- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00363415
Study of Pemetrexed and Carboplatin Compared With Etoposide Carboplatin to Treat Extensive-Stage Small Cell Lung Cancer
20. oktober 2009 opdateret af: Eli Lilly and Company
A Randomized Phase 3 Trial of Alimta (Pemetrexed) and Carboplatin Versus Etoposide and Carboplatin in Extensive-Stage Small Cell Lung Cancer
This study is a Phase 3, global, multi-center, open-label study of patients with extensive-stage small cell lung cancer.
Eligible patients will be randomly assigned to receive either pemetrexed plus carboplatin or etoposide plus carboplatin.
It is anticipated that pemetrexed plus carboplatin will offer similar survival benefits as compared to etoposide plus carboplatin.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
908
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Bahia Blanca, Argentina
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Buenos Aires, Argentina, 1427
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Mar Del Plata, Argentina, 7600
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Rosario, Argentina, 2000
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Tucumain, Argentina, 4000
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New South Wales
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Camperdown, New South Wales, Australien, 2050
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Coffs Harbour, New South Wales, Australien, 2450
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Port Macquarie, New South Wales, Australien, 2444
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Wollongong, New South Wales, Australien, 2500
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Queensland
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Brisbane, Queensland, Australien, 4029
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Chermisdie, Queensland, Australien, 4032
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Redcliffe, Queensland, Australien, 4020
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South Brisbane, Queensland, Australien, 4101
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Townsville, Queensland, Australien, 4810
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South Australia
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Adelaide, South Australia, Australien, 5000
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Woodville, South Australia, Australien, 5011
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Tasmania
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Hobart, Tasmania, Australien, 7001
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Victoria
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Frankston, Victoria, Australien, 3199
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Geelong, Victoria, Australien, 3220
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Wodonga, Victoria, Australien, 3690
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Brussels, Belgien, 1090
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Edegem, Belgien, 2650
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Leuven, Belgien, 3000
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Liege, Belgien, 4000
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Liège, Belgien, 4000
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Florianópolis, Brasilien, 88034000
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Fortaleza, Brasilien, 60430-230
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Jau, Brasilien, 17210-120
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Sao Paulo, Brasilien, 01277-900
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Chelyabinsk, Den Russiske Føderation, 454087
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Engels, Den Russiske Føderation, 413115
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Kazan, Den Russiske Føderation, 420029
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Murmansk, Den Russiske Føderation, 183047
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saint Petersburg, Den Russiske Føderation, 198255
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Stavropol, Den Russiske Føderation, 355047
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Manchester, Det Forenede Kongerige, M20 4BX
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Avon
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Bristol, Avon, Det Forenede Kongerige, BS2 8ED
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cornwall
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Truro, Cornwall, Det Forenede Kongerige, TR1 3LJ
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Essex
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Chelmsford, Essex, Det Forenede Kongerige, CM1 7ET
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Scotland
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Aberdeen, Scotland, Det Forenede Kongerige, AB25 2ZN
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Glasgow, Scotland, Det Forenede Kongerige, G12 0YN
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West Midlands
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Birmingham, West Midlands, Det Forenede Kongerige, B15 2TH
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wolverhampton, West Midlands, Det Forenede Kongerige, WV10 0QP
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Alabama
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Huntsville, Alabama, Forenede Stater, 35805
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
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Arkansas
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Fayetteville, Arkansas, Forenede Stater, 72703
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California
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Burbank, California, Forenede Stater, 91505
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La Jolla, California, Forenede Stater, 92093
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Los Angeles, California, Forenede Stater, 90095
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Mission Hills, California, Forenede Stater, 91345
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Orange, California, Forenede Stater, 92868
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Poway, California, Forenede Stater, 92064
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Florida
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Fort Myers, Florida, Forenede Stater, 33916
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Jacksonville, Florida, Forenede Stater, 32256
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Miami, Florida, Forenede Stater, 33136
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Orlando, Florida, Forenede Stater, 32806
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Springfield, Illinois, Forenede Stater, 62701
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Kansas
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Wichita, Kansas, Forenede Stater, 67214
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
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Louisville, Kentucky, Forenede Stater, 40402
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Maine
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Scarborough, Maine, Forenede Stater, 04074
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
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Michigan
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Detroit, Michigan, Forenede Stater, 48201
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Missouri
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Kansas City, Missouri, Forenede Stater, 64111
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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St Louis, Missouri, Forenede Stater, 63110
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68510
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Jersey
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Sparta, New Jersey, Forenede Stater, 07871
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87106
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Santa Fe, New Mexico, Forenede Stater, 87505
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Concord, North Carolina, Forenede Stater, 28025
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45267
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Columbus, Ohio, Forenede Stater, 43221
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Zanesville, Ohio, Forenede Stater, 43701
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oregon
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Portland, Oregon, Forenede Stater, 97213
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
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Dunmore, Pennsylvania, Forenede Stater, 18512
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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East Stroudsburg, Pennsylvania, Forenede Stater, 18301
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ephrata, Pennsylvania, Forenede Stater, 17522
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Media, Pennsylvania, Forenede Stater, 19063
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Philadelphia, Pennsylvania, Forenede Stater, 19141
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29406
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Columbia, South Carolina, Forenede Stater, 29210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404
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Knoxville, Tennessee, Forenede Stater, 37920
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Memphis, Tennessee, Forenede Stater, 38120
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Nashville, Tennessee, Forenede Stater, 37203
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Texas
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Austin, Texas, Forenede Stater, 78705
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Dallas, Texas, Forenede Stater, 75237
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Fort Worth, Texas, Forenede Stater, 76104
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Houston, Texas, Forenede Stater, 77060
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San Antonio, Texas, Forenede Stater, 78258
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Virginia
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Richmond, Virginia, Forenede Stater, 23298
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Washington
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Everett, Washington, Forenede Stater, 98201
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Wisconsin
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Madison, Wisconsin, Forenede Stater, 53792
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Brest, Frankrig, 29609
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Caen, Frankrig, 14033
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Clichy, Frankrig, 92118
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Grenoble, Frankrig, 38043
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Lille, Frankrig, 59020
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Lyon, Frankrig, 69317
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Marseille, Frankrig, 13009
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Montpellier, Frankrig, 34295
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Athens, Grækenland, 11527
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Heraklion, Grækenland, 71110
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Marousi Attikis, Grækenland, 15126
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Pylaia/Thessaloniki, Grækenland, 57001
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Amsterdam, Holland, 1081 HV
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Arnhem, Holland, 6815 AD
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Den Bosch, Holland, 5211 NL
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Groningen, Holland, 9713 GZ
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Harderwijk, Holland, 3844 DG
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Heerlen, Holland, 4619 PC
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Ahmedabad, Indien, 380016
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Bangalore, Indien, 560027
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Kolkata, Indien, 700053
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Ludhiana, Indien, 141001
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Mumbai, Indien, 400 012
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New Delhi, Indien, 110029
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Pune, Indien, 411001
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Trivandrum, Indien, 695 011
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Bergamo, Italien, 24128
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Livorno, Italien, 57128
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Monteforte Irpino, Italien, 83024
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Orbassano, Italien, 10043
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Parma, Italien, 43100
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Ravenna, Italien, 48020
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Rome, Italien, 00149
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San Sisto, Italien, 06156
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Besevler/Ankara, Kalkun, 06500
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Gaziantep, Kalkun
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Istanbul, Kalkun, 34760
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Izmir, Kalkun, 35100
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Samsun, Kalkun, 55139
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Beijing, Kina, 100021
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Guang Zhou, Kina, 510080
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Shanghai, Kina, 200433
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Seoul, Korea, Republikken, 138-736
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Auckland, New Zealand, 1030
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Christchurch, New Zealand, 8020
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Wellington, New Zealand, 6002
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Gdansk, Polen, 80-211
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Krakow-Nowa Huta, Polen, PL-31-826
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Otwock, Polen, 05-400
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Szczecin-Zdunowo, Polen
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Zabrze-Biskupice, Polen, 41-803
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Coimbra, Portugal, 3040-853
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Lisbon, Portugal, 1649-035
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Porto, Portugal, 4200-072
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Santa Maria Da Feira, Portugal, 4520-211
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Vila Nova De Gaia, Portugal, 4434-502
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San Juan, Puerto Rico, 00921
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Bucharest, Rumænien, 022328
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Cluj-Napoca, Rumænien, 3400
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Alicante, Spanien, 03010
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Badalona, Spanien, 08915
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barakaldo, Spanien, 48903
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona, Spanien, 08907
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Madrid, Spanien, 28041
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Zaragoza, Spanien, 50009
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Cape Town, Sydafrika, 7925
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Durban, Sydafrika, 4091
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Parktown, Sydafrika, 2193
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Niao Sung Hsiang, Taiwan, 833
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taichung, Taiwan, 407
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Taipei, Taiwan, 100
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Borstel, Tyskland, 23845
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Freiburg, Tyskland, 79106
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Gauting, Tyskland, D-82131
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Großhansdorf, Tyskland, D-22927
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hamburg, Tyskland, D-21075
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Heidelberg, Tyskland, 69126
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hemer, Tyskland, D-58675
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kassel, Tyskland, 34125
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Köln, Tyskland, D-51109
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nürnberg, Tyskland, 90419
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Regensburg, Tyskland, D-93049
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rostock, Tyskland, 18057
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Stralsund, Tyskland, 18435
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Deszk, Ungarn, 6772
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pecs, Ungarn, 7623
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Szekesfehervar, Ungarn, 8000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Szombathely, Ungarn, 9700
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Torokbalint, Ungarn, 2045
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Zalaegerszeg, Ungarn, 8900
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Graz, Østrig, 8036
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Linz, Østrig, A-4010
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wien, Østrig, A-1140
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of extensive stage small cell lung cancer (SCLC)
- Capable of self-care but may be unable to carry out any work activities.
- No prior anticancer therapy for SCLC
Exclusion Criteria:
- have previously participated in a study involving pemetrexed
- have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: B
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Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
100 mg/m2, intravenous (IV), days 1-3 x 6 cycles
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Eksperimentel: EN
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500 mg/m2, intravenøst (IV), hver 21. dag x 6 cyklusser
Andre navne:
Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Survival
Tidsramme: baseline to date of death from any cause (up to 19.6 months)
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Overall survival is the duration from enrollment to death.
For patients who are alive, overall survival is censored at the last contact.
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baseline to date of death from any cause (up to 19.6 months)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Survival (Subgroups)
Tidsramme: baseline to date of death from any cause (up to 19.6 months)
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The effects of individual baseline factors (sex, race, Eastern Cooperative Oncology Group (ECOG) performance, region, lactate dehydrogenase (LDH), age, number of metastatic sites, and history of brain metastases) on overall survival are reported.
For two subgroups - LDH<=upper limit of normal and brain metastases=yes, the upper limits of the 95% confidence interval were not calculable for the etoposide+carboplatin group - instead the number of participants in these two subgroups are presented as a post-hoc outcome measure.
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baseline to date of death from any cause (up to 19.6 months)
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Progression Free Survival
Tidsramme: baseline to measured progressive disease (up to 14.7 months)
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The period from study entry until disease progression, death or date of last contact.
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baseline to measured progressive disease (up to 14.7 months)
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Change From Baseline to Each Cycle in Functional Assessment of Cancer Therapy - Lung (FACT-L)
Tidsramme: baseline and 6 cycles (21-day cycles)
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FACT-L measures following domains of health-related quality of life (HR-QL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of lung cancer.
Total scores range from 0 to 136, with higher scores representing better HR-QL.
A clinically meaningful change is considered to be 5 points.
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baseline and 6 cycles (21-day cycles)
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Overall Survival (Subgroups: LDH<=Upper Limit of Normal and History of Brain Metastases=Yes)
Tidsramme: baseline to date of death due to any cause (up to 19.6 months)
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The effects of individual baseline factors (lactate dehydrogenase (LDH) and history of brain metastases) on overall survival are reported.
The Upper Limits of the 95% Confidence Intervals were not calculable for these factors in the Etoposide+Carboplatin group.
The number of participants in these subgroup are instead presented as a Post-Hoc Outcome Measure.
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baseline to date of death due to any cause (up to 19.6 months)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2006
Primær færdiggørelse (Faktiske)
1. juni 2008
Studieafslutning (Faktiske)
1. juni 2008
Datoer for studieregistrering
Først indsendt
10. august 2006
Først indsendt, der opfyldte QC-kriterier
10. august 2006
Først opslået (Skøn)
15. august 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. oktober 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. oktober 2009
Sidst verificeret
1. oktober 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Småcellet lungekarcinom
- Molekylære mekanismer for farmakologisk virkning
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Antineoplastiske midler
- Antineoplastiske midler, fytogene
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Folinsyreantagonister
- Carboplatin
- Etoposid
- Pemetrexed
Andre undersøgelses-id-numre
- 9691
- H3E-MC-JMHO
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .