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

Condition(s) targeted: Lung Cancer

Intervention: bupropion hydrochloride (Drug); nicotine (Drug); psychosocial assessment and care (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: Southwest Oncology Group

Official(s) and/or principal investigator(s):
Ellen R. Gritz, PhD, Study Chair, Affiliation: M.D. Anderson Cancer Center
Philip C. Hoffman, MD, Study Chair, Affiliation: University of Chicago
James Stevenson, MD, Study Chair, Affiliation: Presbyterian Medical Center

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.

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

Study design: Prevention, Randomized, Double-Blind, Active Control

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan 00936-5067, Puerto Rico

MBCCOP - Gulf Coast, Mobile, Alabama 36688, United States

Northeast Alabama Regional Medical Center, Anniston, Alabama 36207, United States

Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona 85724, United States

CCOP - Western Regional, Arizona, Phoenix, Arizona 85006-2726, United States

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden), Phoenix, Arizona 85012, United States

Veterans Affairs Medical Center - Tucson, Tucson, Arizona 85723, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock, Arkansas 72205, United States

CCOP - Bay Area Tumor Institute, Oakland, California 94609-3305, United States

CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California 95403, United States

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles, California 90048, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange, California 92868, United States

City of Hope Comprehensive Cancer Center, Duarte, California 91010, United States

David Grant Medical Center, Travis Air Force Base, California 94535, United States

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-1781, United States

Rebecca and John Moores UCSD Cancer Center, La Jolla, California 92093-0658, United States

UCSF Comprehensive Cancer Center, San Francisco, California 94115, United States

University of California Davis Cancer Center, Sacramento, California 95817, United States

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California 90033-0804, United States

Veterans Affairs Medical Center - San Diego, San Diego, California 92161, United States

Veterans Affairs Medical Center - San Francisco, San Francisco, California 94121, United States

Veterans Affairs Medical Center - West Los Angeles, Los Angeles, California 90073, United States

Veterans Affairs Outpatient Clinic - Martinez, Martinez, California 94553, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver, Colorado 80010, United States

Veterans Affairs Medical Center - Denver, Denver, Colorado 80220, United States

CCOP - Christiana Care Health Services, Newark, Delaware 19713, United States

Lombardi Cancer Center of Georgetown University Medical Center, Washington, District of Columbia 20007, United States

MBCCOP - Howard University Cancer Center, Washington, District of Columbia 20060, United States

Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia 20422, United States

Walter Reed Army Medical Center, Washington, District of Columbia 20307-5000, United States

Broward General Medical Center, Fort Lauderdale, Florida 33316, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida 33140, United States

Florida Hospital Cancer Institute, Orlando, Florida 32804, United States

Memorial Regional Hospital Comprehensive Cancer Center, Hollywood, Florida 33021, United States

Palm Beach Cancer Institute, West Palm Beach, Florida 33401, United States

CCOP - Atlanta Regional, Atlanta, Georgia 30342-1701, United States

MBCCOP - Hawaii, Honolulu, Hawaii 96813, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Central Illinois, Decatur, Illinois 62526, United States

Louis A. Weiss Memorial Hospital, Chicago, Illinois 60640, United States

Loyola University Medical Center, Maywood, Illinois 60153-5500, United States

MBCCOP - University of Illinois at Chicago, Chicago, Illinois 60612-7323, United States

Saint Anthony Medical Center, Rockford, Illinois 61108, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois 60612, United States

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois 60141, United States

West Suburban Center for Cancer Care, River Forest, Illinois 60305, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States

Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana 46885-5099, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States

Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa 52242-1009, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

Kansas Cancer Institute at the University of Kansas Medical Center, Kansas City, Kansas 66160-7353, United States

Veterans Affairs Medical Center - Wichita, Wichita, Kansas 67218, United States

Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky 40536-0084, United States

Baptist Hospital East - Louisville, Louisville, Kentucky 40207, United States

Veterans Affairs Medical Center - Lexington, Lexington, Kentucky 40502-2236, United States

Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana 71130-3932, United States

MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana 70112, United States

Tulane University School of Medicine, New Orleans, Louisiana 70112, United States

Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana 70112, United States

Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana 71130, United States

Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland 21201, United States

Veterans Affairs Medical Center - Baltimore, Baltimore, Maryland 21201, United States

Cancer Research Center at Boston Medical Center, Boston, Massachusetts 02118, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

University of Massachusetts Memorial Medical Center - University Campus, Worcester, Massachusetts 01655, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan 48201-1379, United States

CCOP - Beaumont, Royal Oak, Michigan 48073-6769, United States

CCOP - Grand Rapids, Grand Rapids, Michigan 49503, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan 48202, United States

Lakeland Medical Center - St. Joseph, Saint Joseph, Michigan 49085, United States

Providence Hospital - Southfield, Southfield, Michigan 48075-9975, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan 48109-0912, United States

Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan 48105, United States

Veterans Affairs Medical Center - Detroit, Detroit, Michigan 48201-1932, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States

Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota 55417, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216-4505, United States

Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi 39531-2410, United States

Veterans Affairs Medical Center - Jackson, Jackson, Mississippi 39216, United States

Barnes-Jewish Hospital, Saint Louis, Missouri 63110, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri 65807, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri 63141, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri 65203, United States

Missouri Baptist Cancer Center, Saint Louis, Missouri 63131, United States

St. Louis University Health Sciences Center, Saint Louis, Missouri 63110, United States

Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri 65201, United States

Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri 64128, United States

CCOP - Montana Cancer Consortium, Billings, Montana 59101, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198-7680, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada 89106, United States

Norris Cotton Cancer Center at Dartmouth Medical School, Lebanon, New Hampshire 03756-0002, United States

Cooper University Hospital, Camden, New Jersey 08103, United States

MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico 87131, United States

Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico 87108-5138, United States

CCOP - North Shore University Hospital, Manhasset, New York 11030, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York 13217, United States

Elmhurst Hospital Center, Elmhurst, New York 11373, United States

Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York 10032, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York 14642, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States

Mount Sinai Medical Center, NY, New York, New York 10029, United States

New York Weill Cornell Cancer Center at Cornell University, New York, New York 10021, United States

North Shore University Hospital, Manhasset, New York 11030, United States

Queens Cancer Center of Queens Hospital, Jamaica, New York 11432, United States

State University of New York - Upstate Medical University, Syracuse, New York 13210, United States

Veterans Affairs Medical Center - Albany, Albany, New York 12208, United States

Veterans Affairs Medical Center - Buffalo, Buffalo, New York 14215, United States

Veterans Affairs Medical Center - Syracuse, Syracuse, New York 13210, United States

Cape Fear Valley Health System, Fayetteville, North Carolina 28302-2000, United States

CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina 27104-4241, United States

Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina 27157-1082, United States

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States

FirstHealth Moore Regional Hospital, Pinehurst, North Carolina 28374, United States

Lenoir Memorial Hospital Cancer Center, Kinston, North Carolina 28503-1678, United States

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina 27599-7295, United States

New Hanover Regional Medical Center, Wilmington, North Carolina 28402-9025, United States

NorthEast Oncology Associates, Concord, North Carolina 28025, United States

Veterans Affairs Medical Center - Asheville, Asheville, North Carolina 28805, United States

Veterans Affairs Medical Center - Durham, Durham, North Carolina 27705, United States

Veterans Affairs Medical Center - Fargo, Fargo, North Dakota 58102, United States

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio 43210-1240, United States

CCOP - Columbus, Columbus, Ohio 43206, United States

CCOP - Dayton, Dayton, Ohio 45429, United States

Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio 45267-0501, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195-9001, United States

Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio 45220-2288, United States

Veterans Affairs Medical Center - Dayton, Dayton, Ohio 45428, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States

Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma 73104, United States

Cancer Institute at Oregon Health and Science University, Portland, Oregon 97201-3098, United States

CCOP - Columbia River Oncology Program, Portland, Oregon 97225, United States

Veterans Affairs Medical Center - Portland, Portland, Oregon 97207, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania 19096, United States

Western Pennsylvania Hospital, Pittsburgh, Pennsylvania 15224, United States

Lifespan: The Miriam Hospital, Providence, Rhode Island 02906, United States

CCOP - Greenville, Greenville, South Carolina 29615, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina 29425, United States

Veterans Affairs Medical Center - Charleston, Charleston, South Carolina 29401-5799, United States

Danville Radiation Therapy Center, Memphis, Tennessee 38104, United States

University of Tennessee Cancer Institute, Memphis, Tennessee 38103, United States

Brooke Army Medical Center, Fort Sam Houston, Texas 78234-6200, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

Harrington Cancer Center, Amarillo, Texas 79106, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas 77030-4095, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229-3900, United States

University of Texas Medical Branch, Galveston, Texas 77555-0565, United States

Veterans Affairs Medical Center - Amarillo, Amarillo, Texas 79106, United States

Veterans Affairs Medical Center - Dallas, Dallas, Texas 75216, United States

Veterans Affairs Medical Center - Houston, Houston, Texas 77030, United States

Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas 78229, United States

Veterans Affairs Medical Center - Temple, Temple, Texas 76504, United States

Huntsman Cancer Institute, Salt Lake City, Utah 84112-5550, United States

Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah 84148, United States

Green Mountain Oncology Group, Bennington, Vermont 05201, United States

Vermont Cancer Center at University of Vermont, Burlington, Vermont 05401-3498, United States

Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont 05009, United States

Martha Jefferson Hospital, Charlottesville, Virginia 22902, United States

MBCCOP - Massey Cancer Center, Richmond, Virginia 23298-0037, United States

Oncology and Hematology Associates of Southwest Virginia, Inc., Roanoke, Virginia 24014, United States

Virginia Oncology Associates - Norfolk, Norfolk, Virginia 23502, United States

CCOP - Northwest, Tacoma, Washington 98405-0986, United States

CCOP - Virginia Mason Research Center, Seattle, Washington 98101, United States

Madigan Army Medical Center, Tacoma, Washington 98431-5000, United States

Veterans Affairs Medical Center - Seattle, Seattle, Washington 98108, United States

St. Mary's Medical Center, Huntington, West Virginia 25701, United States

CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin 54449, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin 54307-3453, United States

Ministry Medical Group - Northern Region, Rhinelander, Wisconsin 54501, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 2002
Last updated: May 23, 2008