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

This study has been completed.
Sponsor:
Collaborators:
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00045162
First received: September 6, 2002
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: etoposide
Drug: irinotecan hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment. ] [ Designated as safety issue: No ]
    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.

  • Confirmed and Unconfirmed Complete and Partial Responses. [ Time Frame: Every 6 weeks while on protocol treatment for a maximum of 12 weeks ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 671
Study Start Date: November 2002
Study Completion Date: December 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045162

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

Additional Information:
Publications:
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.
Lara P, Chansky K, Shibata T, et al.: Cisplatin + irinotecan versus cisplatin + etoposide in extensive stage small cell lung cancer (E-SCLC): Final "common arm": comparative outcomes analysis of JCOG 9511 and SWOG 0124. [Abstract] J Clin Oncol 27 (Suppl 15): A-8027, 2009.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00045162     History of Changes
Other Study ID Numbers: CDR0000256908, S0124, S0124, S0124, U10CA032102
Study First Received: September 6, 2002
Results First Received: April 16, 2013
Last Updated: July 3, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Irinotecan
Cisplatin
Etoposide
Camptothecin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 20, 2014