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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00032084
• Other study ID #: CDR0000069256
• Secondary ID: SWOG-S0002CALGB-
• Status: Terminated
• Phase: Phase 3
• First received: March 8, 2002
• Last updated: March 8, 2013
• Start date: January 2002
• Est. completion date: February 2004

Study information

• Verified date: March 2013
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

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
• 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.

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).

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico School of Medicine Medical Sciences Campus	San Juan
United States	Veterans Affairs Medical Center - Albany	Albany	New York
United States	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico
United States	Veterans Affairs Medical Center - Albuquerque	Albuquerque	New Mexico
United States	Harrington Cancer Center	Amarillo	Texas
United States	Veterans Affairs Medical Center - Amarillo	Amarillo	Texas
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Veterans Affairs Medical Center - Ann Arbor	Ann Arbor	Michigan
United States	Northeast Alabama Regional Medical Center	Anniston	Alabama
United States	Veterans Affairs Medical Center - Asheville	Asheville	North Carolina
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Marlene and Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Veterans Affairs Medical Center - Baltimore	Baltimore	Maryland
United States	Green Mountain Oncology Group	Bennington	Vermont
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Veterans Affairs Medical Center - Biloxi	Biloxi	Mississippi
United States	Cancer Research Center at Boston Medical Center	Boston	Massachusetts
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Veterans Affairs Medical Center - Buffalo	Buffalo	New York
United States	Vermont Cancer Center at University of Vermont	Burlington	Vermont
United States	Cooper University Hospital	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	Veterans Affairs Medical Center - Charleston	Charleston	South Carolina
United States	Martha Jefferson Hospital	Charlottesville	Virginia
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	MBCCOP - University of Illinois at Chicago	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Veterans Affairs Medical Center - Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	NorthEast Oncology Associates	Concord	North Carolina
United States	Veterans Affairs Medical Center - Dallas	Dallas	Texas
United States	CCOP - Dayton	Dayton	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Denver	Colorado
United States	Veterans Affairs Medical Center - Denver	Denver	Colorado
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Veterans Affairs Medical Center - Detroit	Detroit	Michigan
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Veterans Affairs Medical Center - Durham	Durham	North Carolina
United States	Elmhurst Hospital Center	Elmhurst	New York
United States	Veterans Affairs Medical Center - Fargo	Fargo	North Dakota
United States	Cape Fear Valley Health System	Fayetteville	North Carolina
United States	Broward General Medical Center	Fort Lauderdale	Florida
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Fort Wayne Medical Oncology and Hematology, Incorporated	Fort Wayne	Indiana
United States	University of Texas Medical Branch	Galveston	Texas
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin
United States	CCOP - Greenville	Greenville	South Carolina
United States	Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)	Hines	Illinois
United States	Memorial Regional Hospital Comprehensive Cancer Center	Hollywood	Florida
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Veterans Affairs Medical Center - Houston	Houston	Texas
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Veterans Affairs Medical Center - Jackson	Jackson	Mississippi
United States	Queens Cancer Center of Queens Hospital	Jamaica	New York
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Kansas Cancer Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri
United States	Lenoir Memorial Hospital Cancer Center	Kinston	North Carolina
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Veterans Affairs Medical Center - Las Vegas	Las Vegas	Nevada
United States	Norris Cotton Cancer Center at Dartmouth Medical School	Lebanon	New Hampshire
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Veterans Affairs Medical Center - Lexington	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Veterans Affairs Medical Center - Little Rock (McClellan)	Little Rock	Arkansas
United States	Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center	Los Angeles	California
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Veterans Affairs Medical Center - West Los Angeles	Los Angeles	California
United States	Baptist Hospital East - Louisville	Louisville	Kentucky
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	North Shore University Hospital	Manhasset	New York
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	Veterans Affairs Outpatient Clinic - Martinez	Martinez	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Danville Radiation Therapy Center	Memphis	Tennessee
United States	University of Tennessee Cancer Institute	Memphis	Tennessee
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota
United States	MBCCOP - Gulf Coast	Mobile	Alabama
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Veterans Affairs Medical Center - New Orleans	New Orleans	Louisiana
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Mount Sinai Medical Center, NY	New York	New York
United States	New York Weill Cornell Cancer Center at Cornell University	New York	New York
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Virginia Oncology Associates - Norfolk	Norfolk	Virginia
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Veterans Affairs Medical Center - Oklahoma City	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center	Orange	California
United States	Florida Hospital Cancer Institute	Orlando	Florida
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)	Phoenix	Arizona
United States	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Cancer Institute at Oregon Health and Science University	Portland	Oregon
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Veterans Affairs Medical Center - Portland	Portland	Oregon
United States	Lifespan: The Miriam Hospital	Providence	Rhode Island
United States	Ministry Medical Group - Northern Region	Rhinelander	Wisconsin
United States	MBCCOP - Massey Cancer Center	Richmond	Virginia
United States	West Suburban Center for Cancer Care	River Forest	Illinois
United States	Oncology and Hematology Associates of Southwest Virginia, Inc.	Roanoke	Virginia
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Saint Anthony Medical Center	Rockford	Illinois
United States	CCOP - Beaumont	Royal Oak	Michigan
United States	University of California Davis Cancer Center	Sacramento	California
United States	Lakeland Medical Center - St. Joseph	Saint Joseph	Michigan
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri
United States	Missouri Baptist Cancer Center	Saint Louis	Missouri
United States	St. Louis University Health Sciences Center	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Veterans Affairs Medical Center - Salt Lake City	Salt Lake City	Utah
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas
United States	Veterans Affairs Medical Center - San Diego	San Diego	California
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	Veterans Affairs Medical Center - San Francisco	San Francisco	California
United States	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	Veterans Affairs Medical Center - Seattle	Seattle	Washington
United States	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana
United States	Veterans Affairs Medical Center - Shreveport	Shreveport	Louisiana
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Providence Hospital - Southfield	Southfield	Michigan
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York
United States	State University of New York - Upstate Medical University	Syracuse	New York
United States	Veterans Affairs Medical Center - Syracuse	Syracuse	New York
United States	CCOP - Northwest	Tacoma	Washington
United States	Madigan Army Medical Center	Tacoma	Washington
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Veterans Affairs Medical Center - Temple	Temple	Texas
United States	David Grant Medical Center	Travis Air Force Base	California
United States	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona
United States	Veterans Affairs Medical Center - Tucson	Tucson	Arizona
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Lombardi Cancer Center of Georgetown University Medical Center	Washington	District of Columbia
United States	MBCCOP - Howard University Cancer Center	Washington	District of Columbia
United States	Veterans Affairs Medical Center - Washington, DC	Washington	District of Columbia
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Palm Beach Cancer Institute	West Palm Beach	Florida
United States	Veterans Affairs Medical Center - White River Junction	White River Junction	Vermont
United States	CCOP - Wichita	Wichita	Kansas
United States	Veterans Affairs Medical Center - Wichita	Wichita	Kansas
United States	New Hanover Regional Medical Center	Wilmington	North Carolina
United States	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center - University Campus	Worcester	Massachusetts
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Southwest Oncology Group	Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To explore the relationship of nicotine dependence genetic markers to 12 month quit rates by way of the dopamine D2 receptor gene (DRD2).		12 months	No
Other	To assess the relationship among metabolic polymorphism genes associated with lung cancer susceptibility in smokers who are lung cancer patients.		12 months	No
Other	To examine the relationship of nicotine susceptibility markers to 1 month quit rate, gender and pharmacologic (nicotine replacement therapy and either placebo or bupropion.		12 months	No
Primary	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		12 months	No
Secondary	To assess predictors of successful cessation in male and female patients.		12 months	No
Secondary	To explore the relationship between smoking cessation and standard outcome measures.		12 months	No
Secondary	To compare the effect on emotional functioning of adding bupropion to a behavioral intervention plus nicotine replacement in this patient population.		12 months	No