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

NCT00032084 | Terminated Phase 3 DMC

• 5 other identifiers: CDR0000069256SWOG-S0002CALGB-79807ECOG-S0002NCI-P02-0215
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 176

Brief 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.

Conditions

Lung Cancer

Keywords

non-small cell lung cancer; stage I non-small cell lung cancer; stage II non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• To assess predictors of successful cessation in male and female patients.

  12 months

• To explore the relationship between smoking cessation and standard outcome measures.

  12 months

• To compare the effect on emotional functioning of adding bupropion to a behavioral intervention plus nicotine replacement in this patient population.

  12 months

Other Outcomes (3)

• 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

• To assess the relationship among metabolic polymorphism genes associated with lung cancer susceptibility in smokers who are lung cancer patients.

  12 months

• 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

Study Arms (2)

Behavioral Intervention + Placebo

PLACEBO COMPARATOR

Smoking cessation intervention , nicotine replacement, psychosocial assessment and care, and placebo.

Behavioral: smoking cessation intervention; Drug: nicotine; Procedure: psychosocial assessment and care

Behavioral Intervention + Bupropion

ACTIVE COMPARATOR

Smoking cessation intervention, nicotine replacement, psychosocial assessment and care, and bupropion hydrochloride .

Behavioral: smoking cessation intervention; Drug: bupropion hydrochloride; Drug: nicotine; Procedure: psychosocial assessment and care

Interventions

smoking cessation intervention BEHAVIORAL

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

Behavioral Intervention + Bupropion; Behavioral Intervention + Placebo

bupropion hydrochloride DRUG

150 mg/day on Days 1-3, 300 mg/day on Day 4-77

Also known as: Zyban

Behavioral Intervention + Bupropion

nicotine DRUG

21 mg patch/day for Weeks 2-7; 14 mg patch/day for Weeks 8-9; 7 mg patch/day for Weeks 10-11.

Also known as: Nicoderm CQ

Behavioral Intervention + Bupropion; Behavioral Intervention + Placebo

psychosocial assessment and care PROCEDURE

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).

Behavioral Intervention + Bupropion; Behavioral Intervention + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator
• Cancer and Leukemia Group B: collaborator
• Eastern Cooperative Oncology Group: collaborator

Study Sites (176)

Northeast Alabama Regional Medical Center

Anniston, Alabama, 36207, United States

Location

MBCCOP - Gulf Coast

Mobile, Alabama, 36688, United States

Location

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)

Phoenix, Arizona, 85012, United States

Location

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, 85723, United States

Location

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Veterans Affairs Medical Center - Little Rock (McClellan)

Little Rock, Arkansas, 72205, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Veterans Affairs Medical Center - West Los Angeles

Los Angeles, California, 90073, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Veterans Affairs Outpatient Clinic - Martinez

Martinez, California, 94553, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609-3305, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

Orange, California, 92868, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Veterans Affairs Medical Center - San Diego

San Diego, California, 92161, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Veterans Affairs Medical Center - San Francisco

San Francisco, California, 94121, United States

Location

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, 95403, United States

Location

David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, 80010, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Lombardi Cancer Center of Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MBCCOP - Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

Veterans Affairs Medical Center - Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Memorial Regional Hospital Comprehensive Cancer Center

Hollywood, Florida, 33021, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Palm Beach Cancer Institute

West Palm Beach, Florida, 33401, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, 60612-7323, United States

Location

Veterans Affairs Medical Center - Chicago (Westside Hospital)

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Louis A. Weiss Memorial Hospital

Chicago, Illinois, 60640, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62526, United States

Location

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

Hines, Illinois, 60141, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153-5500, United States

Location

West Suburban Center for Cancer Care

River Forest, Illinois, 60305, United States

Location

Saint Anthony Medical Center

Rockford, Illinois, 61108, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Fort Wayne Medical Oncology and Hematology, Incorporated

Fort Wayne, Indiana, 46885-5099, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Kansas Cancer Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160-7353, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Veterans Affairs Medical Center - Wichita

Wichita, Kansas, 67218, United States

Location

Veterans Affairs Medical Center - Lexington

Lexington, Kentucky, 40502-2236, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

Baptist Hospital East - Louisville

Louisville, Kentucky, 40207, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Veterans Affairs Medical Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Veterans Affairs Medical Center - Shreveport

Shreveport, Louisiana, 71130, United States

Location

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Veterans Affairs Medical Center - Baltimore

Baltimore, Maryland, 21201, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Massachusetts Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

Veterans Affairs Medical Center - Ann Arbor

Ann Arbor, Michigan, 48105, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0912, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Veterans Affairs Medical Center - Detroit

Detroit, Michigan, 48201-1932, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Beaumont

Royal Oak, Michigan, 48073-6769, United States

Location

Lakeland Medical Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Providence Hospital - Southfield

Southfield, Michigan, 48075-9975, United States

Location

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Veterans Affairs Medical Center - Biloxi

Biloxi, Mississippi, 39531-2410, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Veterans Affairs Medical Center - Jackson

Jackson, Mississippi, 39216, United States

Location

Veterans Affairs Medical Center - Columbia (Truman Memorial)

Columbia, Missouri, 65201, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Veterans Affairs Medical Center - Kansas City

Kansas City, Missouri, 64128, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Veterans Affairs Medical Center - Las Vegas

Las Vegas, Nevada, 89106, United States

Location

Norris Cotton Cancer Center at Dartmouth Medical School

Lebanon, New Hampshire, 03756-0002, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Veterans Affairs Medical Center - Albuquerque

Albuquerque, New Mexico, 87108-5138, United States

Location

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, 87131, United States

Location

Veterans Affairs Medical Center - Albany

Albany, New York, 12208, United States

Location

Veterans Affairs Medical Center - Buffalo

Buffalo, New York, 14215, United States

Location

Elmhurst Hospital Center

Elmhurst, New York, 11373, United States

Location

Queens Cancer Center of Queens Hospital

Jamaica, New York, 11432, United States

Location

CCOP - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Mount Sinai Medical Center, NY

New York, New York, 10029, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, 13210, United States

Location

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

Syracuse, New York, 13217, United States

Location

Veterans Affairs Medical Center - Asheville

Asheville, North Carolina, 28805, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

NorthEast Oncology Associates

Concord, North Carolina, 28025, United States

Location

Veterans Affairs Medical Center - Durham

Durham, North Carolina, 27705, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Cape Fear Valley Health System

Fayetteville, North Carolina, 28302-2000, United States

Location

Lenoir Memorial Hospital Cancer Center

Kinston, North Carolina, 28503-1678, United States

Location

FirstHealth Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States

Location

New Hanover Regional Medical Center

Wilmington, North Carolina, 28402-9025, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Veterans Affairs Medical Center - Fargo

Fargo, North Dakota, 58102, United States

Location

Veterans Affairs Medical Center - Cincinnati

Cincinnati, Ohio, 45220-2288, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0501, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195-9001, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Veterans Affairs Medical Center - Oklahoma City

Oklahoma City, Oklahoma, 73104, United States

Location

Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97201-3098, United States

Location

Veterans Affairs Medical Center - Portland

Portland, Oregon, 97207, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

Lifespan: The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Veterans Affairs Medical Center - Charleston

Charleston, South Carolina, 29401-5799, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

University of Tennessee Cancer Institute

Memphis, Tennessee, 38103, United States

Location

Danville Radiation Therapy Center

Memphis, Tennessee, 38104, United States

Location

Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Veterans Affairs Medical Center - Amarillo

Amarillo, Texas, 79106, United States

Location

Veterans Affairs Medical Center - Dallas

Dallas, Texas, 75216, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234-6200, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0565, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4095, United States

Location

Veterans Affairs Medical Center - Houston

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

Veterans Affairs Medical Center - San Antonio (Murphy)

San Antonio, Texas, 78229, United States

Location

Veterans Affairs Medical Center - Temple

Temple, Texas, 76504, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112-5550, United States

Location

Veterans Affairs Medical Center - Salt Lake City

Salt Lake City, Utah, 84148, United States

Location

Green Mountain Oncology Group

Bennington, Vermont, 05201, United States

Location

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05401-3498, United States

Location

Veterans Affairs Medical Center - White River Junction

White River Junction, Vermont, 05009, United States

Location

Martha Jefferson Hospital

Charlottesville, Virginia, 22902, United States

Location

Virginia Oncology Associates - Norfolk

Norfolk, Virginia, 23502, United States

Location

MBCCOP - Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, 24014, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Veterans Affairs Medical Center - Seattle

Seattle, Washington, 98108, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405-0986, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431-5000, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25701, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54307-3453, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Ministry Medical Group - Northern Region

Rhinelander, Wisconsin, 54501, United States

Location

University of Puerto Rico School of Medicine Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Bupropion; Nicotine; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2002
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: March 11, 2013

Record last verified: 2013-03

Locations

PR (1); US (175)