient's readiness to quit and/or stay off cigarettes).
Active Comparator: Behavioral Intervention + Bupropion
Smoking cessation intervention, nicotine replacement, psychosocial assessment and care, and bupropion hydrochloride .
 Behavioral: smoking cessation intervention
Physician will deliver the smoking cessation advice, reinforce the established quit date (no sooner than seven days after starting bupropion/placebo), and will distribute patient educational materials and all pharmacotherapy
Drug: bupropion hydrochloride
150 mg/day on Days 1-3, 300 mg/day on Day 4-77
Other Name: Zyban
Drug: nicotine
21 mg patch/day for Weeks 2-7; 14 mg patch/day for Weeks 8-9; 7 mg patch/day for Weeks 10-11.
Other Name: Nicoderm CQ
Procedure: psychosocial assessment and care
The nurse/CRA will debrief the patients after the brief physician intervention and will follow-up with a series of 5 phone calls to provide booster advice. All advice will be based on the stage of change model (i.e., tailored to the patient's readiness to quit and/or stay off cigarettes).

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

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00032084     History of Changes
Other Study ID Numbers: CDR0000069256, SWOG-S0002, CALGB-79807, ECOG-S0002, NCI-P02-0215
Study First Received: March 8, 2002
Last Updated: March 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nicotine
Nicotine polacrilex
Bupropion
Ganglionic Stimulants
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013