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S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer

3. juli 2018 oppdatert av: Southwest Oncology Group

Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether cisplatin combined with irinotecan is more effective than cisplatin combined with etoposide in treating extensive-stage small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin combined with either irinotecan or etoposide in treating patients who have extensive-stage small cell lung cancer.

Studieoversikt

Status

Fullført

Forhold

Lungekreft

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

Compare the survival of patients with extensive stage small cell lung cancer treated with cisplatin and irinotecan vs cisplatin and etoposide.
Compare the objective response rate and progression-free survival of patients treated with these regimens.
Compare the toxic effects of these regimens in these patients.
Determine the association between UGT1A1 polymorphisms and irinotecan-associated toxic effects in these patients.
Determine the association between ERCC-1 and XRCC-1 polymorphisms and non-response of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of metastatic sites (single vs multiple), lactic dehydrogenase (no greater than upper limit of normal (ULN) vs greater than ULN), and weight loss in the past 6 months (5% or less vs more than 5%). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive irinotecan IV over 90 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 4 weeks.
Arm II: Patients receive etoposide IV over 30-60 minutes on days 1-3 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 3 weeks.

Treatment in both arms continues for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 620 patients (310 per treatment arm) will be accrued for this study within 4 years.

Studietype

Intervensjonell

Registrering (Faktiske)

671

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Canada
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre at Pasqua Hospital
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Saskatoon Cancer Centre at the University of Saskatchewan
Forente stater
- Alabama
  - Anniston, Alabama, Forente stater, 36202
    - Northeast Alabama Regional Medical Center
  - Huntsville, Alabama, Forente stater, 35801
    - Huntsville Hospital
  - Mobile, Alabama, Forente stater, 36652-2144
    - Mobile Infirmary Medical Center
  - Opelika, Alabama, Forente stater, 36801-5452
    - East Alabama Medical Center
- Alaska
  - Anchorage, Alaska, Forente stater, 99508
    - Alaska Regional Hospital Cancer Center
- Arizona
  - Scottsdale, Arizona, Forente stater, 85259-5499
    - Mayo Clinic Scottsdale
  - Tucson, Arizona, Forente stater, 85724-5024
    - Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas
  - Fort Smith, Arkansas, Forente stater, 72903
    - Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
  - Little Rock, Arkansas, Forente stater, 72205
    - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- California
  - Burbank, California, Forente stater, 91505
    - Providence Saint Joseph Medical Center - Burbank
  - Concord, California, Forente stater, 94524-4110
    - Cancer Care Center at John Muir Health - Concord Campus
  - Fremont, California, Forente stater, 94538
    - Washington Township Hospital
  - Fresno, California, Forente stater, 93720
    - California Cancer Center - Woodward Park Office
  - Los Angeles, California, Forente stater, 90089-9181
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Palm Springs, California, Forente stater, 92262
    - Desert Regional Medical Center Comprehensive Cancer Center
  - Redding, California, Forente stater, 96001
    - Shasta Regional Medical Center
  - Roseville, California, Forente stater, 95661
    - Sutter Cancer Center at Roseville Medical Center
  - Sacramento, California, Forente stater, 95816
    - Sutter Cancer Center
  - Sacramento, California, Forente stater, 95817
    - University of California Davis Cancer Center
  - Santa Rosa, California, Forente stater, 95405
    - CCOP - Santa Rosa Memorial Hospital
  - Walnut Creek, California, Forente stater, 94598
    - John Muir/Mt. Diablo Comprehensive Cancer Center
- Colorado
  - Colorado Springs, Colorado, Forente stater, 80909
    - Memorial Hospital
- Connecticut
  - Norwich, Connecticut, Forente stater, 06360
    - Eastern Connecticut Hematology and Oncology Associates
- Florida
  - Daytona Beach, Florida, Forente stater, 32115
    - Halifax Medical Center - Daytona Beach
  - Fort Lauderdale, Florida, Forente stater, 33316
    - Broward General Medical Center Cancer Center
  - Pensacola, Florida, Forente stater, 32514
    - West Florida Cancer Institute at West Florida Hospital - Pensacola
- Georgia
  - Atlanta, Georgia, Forente stater, 30309
    - Piedmont Hospital
  - Atlanta, Georgia, Forente stater, 30342-1611
    - Northside Hospital Cancer Center
  - Atlanta, Georgia, Forente stater, 30342-1701
    - Saint Joseph's Hospital of Atlanta
  - Atlanta, Georgia, Forente stater, 30342
    - CCOP - Atlanta Regional
  - Augusta, Georgia, Forente stater, 30901
    - Augusta Oncology Associates - Walton Way
  - Austell, Georgia, Forente stater, 30106
    - WellStar Cobb Hospital
  - Decatur, Georgia, Forente stater, 30033
    - Charles B. Eberhart Cancer Center at DeKalb Medical Center
  - Lawrenceville, Georgia, Forente stater, 30045
    - Gwinnett Medical Center
  - Marietta, Georgia, Forente stater, 30060
    - Kennestone Cancer Center at Wellstar Kennestone Hospital
  - Riverdale, Georgia, Forente stater, 30274-2600
    - Southern Regional Medical Center
  - Savannah, Georgia, Forente stater, 31403-3089
    - Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  - Valdosta, Georgia, Forente stater, 31603
    - Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Hawaii
  - Honolulu, Hawaii, Forente stater, 96859
    - Tripler Army Medical Center
- Idaho
  - Idaho Falls, Idaho, Forente stater, 83404
    - Hematology Oncology Associates of Eastern Idaho
- Illinois
  - Alton, Illinois, Forente stater, 62002
    - Saint Anthony's Hospital at Saint Anthony's Health Center
  - Aurora, Illinois, Forente stater, 60507
    - Rush-Copley Cancer Care Center
  - Decatur, Illinois, Forente stater, 62526
    - Decatur Memorial Hospital Cancer Care Institute
  - Elmhurst, Illinois, Forente stater, 60126
    - Elmhurst Memorial Hospital
  - Hines, Illinois, Forente stater, 60141
    - Veterans Affairs Medical Center - Hines
  - Joliet, Illinois, Forente stater, 60435
    - Joliet Oncology-Hematology Associates, Limited - West
  - La Grange, Illinois, Forente stater, 60525
    - La Grange Memorial Hospital
  - Maywood, Illinois, Forente stater, 60153
    - Cardinal Bernardin Cancer Center at Loyola University Medical Center
  - Moline, Illinois, Forente stater, 61265
  - Moline, Illinois, Forente stater, 61265
    - Trinity Medical Center - East
  - Mount Vernon, Illinois, Forente stater, 62864
    - Good Samaritan Regional Health Center
  - River Forest, Illinois, Forente stater, 60305
    - West Suburban Center for Cancer Care
  - Rockford, Illinois, Forente stater, 61104-2315
    - Swedish-American Regional Cancer Center
  - Springfield, Illinois, Forente stater, 62781-0001
    - Regional Cancer Center at Memorial Medical Center
  - Urbana, Illinois, Forente stater, 61801
    - Carle Cancer Center at Carle Foundation Hospital
  - Urbana, Illinois, Forente stater, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Beech Grove, Indiana, Forente stater, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Elkhart, Indiana, Forente stater, 46515
    - Elkhart General Hospital
  - Kokomo, Indiana, Forente stater, 46904
    - Howard Community Hospital at Howard Regional Health System
  - La Porte, Indiana, Forente stater, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Michigan City, Indiana, Forente stater, 46360
    - Saint Anthony Memorial Health Centers
  - Richmond, Indiana, Forente stater, 47374
    - Reid Hospital & Health Care Services, Incorporated
  - South Bend, Indiana, Forente stater, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, Forente stater, 46601
    - CCOP - Northern Indiana CR Consortium
  - South Bend, Indiana, Forente stater, 46617
    - Saint Joseph Regional Medical Center
- Iowa
  - Bettendorf, Iowa, Forente stater, 52722
  - Bettendorf, Iowa, Forente stater, 52722
    - Hematology Oncology Associates of the Quad Cities
  - Cedar Rapids, Iowa, Forente stater, 52402
    - St. Luke's Hospital
  - Cedar Rapids, Iowa, Forente stater, 52403
    - Cedar Rapids Oncology Associates
  - Cedar Rapids, Iowa, Forente stater, 52403
    - Mercy Regional Cancer Center at Mercy Medical Center
  - Council Bluffs, Iowa, Forente stater, 51503
    - Heartland Oncology & Hematology
  - Davenport, Iowa, Forente stater, 52804
    - Genesis Medical Center - West Campus
  - Davenport, Iowa, Forente stater, 52803
    - Genesis Regional Cancer Center at Genesis Medical Center
  - Des Moines, Iowa, Forente stater, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, Forente stater, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, Forente stater, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, Forente stater, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, Forente stater, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, Forente stater, 50307
    - Mercy Capitol Hospital
  - Des Moines, Iowa, Forente stater, 50316-2301
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Mason City, Iowa, Forente stater, 50401
    - Mercy Cancer Center at Mercy Medical Center - North Iowa
  - Ottumwa, Iowa, Forente stater, 52501
    - McCreery Cancer Center at Ottumwa Regional
  - Sioux City, Iowa, Forente stater, 51101
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, Forente stater, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, Forente stater, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, Forente stater, 51104
    - Mercy Medical Center - Sioux City
  - Waterloo, Iowa, Forente stater, 50702
    - Covenant Cancer Treatment Center
  - Waterloo, Iowa, Forente stater, 50702
    - Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
- Kansas
  - Chanute, Kansas, Forente stater, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, Forente stater, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, Forente stater, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Kansas City, Kansas, Forente stater, 64128
    - Veterans Affairs Medical Center - Kansas City
  - Kingman, Kansas, Forente stater, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Liberal, Kansas, Forente stater, 67901
    - Southwest Medical Center
  - Newton, Kansas, Forente stater, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, Forente stater, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, Forente stater, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, Forente stater, 67042
    - Cancer Center of Kansas, PA - Salina
  - Salina, Kansas, Forente stater, 67401
    - Tammy Walker Cancer Center at Salina Regional Health Center
  - Topeka, Kansas, Forente stater, 66604
    - Stormont-Vail Cancer Center
  - Wellington, Kansas, Forente stater, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, Forente stater, 67203
    - Associates in Womens Health, PA - North Review
  - Wichita, Kansas, Forente stater, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, Forente stater, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, Forente stater, 67214
    - CCOP - Wichita
  - Wichita, Kansas, Forente stater, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Winfield, Kansas, Forente stater, 67156
    - Cancer Center of Kansas, PA - Winfield
- Kentucky
  - Madisonville, Kentucky, Forente stater, 42431
    - Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
- Louisiana
  - Alexandria, Louisiana, Forente stater, 71315-3198
    - Tulane Cancer Center
  - Monroe, Louisiana, Forente stater, 71210
    - Louisiana State University Health Sciences Center - Monroe
  - Shreveport, Louisiana, Forente stater, 71130-3932
    - Feist-Weiller Cancer Center at Louisiana State University Health Sciences
  - Shreveport, Louisiana, Forente stater, 71101
    - Veterans Affairs Medical Center - Shreveport
  - Shreveport, Louisiana, Forente stater, 71101
    - Christus Schumpert Cancer Treatment Center
- Maine
  - Bangor, Maine, Forente stater, 04401
    - CancerCare of Maine at Eastern Maine Medial Center
  - Waterville, Maine, Forente stater, 04901
    - MaineGeneral Medical Center - Waterville Campus
- Massachusetts
  - Attleboro, Massachusetts, Forente stater, 02703
    - Sturdy Memorial Hospital
  - Boston, Massachusetts, Forente stater, 02118
    - Cancer Research Center at Boston Medical Center
  - Gloucester, Massachusetts, Forente stater, 01930
    - Addison Gilbert Hospital
  - Worcester, Massachusetts, Forente stater, 01655
    - UMASS Memorial Cancer Center - University Campus
- Michigan
  - Adrian, Michigan, Forente stater, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Ann Arbor, Michigan, Forente stater, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, Forente stater, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Battle Creek, Michigan, Forente stater, 49017
    - Battle Creek Health System Cancer Care Center
  - Big Rapids, Michigan, Forente stater, 49307
    - Mecosta County Medical Center
  - Detroit, Michigan, Forente stater, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
  - Escanaba, Michigan, Forente stater, 49431
    - Green Bay Oncology, Limited - Escanaba
  - Flint, Michigan, Forente stater, 48503
    - Hurley Medical Center
  - Flint, Michigan, Forente stater, 48503
    - Genesys Hurley Cancer Institute
  - Grand Rapids, Michigan, Forente stater, 49503
    - CCOP - Grand Rapids
  - Grand Rapids, Michigan, Forente stater, 49503
    - Lacks Cancer Center at Saint Mary's Health Care
  - Grand Rapids, Michigan, Forente stater, 49506
    - Metro Health Hospital
  - Grand Rapids, Michigan, Forente stater, 49503
    - Spectrum Health Hospital - Butterworth Campus
  - Grosse Pointe Woods, Michigan, Forente stater, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Holland, Michigan, Forente stater, 49423
    - Holland Community Hospital
  - Iron Mountain, Michigan, Forente stater, 49801
    - Green Bay Oncology, Limited - Iron Mountain
  - Jackson, Michigan, Forente stater, 49201
    - Foote Hospital
  - Kalamazoo, Michigan, Forente stater, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, Forente stater, 49001
    - Borgess Medical Center
  - Kalamazoo, Michigan, Forente stater, 49007-3731
    - West Michigan Cancer Center
  - Lansing, Michigan, Forente stater, 48909
    - Sparrow Regional Cancer Center
  - Marquette, Michigan, Forente stater, 49855
    - Upper Michigan Cancer Center at Marquette General Hospital
  - Midland, Michigan, Forente stater, 48670
    - MidMichigan Medical Center - Midland
  - Monroe, Michigan, Forente stater, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, Forente stater, 48162
    - Mercy Memorial Hospital System
  - Mount Clemens, Michigan, Forente stater, 48043
    - Ted B. Wahby Cancer Center at Mount Clemens General Hospital
  - Muskegon, Michigan, Forente stater, 49442
    - Hackley Hospital
  - Petoskey, Michigan, Forente stater, 49770
    - Northern Michigan Hospital
  - Port Huron, Michigan, Forente stater, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Saginaw, Michigan, Forente stater, 48601
    - Seton Cancer Institute - Saginaw
  - Saint Joseph, Michigan, Forente stater, 49085
    - Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
  - Traverse City, Michigan, Forente stater, 49684
    - Munson Medical Center
  - Warren, Michigan, Forente stater, 48093
    - St. John Macomb Hospital
- Minnesota
  - Alexandria, Minnesota, Forente stater, 56308
  - Bemidji, Minnesota, Forente stater, 56601
    - MeritCare Clinic - Bemidji
  - Burnsville, Minnesota, Forente stater, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, Forente stater, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Duluth, Minnesota, Forente stater, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, Forente stater, 55805
    - St. Mary's - Duluth Clinic Cancer Center
  - Duluth, Minnesota, Forente stater, 55805
    - Miller-Dwan Medical Center
  - Duluth, Minnesota, Forente stater, 55805
    - Cancer Care Center at St. Luke's Hospital
  - Edina, Minnesota, Forente stater, 55435
    - Fairview Southdale Hospital
  - Fergus Falls, Minnesota, Forente stater, 56537
  - Fridley, Minnesota, Forente stater, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, Forente stater, 55350
    - Hutchinson Area Health Care
  - Litchfield, Minnesota, Forente stater, 55355
    - Meeker County Memorial Hospital
  - Mankato, Minnesota, Forente stater, 56002
    - Immanuel St. Joseph's Clinic
  - Maplewood, Minnesota, Forente stater, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Maplewood, Minnesota, Forente stater, 55109
    - Minnesota Oncology Hematology, PA at Maplewood Cancer Center
  - Minneapolis, Minnesota, Forente stater, 55415
    - Hennepin County Medical Center - Minneapolis
  - Minneapolis, Minnesota, Forente stater, 55407
    - Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
  - Montevideo, Minnesota, Forente stater, 56265
    - Chippewa County - Montevideo Hospital
  - Robbinsdale, Minnesota, Forente stater, 55422-2900
    - Hubert H. Humphrey Cancer Center at North Memorial Medical Center
  - Rochester, Minnesota, Forente stater, 55905
    - Mayo Clinic Cancer Center
  - Saint Cloud, Minnesota, Forente stater, 56303
    - CentraCare Clinic - River Campus
  - Saint Cloud, Minnesota, Forente stater, 56303
    - Coborn Cancer Center
  - Saint Louis Park, Minnesota, Forente stater, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, Forente stater, 55416
    - Park Nicollet Health Services
  - Saint Paul, Minnesota, Forente stater, 55102
    - St. Joseph's Hospital
  - Saint Paul, Minnesota, Forente stater, 55102
    - United Hospital
  - Saint Paul, Minnesota, Forente stater, 55101
    - Regions Hospital Cancer Care Center
  - Shakopee, Minnesota, Forente stater, 55379
    - Saint Francis Cancer Center
  - Waconia, Minnesota, Forente stater, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, Forente stater, 56201
    - Willmar Cancer Center at Rice Memorial Hospital
  - Woodbury, Minnesota, Forente stater, 55125
    - Woodwinds Health Campus
  - Woodbury, Minnesota, Forente stater, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
- Mississippi
  - Jackson, Mississippi, Forente stater, 39216
    - University of Mississippi Medical Center
- Missouri
  - Cape Girardeau, Missouri, Forente stater, 63701
    - Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
  - Cape Girardeau, Missouri, Forente stater, 63701
    - Saint Francis Medical Center
  - Columbia, Missouri, Forente stater, 65201
    - Veterans Affairs Medical Center - Columbia (Truman Memorial)
  - Columbia, Missouri, Forente stater, 65203
    - Ellis Fischel Cancer Center at University of Missouri - Columbia
  - Jefferson City, Missouri, Forente stater, 65101
    - Capital Region Cancer Center
  - Joplin, Missouri, Forente stater, 64804
    - Freeman Cancer Institute at Freeman Health System
  - Kansas City, Missouri, Forente stater, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, Forente stater, 63131
    - Missouri Baptist Cancer Center
  - Saint Louis, Missouri, Forente stater, 63141
    - CCOP - St. Louis-Cape Girardeau
  - Saint Louis, Missouri, Forente stater, 63141
    - David C. Pratt Cancer Center at St. John's Mercy
  - Saint Louis, Missouri, Forente stater, 63141
    - Arch Medical Services, Incorporated at Center for Cancer Care Research
  - Springfield, Missouri, Forente stater, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, Forente stater, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, Forente stater, 65807
    - Hulston Cancer Center at Cox Medical Center South
- Montana
  - Billings, Montana, Forente stater, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, Forente stater, 59101
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Billings, Montana, Forente stater, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, Forente stater, 59101
    - St. Vincent Healthcare
  - Billings, Montana, Forente stater, 59107-5100
    - Billings Clinic Cancer Center
  - Billings, Montana, Forente stater, 59107-7000
    - Deaconess Billings Clinic - Downtown
  - Bozeman, Montana, Forente stater, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, Forente stater, 59701
    - St. James Community Hospital
  - Great Falls, Montana, Forente stater, 59405
    - Great Falls Clinic
  - Great Falls, Montana, Forente stater, 59405
  - Great Falls, Montana, Forente stater, 59405
    - Big Sky Oncology
  - Great Falls, Montana, Forente stater, 59405
    - Sletten Regional Cancer Institute at Benefis Healthcare
  - Helena, Montana, Forente stater, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, Forente stater, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, Forente stater, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, Forente stater, 59901
    - Kalispell Medical Oncology
  - Missoula, Montana, Forente stater, 59801
    - Community Medical Center
  - Missoula, Montana, Forente stater, 59804
    - Guardian Oncology and Center for Wellness
  - Missoula, Montana, Forente stater, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, Forente stater, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Kearney, Nebraska, Forente stater, 68848-1990
    - Good Samaritan Cancer Center at Good Samaritan Hospital
  - Lincoln, Nebraska, Forente stater, 68510
    - Cancer Resource Center - Lincoln
  - Omaha, Nebraska, Forente stater, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, Forente stater, 68122
    - Immanuel Medical Center
  - Omaha, Nebraska, Forente stater, 68124
    - Alegant Health Cancer Center at Bergan Mercy Medical Center
  - Omaha, Nebraska, Forente stater, 68131-2197
    - Creighton University Medical Center
  - Omaha, Nebraska, Forente stater, 68114
    - Methodist Cancer Center at Methodist Hospital - Omaha
- Nevada
  - Las Vegas, Nevada, Forente stater, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, Forente stater, 89106
    - CCOP - Nevada Cancer Research Foundation
- New Jersey
  - Flemington, New Jersey, Forente stater, 08822
    - Hunterdon Regional Cancer Center at Hunterdon Medical Center
  - Morristown, New Jersey, Forente stater, 07962
    - Carol G. Simon Cancer Center at Morristown Memorial Hospital
  - Neptune, New Jersey, Forente stater, 07754-0397
    - Jersey Shore Cancer Center at Jersey Shore University Medical Center
  - Summit, New Jersey, Forente stater, 07902
    - Overlook Hospital
- New York
  - Bronx, New York, Forente stater, 10461
    - Albert Einstein Cancer Center at Albert Einstein College of Medicine
  - Buffalo, New York, Forente stater, 14215
    - Veterans Affairs Medical Center - Buffalo
  - Clifton Springs, New York, Forente stater, 14432
    - Finger Lakes Hematology and Oncology
  - Glens Falls, New York, Forente stater, 12801
    - Adirondack Cancer Care - Glens Falls
  - Manhasset, New York, Forente stater, 11030
    - CCOP - North Shore University Hospital
  - Manhasset, New York, Forente stater, 11030
    - Don Monti Comprehensive Cancer Center at North Shore University Hospital
  - Middletown, New York, Forente stater, 10940-4199
    - Tucker Center for Cancer Care at Orange Regional Medical Center
  - Mineola, New York, Forente stater, 11501
    - Winthrop University Hospital
  - New Hyde Park, New York, Forente stater, 11042
    - Long Island Jewish Medical Center
  - Rochester, New York, Forente stater, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
  - Rochester, New York, Forente stater, 14623
    - Interlakes Oncology/Hematology PC
  - Syracuse, New York, Forente stater, 13210
    - SUNY Upstate Medical University Hospital
- North Carolina
  - Goldsboro, North Carolina, Forente stater, 27534
    - Wayne Memorial Hospital, Incorporated
  - Kinston, North Carolina, Forente stater, 28501
    - Lenoir Memorial Cancer Center
  - Rutherfordton, North Carolina, Forente stater, 28139
    - Rutherford Hospital
  - Wilmington, North Carolina, Forente stater, 28401
    - Zimmer Cancer Center at New Hanover Regional Medical Center
- North Dakota
  - Bismarck, North Dakota, Forente stater, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, Forente stater, 58501
    - Medcenter One Hospital Cancer Care Center
  - Bismarck, North Dakota, Forente stater, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, Forente stater, 58502
    - St. Alexius Medical Center Cancer Center
  - Fargo, North Dakota, Forente stater, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, Forente stater, 58122
    - MeritCare Broadway
  - Fargo, North Dakota, Forente stater, 58103
    - Dakota Cancer Institute at Dakota Clinic - South University
- Ohio
  - Akron, Ohio, Forente stater, 44307
    - McDowell Cancer Center at Akron General Medical Center
  - Bowling Green, Ohio, Forente stater, 43402
    - Wood County Oncology Center
  - Canton, Ohio, Forente stater, 44708
    - Mercy Cancer Center at Mercy Medical Center
  - Chillicothe, Ohio, Forente stater, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, Forente stater, 45267
    - Charles M. Barrett Cancer Center at University Hospital
  - Cleveland, Ohio, Forente stater, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, Forente stater, 44109
    - MetroHealth's Cancer Care Center at MetroHealth Medical Center
  - Columbus, Ohio, Forente stater, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, Forente stater, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, Forente stater, 43215
    - CCOP - Columbus
  - Columbus, Ohio, Forente stater, 43228
    - Doctors Hospital at Ohio Health
  - Columbus, Ohio, Forente stater, 43215
    - Grant Riverside Cancer Services
  - Dayton, Ohio, Forente stater, 45428
    - Veterans Affairs Medical Center - Dayton
  - Dayton, Ohio, Forente stater, 45405
    - Grandview Hospital
  - Dayton, Ohio, Forente stater, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, Forente stater, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, Forente stater, 45429
    - CCOP - Dayton
  - Delaware, Ohio, Forente stater, 43015
    - Grady Memorial Hospital
  - Findlay, Ohio, Forente stater, 45840
    - Blanchard Valley Medical Associates
  - Fremont, Ohio, Forente stater, 43420
    - Fremont Memorial Hospital
  - Independence, Ohio, Forente stater, 44131
    - Community Oncology Group at Cleveland Clinic Cancer Center
  - Kenton, Ohio, Forente stater, 43326
    - Kenton Oncology, Incorporated
  - Kettering, Ohio, Forente stater, 45429
    - Charles F. Kettering Memorial Hospital
  - Lancaster, Ohio, Forente stater, 43130
    - Fairfield Medical Center
  - Lima, Ohio, Forente stater, 45804
    - Lima Memorial Hospital
  - Lima, Ohio, Forente stater, 45801
    - St. Rita's Medical Center
  - Mansfield, Ohio, Forente stater, 44903
    - MedCentral - Mansfield Hospital
  - Marietta, Ohio, Forente stater, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Maumee, Ohio, Forente stater, 43537
    - St. Luke's Hospital
  - Maumee, Ohio, Forente stater, 43623
    - Northwest Ohio Oncology Center
  - Middletown, Ohio, Forente stater, 45044
    - Middletown Regional Hospital
  - Newark, Ohio, Forente stater, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Oregon, Ohio, Forente stater, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, Forente stater, 43616
    - Toledo Clinic - Oregon
  - Sandusky, Ohio, Forente stater, 44870
    - Firelands Regional Medical Center
  - Sandusky, Ohio, Forente stater, 44870
    - North Coast Cancer Care, Incorporated
  - Springfield, Ohio, Forente stater, 45505
    - Community Hospital of Springfield and Clark County
  - Springfield, Ohio, Forente stater, 45504
    - Mercy Medical Center
  - Sylvania, Ohio, Forente stater, 43560
    - Flower Hospital Cancer Center
  - Toledo, Ohio, Forente stater, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, Forente stater, 43606
    - Toledo Hospital
  - Toledo, Ohio, Forente stater, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, Forente stater, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, Forente stater, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Troy, Ohio, Forente stater, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, Forente stater, 43567
    - Fulton County Health Center
  - Westerville, Ohio, Forente stater, 43081
    - Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
  - Wooster, Ohio, Forente stater, 44691
    - Cleveland Clinic - Wooster
  - Xenia, Ohio, Forente stater, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  - Youngstown, Ohio, Forente stater, 44501
    - Tod Children's Hospital - Forum Health
  - Zanesville, Ohio, Forente stater, 43701
    - Genesis - Good Samaritan Hospital
- Oregon
  - Klamath Falls, Oregon, Forente stater, 97601
    - Merle West Medical Center Cancer Treatment Center
  - Portland, Oregon, Forente stater, 97207
    - Veterans Affairs Medical Center - Portland
  - Portland, Oregon, Forente stater, 97239-3098
    - Oregon Health & Science University Cancer Institute
  - Portland, Oregon, Forente stater, 97232
    - Kaiser Permanente Health Care - Portland
  - Salem, Oregon, Forente stater, 97309-5014
    - Salem Hospital Regional Cancer Care Services
- Pennsylvania
  - Allentown, Pennsylvania, Forente stater, 18105
    - Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  - Danville, Pennsylvania, Forente stater, 17822-0001
    - Geisinger Medical Center
  - DuBois, Pennsylvania, Forente stater, 15801
    - Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
  - Easton, Pennsylvania, Forente stater, 18042
    - Easton Regional Cancer Center at Easton Hospital
  - Harrisburg, Pennsylvania, Forente stater, 17105
    - PinnacleHealth Regional Cancer Center at Polyclinic Hospital
  - Lancaster, Pennsylvania, Forente stater, 17604
    - Lancaster General Hospital
  - Langhorne, Pennsylvania, Forente stater, 19047
    - St. Mary Regional Cancer Center
  - Pittsburgh, Pennsylvania, Forente stater, 15212
    - Allegheny Cancer Center at Allegheny General Hospital
  - Scranton, Pennsylvania, Forente stater, 18501
    - Mercy Hospital Cancer Center - Scranton
  - Scranton, Pennsylvania, Forente stater, 18510
    - Hematology and Oncology Associates of Northeastern Pennsylvania
  - State College, Pennsylvania, Forente stater, 16801
    - Geisinger Medical Group - Scenery Park
  - Wilkes-Barre, Pennsylvania, Forente stater, 18711
    - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- South Carolina
  - Anderson, South Carolina, Forente stater, 29621
    - AnMed Cancer Center
  - Charleston, South Carolina, Forente stater, 29425
    - Hollings Cancer Center at Medical University of South Carolina
  - Greenville, South Carolina, Forente stater, 29615
    - CCOP - Greenville
  - Greenville, South Carolina, Forente stater, 29601
    - Bon Secours St. Francis Health System
  - Spartanburg, South Carolina, Forente stater, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, Forente stater, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- South Dakota
  - Rapid City, South Dakota, Forente stater, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, Forente stater, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, Forente stater, 57117-5039
    - Sioux Valley Hospital and University of South Dakota Medical Center
  - Sioux Falls, South Dakota, Forente stater, 57105
    - Medical X-Ray Center, PC
- Tennessee
  - Knoxville, Tennessee, Forente stater, 37916
    - Thompson Cancer Survival Center
  - Knoxville, Tennessee, Forente stater, 37920-6999
    - U.T. Cancer Institute at University of Tennessee Medical Center
  - Memphis, Tennessee, Forente stater, 38104
    - University of Tennessee Cancer Institute - Medical Center
- Texas
  - Dallas, Texas, Forente stater, 75230
    - Medical City Dallas Hospital
  - Fort Sam Houston, Texas, Forente stater, 78234
    - Brooke Army Medical Center
  - Houston, Texas, Forente stater, 77030
    - Ben Taub General Hospital
  - Houston, Texas, Forente stater, 77030
    - Methodist Hospital
  - Houston, Texas, Forente stater, 77030
    - Veterans Affairs Medical Center - Houston
  - Houston, Texas, Forente stater, 77030
    - Baylor University Medical Center - Houston
  - Houston, Texas, Forente stater, 77030
    - St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
  - Lackland Air Force Base, Texas, Forente stater, 78236
    - Wilford Hall Medical Center
  - Lubbock, Texas, Forente stater, 79415-3364
    - UMC Southwest Cancer and Research Center
  - San Antonio, Texas, Forente stater, 78229
    - Cancer Therapy and Research Center
  - San Antonio, Texas, Forente stater, 78209
    - Veterans Affairs Medical Center - San Antonio (Murphy)
  - San Antonio, Texas, Forente stater, 78229-3900
    - University of Texas Health Science Center at San Antonio
  - San Antonio, Texas, Forente stater, 78229
    - University Hospital - San Antonio
  - Temple, Texas, Forente stater, 76508
    - CCOP - Scott and White Hospital
- Utah
  - American Fork, Utah, Forente stater, 84003
    - American Fork Hospital
  - Logan, Utah, Forente stater, 84321
    - Logan Regional Hospital
  - Murray, Utah, Forente stater, 84107
    - Cottonwood Hospital Medical Center
  - Ogden, Utah, Forente stater, 84403
    - McKay-Dee Hospital Center
  - Provo, Utah, Forente stater, 84604
    - Utah Valley Regional Medical Center - Provo
  - Saint George, Utah, Forente stater, 84770
    - Dixie Regional Medical Center - East Campus
  - Salt Lake City, Utah, Forente stater, 84112
    - Huntsman Cancer Institute at University of Utah
  - Salt Lake City, Utah, Forente stater, 84106
    - Utah Cancer Specialists at UCS Cancer Center
  - Salt Lake City, Utah, Forente stater, 84143
    - Latter Day Saints Hospital
- Virginia
  - Charlottesville, Virginia, Forente stater, 22901
    - Martha Jefferson Hospital Cancer Care Center
  - Danville, Virginia, Forente stater, 24541
    - Danville Regional Medical Center
  - Lynchburg, Virginia, Forente stater, 24501
    - Lynchburg Hematology-Oncology Clinic
  - Newport News, Virginia, Forente stater, 23601
    - Peninsula Cancer Institute - Newport News Office
  - Richmond, Virginia, Forente stater, 23249
    - Veterans Affairs Medical Center - Richmond
- Washington
  - Auburn, Washington, Forente stater, 98002
    - Auburn Regional Center for Cancer Care
  - Bellingham, Washington, Forente stater, 98225
    - St. Joseph Cancer Center
  - Bremerton, Washington, Forente stater, 98310
    - Olympic Hematology and Oncology
  - Centralia, Washington, Forente stater, 98531-9027
    - Providence Centralia Hospital Regional Cancer Center
  - Federal Way, Washington, Forente stater, 98003
    - St. Francis Hospital
  - Mount Vernon, Washington, Forente stater, 98273
    - Skagit Valley Hospital Cancer Care Center
  - Olympia, Washington, Forente stater, 98506-5166
    - Providence St. Peter Hospital Regional Cancer Center
  - Puyallup, Washington, Forente stater, 98372
    - Good Samaritan Cancer Center
  - Seattle, Washington, Forente stater, 98104
    - Harborview Medical Center
  - Seattle, Washington, Forente stater, 98104
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, Forente stater, 98104
    - Minor and James Medical, PLLC
  - Seattle, Washington, Forente stater, 98112
    - Group Health Central Hospital
  - Seattle, Washington, Forente stater, 98122-4307
    - Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  - Seattle, Washington, Forente stater, 98122
    - Polyclinic First Hill
  - Seattle, Washington, Forente stater, 98195-6043
    - University Cancer Center at University of Washington Medical Center
  - Spokane, Washington, Forente stater, 99202
    - Cancer Care Northwest - Spokane South
  - Spokane, Washington, Forente stater, 99204-2967
    - Rockwood Clinic Cancer Treatment Center
  - Spokane, Washington, Forente stater, 99204
    - Providence Cancer Center at Sacred Heart Medical Center
  - Spokane, Washington, Forente stater, 99207
    - Providence Cancer Center at Holy Family Hospital
  - Tacoma, Washington, Forente stater, 98405
    - Allenmore Hospital
  - Tacoma, Washington, Forente stater, 98405
    - CCOP - Northwest
  - Tacoma, Washington, Forente stater, 98405
    - MultiCare Regional Cancer Center at Tacoma General Hospital
  - Tacoma, Washington, Forente stater, 98499
    - St. Clare Hospital
  - Tacoma, Washington, Forente stater, 98405-3004
    - St. Joseph Medical Center at Franciscan Health System
  - Wenatchee, Washington, Forente stater, 98801-2028
    - Wenatchee Valley Medical Center
- Wisconsin
  - Appleton, Wisconsin, Forente stater, 54911-3496
    - Fox Valley Hematology and Oncology - East Grant Street
  - Green Bay, Wisconsin, Forente stater, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, Forente stater, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, Forente stater, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - Green Bay, Wisconsin, Forente stater, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital
  - Janesville, Wisconsin, Forente stater, 53547
    - Mercy Regional Cancer Center
  - La Crosse, Wisconsin, Forente stater, 54601
    - Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  - Manitowoc, Wisconsin, Forente stater, 54221-1450
    - Holy Family Memorial Medical Center Cancer Care Center
  - Marinette, Wisconsin, Forente stater, 54143
    - Bay Area Cancer Care Center at Bay Area Medical Center
  - Marshfield, Wisconsin, Forente stater, 54449
    - Marshfield Clinic - Marshfield Center
  - Oconto Falls, Wisconsin, Forente stater, 54154
    - Green Bay Oncology, Limited - Oconto Falls
  - Racine, Wisconsin, Forente stater, 53405
    - All Saints Cancer Center at Wheaton Franciscan Healthcare
  - Rice Lake, Wisconsin, Forente stater, 54868
    - Marshfield Clinic - Indianhead Center
  - Sturgeon Bay, Wisconsin, Forente stater, 54235
    - Green Bay Oncology, Limited - Sturgeon Bay
  - Wausau, Wisconsin, Forente stater, 54401
    - University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- Wyoming
  - Sheridan, Wyoming, Forente stater, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 120 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC)
Measurable or evaluable disease by CT scan, MRI, x-ray, physical exam, or nuclear exam
Brain metastases allowed if previously treated with radiotherapy and/or surgery and are neurologically stable (i.e., no progressing symptoms and off steroids and anticonvulsants)

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

WBC at least 3,000/mm^3
Absolute granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST or ALT no greater than 2.5 times ULN

Renal

Creatinine normal
Creatinine clearance at least 50 mL/min

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
HIV negative
No concurrent AIDS-related illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior biologic therapy for SCLC
No filgrastim (G-CSF) within 24 hours of chemotherapy

Chemotherapy

No prior systemic chemotherapy for SCLC

Endocrine therapy

See Disease Characteristics

Radiotherapy

See Disease Characteristics
At least 21 days since prior brain radiotherapy and recovered
No other prior radiotherapy for SCLC

Surgery

See Disease Characteristics
At least 21 days since prior thoracic or other major surgery and recovered

Other

No concurrent enzyme inducing antiepileptic drugs (phenytoin, phenobarbital, oxcarboxepine, or carbamazepine)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Ingen (Open Label)

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Aktiv komparator: 2	Legemiddel: cisplatin Arm 1: 60 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles Arm 2: 80 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles Legemiddel: etoposide 100 mg/m2 IV (over 30-60 min) on Days 1 , 2 & 3. Q 3 weeks x 4 Cycles
Aktiv komparator: 1	Legemiddel: cisplatin Arm 1: 60 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles Arm 2: 80 mg/m2 IV (over 30-60 min) on Day 1, Q 4 weeks x 4 Cycles Legemiddel: irinotecan hydrochloride 60 mg/m2 IV (over 90 min)on Days 1, 8 & 15. Q 4 weeks x 4 Cycles

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Overall Survival Tidsramme: Weekly while on treatment, then every 3 months for first year, then every 6 months unitl a maximum of 3 years from enrollment.	Overall survival was defined as the duration between the date of randomization( enrollment) and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.	Weekly while on treatment, then every 3 months for first year, then every 6 months unitl a maximum of 3 years from enrollment.

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Progression-free Survival Tidsramme: Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment.	Progression-Free Survival was defined as the duration from the date of randomization (enrollment) until the date of documentation of progression as defined by RECIST (a 20% increase over nadir in the sum of longest diameters of target lesions, clear progression of a non-target lesion in the opinion of the treating investigator, appearance of new lesions, or symptomatic deterioration) or death due to any cause. Patients last known to be alive and without evidence of progression were censored at the date of last contact.	Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment.
Confirmed and Unconfirmed Complete and Partial Responses. Tidsramme: Every 6 weeks while on protocol treatment for a maximum of 12 weeks	Patients underwent chest CT/MRI every 6 weeks while on treatment and tumor response was evaluated by RECIST in the subset of patients with at least one target lesion at baseline. A target lesion was defined as a lesion with a longest diameter of at least 2 cm ( or at least 1 cm if by spiral CT). A complete response (CR) was defined as the disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a 30% or greater decrease in the sum of the longest diameters. Confirmation of a CR or PR was defined as a second determination of CR or PR at least 4 weeks after the first determination.	Every 6 weeks while on protocol treatment for a maximum of 12 weeks
Number of Patients With a Given Type and Grade of Adverse Event. Tidsramme: Every 4 weeks while subject on protocol treatment for a maximum of 12 weeks.	Only adverse events that are possibly, probably or definitely related to study drug are reported. Only patients who received protocol treatment and were assessed for adverse events are included.	Every 4 weeks while subject on protocol treatment for a maximum of 12 weeks.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Southwest Oncology Group

Samarbeidspartnere

National Cancer Institute (NCI)

Cancer and Leukemia Group B

North Central Cancer Treatment Group

Etterforskere

Hovedetterforsker: Primo N. Lara, MD, University of California, Davis
Hovedetterforsker: Ronald B. Natale, MD, Cedars-Sinai Medical Center
Hovedetterforsker: David R. Gandara, MD, University of California, Davis
Hovedetterforsker: James R. Jett, MD, Mayo Clinic
Hovedetterforsker: Jane Carleton, MD, Don Monti Comprehensive Cancer Center at North Shore University Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Lara PN Jr, Chansky K, Shibata T, Fukuda H, Tamura T, Crowley J, Redman MW, Natale R, Saijo N, Gandara DR. Common arm comparative outcomes analysis of phase 3 trials of cisplatin + irinotecan versus cisplatin + etoposide in extensive stage small cell lung cancer: final patient-level results from Japan Clinical Oncology Group 9511 and Southwest Oncology Group 0124. Cancer. 2010 Dec 15;116(24):5710-5. doi: 10.1002/cncr.25532. Epub 2010 Aug 24.
Lara PN Jr, Natale R, Crowley J, Lenz HJ, Redman MW, Carleton JE, Jett J, Langer CJ, Kuebler JP, Dakhil SR, Chansky K, Gandara DR. Phase III trial of irinotecan/cisplatin compared with etoposide/cisplatin in extensive-stage small-cell lung cancer: clinical and pharmacogenomic results from SWOG S0124. J Clin Oncol. 2009 May 20;27(15):2530-5. doi: 10.1200/JCO.2008.20.1061. Epub 2009 Apr 6.
Natale RB, Lara PN, Chansky K, et al.: S0124: A randomized phase III trial comparing irinotecan/cisplatin (IP) with etoposide/cisplatin (EP) in patients (pts) with previously untreated extensive stage small cell lung cancer (E-SCLC). [Abstract] J Clin Oncol 26 (Suppl 15): A-7512, 2008.
Hanna N, Bunn PA Jr, Langer C, Einhorn L, Guthrie T Jr, Beck T, Ansari R, Ellis P, Byrne M, Morrison M, Hariharan S, Wang B, Sandler A. Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer. J Clin Oncol. 2006 May 1;24(13):2038-43. doi: 10.1200/JCO.2005.04.8595.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2002

Primær fullføring (Faktiske)

1. mars 2008

Studiet fullført (Faktiske)

1. desember 2009

Datoer for studieregistrering

Først innsendt

6. september 2002

Først innsendt som oppfylte QC-kriteriene

26. januar 2003

Først lagt ut (Anslag)

27. januar 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. juli 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juli 2018

Sist bekreftet

1. juli 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

småcellet lungekreft i omfattende stadium

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

CDR0000256908
U10CA032102 (U.S. NIH-stipend/kontrakt)
S0124 (Annen identifikator: CALGB)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

S0124: Cisplatin Combined With Irinotecan or Etoposide For Extensive-Stage Small Cell Lung Cancer

Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Studietype

Registrering (Faktiske)

Fase

Kontakter og plasseringer

Studiesteder

Deltakelseskriterier

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Beskrivelse

Studieplan

Hvordan er studiet utformet?

Designdetaljer

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm

Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Samarbeidspartnere og etterforskere

Sponsor

Samarbeidspartnere

Etterforskere

Publikasjoner og nyttige lenker

Generelle publikasjoner

Studierekorddatoer

Studer hoveddatoer

Studiestart

Primær fullføring (Faktiske)

Studiet fullført (Faktiske)

Datoer for studieregistrering

Først innsendt

Først innsendt som oppfylte QC-kriteriene

Først lagt ut (Anslag)

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Sist bekreftet

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre