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

July 3, 2018 updated by: 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.

Study Overview

Status

Completed

Conditions

Lung Cancer

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

671

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2	Drug: 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 Drug: etoposide 100 mg/m2 IV (over 30-60 min) on Days 1 , 2 & 3. Q 3 weeks x 4 Cycles
Active Comparator: 1	Drug: 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 Drug: irinotecan hydrochloride 60 mg/m2 IV (over 90 min)on Days 1, 8 & 15. Q 4 weeks x 4 Cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Time Frame: 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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival Time Frame: 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. Time Frame: 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. Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Cancer and Leukemia Group B

North Central Cancer Treatment Group

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 6, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

July 31, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

extensive stage small cell lung cancer

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000256908
U10CA032102 (U.S. NIH Grant/Contract)
S0124 (Other Identifier: CALGB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Lung Cancer

Clinical Trials on cisplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations