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
Verified date | March 2013 |
Source | Southwest Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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 |
Lead Sponsor | Collaborator |
---|---|
Southwest Oncology Group | Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, National Cancer Institute (NCI) |
United States, Puerto Rico,
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 |
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