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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Ellen R. Gritz, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069256

NCT ID:

NCT00032084

Start Date:

January 2002

Completion Date:

February 2004

Related Keywords:

  • Lung Cancer
  • non-small cell lung cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
MBCCOP - HawaiiHonolulu, Hawaii  96813
University of Chicago Cancer Research CenterChicago, Illinois  60637
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Barnes-Jewish HospitalSaint Louis, Missouri  63110
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Loyola University Medical CenterMaywood, Illinois  60153
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Outpatient Clinic - MartinezMartinez, California  94553
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
CCOP - Central IllinoisSpringfield, Illinois  62526
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Tulane University School of MedicineNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - GreenvilleGreenville, South Carolina  29615
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
Green Mountain Oncology GroupRutland, Vermont  05701
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Martha Jefferson HospitalCharlottesville, Virginia  22901
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)Phoenix, Arizona  85012
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan)Little Rock, Arkansas  72205
Veterans Affairs Medical Center - West Los AngelesLos Angeles, California  90073
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)Hines, Illinois  60141
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - ShreveportShreveport, Louisiana  71130
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Providence Hospital - SouthfieldSouthfield, Michigan  48075-9975
Veterans Affairs Medical Center - BiloxiBiloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - JacksonJackson, Mississippi  39216
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - Oklahoma CityOklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - PortlandPortland, Oregon  97207
Veterans Affairs Medical Center - CharlestonCharleston, South Carolina  29401-5799
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Veterans Affairs Medical Center - Salt Lake CitySalt Lake City, Utah  84148
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Veterans Affairs Medical Center - SeattleSeattle, Washington  98108
CCOP - NorthwestTacoma, Washington  98405-0986
Madigan Army Medical CenterTacoma, Washington  98431-5048
Veterans Affairs Medical Center - New OrleansNew Orleans, Louisiana  70112
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
University of California Davis Cancer CenterSacramento, California  95817
Broward General Medical CenterFort Lauderdale, Florida  33316
Florida Hospital Cancer InstituteOrlando, Florida  32804
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer CenterHollywood, Florida  33021
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Saint Anthony Medical CenterRockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201
Lakeland Medical Center - St. JosephSaint Joseph, Michigan  49085
Veterans Affairs Medical Center - Las VegasLas Vegas, Nevada  89106
Cooper University HospitalCamden, New Jersey  08103
Elmhurst Hospital CenterElmhurst, New York  11373
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
NorthEast Oncology AssociatesConcord, North Carolina  28025
Cape Fear Valley Health SystemFayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer CenterKinston, North Carolina  28503-1678
FirstHealth Moore Regional HospitalPinehurst, North Carolina  28374
New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
Danville Radiation Therapy CenterMemphis, Tennessee  38104
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
Veterans Affairs Medical Center - AmarilloAmarillo, Texas  79106
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
St. Mary's Medical CenterHuntington, West Virginia  25701
Ministry Medical Group - Northern RegionRhinelander, Wisconsin  54501
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California  90048
Norris Cotton Cancer Center at Dartmouth Medical SchoolLebanon, New Hampshire  03756-0002
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Kansas Cancer Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7357
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Lombardi Cancer Center of Georgetown University Medical CenterWashington, District of Columbia  20007