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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 Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
MBCCOP - Hawaii Honolulu, Hawaii  96813
University of Chicago Cancer Research Center Chicago, Illinois  60637
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Barnes-Jewish Hospital Saint Louis, Missouri  63110
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Loyola University Medical Center Maywood, Illinois  60153
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Huntsman Cancer Institute Salt Lake City, Utah  84112
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
Veterans Affairs Medical Center - Albany Albany, New York  12208
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
CCOP - Greenville Greenville, South Carolina  29615
Harrington Cancer Center Amarillo, Texas  79106
University of Texas Medical Branch Galveston, Texas  77555-1329
Green Mountain Oncology Group Rutland, Vermont  05701
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Martha Jefferson Hospital Charlottesville, Virginia  22901
CCOP - Western Regional, Arizona Phoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center Orange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology Program Portland, Oregon  97225
CCOP - Scott and White Hospital Temple, Texas  76508
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
North Shore University Hospital Manhasset, New York  11030
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
MBCCOP - Gulf Coast Mobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
Veterans Affairs Medical Center - West Los Angeles Los Angeles, California  90073
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Veterans Affairs Medical Center - Denver Denver, 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 - Wichita Wichita, Kansas  67218
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Providence Hospital - Southfield Southfield, Michigan  48075-9975
Veterans Affairs Medical Center - Biloxi Biloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - Oklahoma City Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Veterans Affairs Medical Center - Charleston Charleston, South Carolina  29401-5799
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - Houston Houston, Texas  77030
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Madigan Army Medical Center Tacoma, Washington  98431-5048
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
Baptist Hospital East - Louisville Louisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Fargo Fargo, North Dakota  58102
Oncology and Hematology Associates of Southwest Virginia, Inc. Roanoke, Virginia  24014
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658
University of California Davis Cancer Center Sacramento, California  95817
Broward General Medical Center Fort Lauderdale, Florida  33316
Florida Hospital Cancer Institute Orlando, Florida  32804
Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201-1595
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
University of Massachusetts Memorial Medical Center - University Campus Worcester, Massachusetts  01655
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Northeast Alabama Regional Medical Center Anniston, Alabama  36207
City of Hope Comprehensive Cancer Center Duarte, California  91010
Veterans Affairs Medical Center - San Diego San Diego, California  92161
UCSF Comprehensive Cancer Center San Francisco, California  94115
Veterans Affairs Medical Center - Washington, DC Washington, District of Columbia  20422
Memorial Regional Hospital Comprehensive Cancer Center Hollywood, Florida  33021
Louis A. Weiss Memorial Hospital Chicago, Illinois  60640
West Suburban Center for Cancer Care River Forest, Illinois  60305
Saint Anthony Medical Center Rockford, Illinois  61108
Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Baltimore Baltimore, Maryland  21201
Lakeland Medical Center - St. Joseph Saint Joseph, Michigan  49085
Veterans Affairs Medical Center - Las Vegas Las Vegas, Nevada  89106
Cooper University Hospital Camden, New Jersey  08103
Elmhurst Hospital Center Elmhurst, New York  11373
Queens Cancer Center of Queens Hospital Jamaica, New York  11432
Veterans Affairs Medical Center - Asheville Asheville, North Carolina  28805
NorthEast Oncology Associates Concord, North Carolina  28025
Cape Fear Valley Health System Fayetteville, North Carolina  28302-2000
Lenoir Memorial Hospital Cancer Center Kinston, North Carolina  28503-1678
FirstHealth Moore Regional Hospital Pinehurst, North Carolina  28374
New Hanover Regional Medical Center Wilmington, North Carolina  28402-9025
Lifespan: The Miriam Hospital Providence, Rhode Island  02906
Danville Radiation Therapy Center Memphis, Tennessee  38104
University of Tennessee Cancer Institute Memphis, Tennessee  38103
Veterans Affairs Medical Center - Amarillo Amarillo, Texas  79106
Veterans Affairs Medical Center - Dallas Dallas, Texas  75216
Virginia Oncology Associates - Norfolk Norfolk, Virginia  23502
St. Mary's Medical Center Huntington, West Virginia  25701
Ministry Medical Group - Northern Region Rhinelander, Wisconsin  54501
CCOP - Beaumont Royal Oak, Michigan  48073-6769
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Cancer Research Center at Boston Medical Center Boston, Massachusetts  02118
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Herbert Irving Comprehensive Cancer Center at Columbia University New York, New York  10032
Cancer Institute at Oregon Health and Science University Portland, Oregon  97201-3098
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Vermont Cancer Center at University of Vermont Burlington, Vermont  05405-0075
MBCCOP - Howard University Cancer Center Washington, District of Columbia  20060
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center Los Angeles, California  90048
Norris Cotton Cancer Center at Dartmouth Medical School Lebanon, New Hampshire  03756-0002
Missouri Baptist Cancer Center St. Louis, Missouri  63131
Kansas Cancer Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7357
Palm Beach Cancer Institute West Palm Beach, Florida  33401
Lombardi Cancer Center of Georgetown University Medical Center Washington, District of Columbia  20007