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Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults

20. august 2013 oppdatert av: GlaxoSmithKline

An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer.

This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering

760

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Belgia
      • Charleroi, Belgia, 6000
        • GSK Clinical Trials Call Center
      • Edegem, Belgia, 2650
        • GSK Clinical Trials Call Center
      • Haine-Saint- Paul, Belgia, 7100
        • GSK Clinical Trials Call Center
      • Leuven, Belgia, 3000
        • GSK Clinical Trials Call Center
      • Liege, Belgia, 4000
        • GSK Clinical Trials Call Center
      • Luxembourg, Belgia, 1210
        • GSK Clinical Trials Call Center
  • Brasil
      • Belo Horizonte, Brasil, 30140-083
        • GSK Clinical Trials Call Center
      • Caxias do Sul, Brasil, 95010-060
        • GSK Clinical Trials Call Center
      • Fortaleza, Brasil, 60430-230
        • GSK Clinical Trials Call Center
      • Porto Alegre, Brasil, 90020-090
        • GSK Clinical Trials Call Center
      • Porto Alegre, Brasil, 90035-003
        • GSK Clinical Trials Call Center
      • Rio de Janeiro, Brasil, 20230-130
        • GSK Clinical Trials Call Center
      • Salvador, Brasil, 41920-000
        • GSK Clinical Trials Call Center
      • Sao Paulo, Brasil, 04023-062
        • GSK Clinical Trials Call Center
      • Sao Paulo, Brasil, 05403-900
        • GSK Clinical Trials Call Center
  • Bulgaria
      • Bourgas, Bulgaria, 8000
        • GSK Clinical Trials Call Center
      • Plovdiv, Bulgaria, 4000
        • GSK Clinical Trials Call Center
      • Sofia, Bulgaria, 1000/1527
        • GSK Clinical Trials Call Center
      • Sofia, Bulgaria, 1156
        • GSK Clinical Trials Call Center
      • Varna, Bulgaria, 9010
        • GSK Clinical Trials Call Center
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • GSK Clinical Trials Call Center
      • Edmonton, Alberta, Canada, T6G 1E2
        • GSK Clinical Trials Call Center
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • GSK Clinical Trials Call Center
    • Nova Scotia
      • Sydney, Nova Scotia, Canada, B1P 1P3
        • GSK Clinical Trials Call Center
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • GSK Clinical Trials Call Center
      • Oshawa, Ontario, Canada, L1G 2B9
        • GSK Clinical Trials Call Center
      • Ottawa, Ontario, Canada, K1H 1C4
        • GSK Clinical Trials Call Center
      • Peterborough, Ontario, Canada, K9H 7B6
        • GSK Clinical Trials Call Center
      • Sault Sainte Marie, Ontario, Canada, P6B 1Y5
        • GSK Clinical Trials Call Center
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • GSK Clinical Trials Call Center
      • Toronto, Ontario, Canada, M5G 2M9
        • GSK Clinical Trials Call Center
      • Weston, Ontario, Canada, M9N 1N8
        • GSK Clinical Trials Call Center
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • GSK Clinical Trials Call Center
      • Montreal, Quebec, Canada, H1T 2M4
        • GSK Clinical Trials Call Center
      • Montreal, Quebec, Canada, H2L 4M1
        • GSK Clinical Trials Call Center
      • Montreal, Quebec, Canada, H3T 1E2
        • GSK Clinical Trials Call Center
      • Sainte-Foy, Quebec, Canada, G1V 4G5
        • GSK Clinical Trials Call Center
  • Chile
      • Santiago, Chile
        • GSK Clinical Trials Call Center
  • Costa Rica
      • San Jose, Costa Rica
        • GSK Clinical Trials Call Center
  • Den russiske føderasjonen
      • Moscow, Den russiske føderasjonen, 107 055
        • GSK Clinical Trials Call Center
      • Moscow, Den russiske føderasjonen, 115 478
        • GSK Clinical Trials Call Center
      • Moscow Region, Den russiske føderasjonen, 143 423
        • GSK Clinical Trials Call Center
  • Estland
      • Tallinn, Estland, 11619
        • GSK Clinical Trials Call Center
  • Finland
      • Helsinki, Finland, 29
        • GSK Clinical Trials Call Center
      • Kangasala, Finland, 36280
        • GSK Clinical Trials Call Center
      • Oulu, Finland, 90029
        • GSK Clinical Trials Call Center
  • Forente stater
    • Alabama
      • Hoover, Alabama, Forente stater, 35216
        • GSK Clinical Trials Call Center
    • California
      • Chula Vista, California, Forente stater, 91911
        • GSK Clinical Trials Call Center
      • Fountain Valley, California, Forente stater, 92708
        • GSK Clinical Trials Call Center
      • Greenbrae, California, Forente stater, 94904
        • GSK Clinical Trials Call Center
      • Poway, California, Forente stater, 92064
        • GSK Clinical Trials Call Center
      • Rancho Mirage, California, Forente stater, 92270
        • GSK Clinical Trials Call Center
      • Sacramento, California, Forente stater, 95816-5616
        • GSK Clinical Trials Call Center
      • San Diego, California, Forente stater, 92102-8421
        • GSK Clinical Trials Call Center
      • San Diego, California, Forente stater, 92121
        • GSK Clinical Trials Call Center
      • Soquel, California, Forente stater, 95073
        • GSK Clinical Trials Call Center
      • Vista, California, Forente stater, 92083
        • GSK Clinical Trials Call Center
    • Colorado
      • Colorado Springs, Colorado, Forente stater, 80909
        • GSK Clinical Trials Call Center
    • Connecticut
      • Norwich, Connecticut, Forente stater, 06360
        • GSK Clinical Trials Call Center
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20307-5001
        • GSK Clinical Trials Call Center
    • Florida
      • Gainesville, Florida, Forente stater, 32610
        • GSK Clinical Trials Call Center
      • Miami Shores, Florida, Forente stater, 33138
        • GSK Clinical Trials Call Center
      • Ocala, Florida, Forente stater, 34471
        • GSK Clinical Trials Call Center
      • Pensacola, Florida, Forente stater, 32501
        • GSK Clinical Trials Call Center
      • Tarpon Springs, Florida, Forente stater, 34689
        • GSK Clinical Trials Call Center
    • Georgia
      • Atlanta, Georgia, Forente stater, 30030
        • GSK Clinical Trials Call Center
      • Atlanta, Georgia, Forente stater, 30308
        • GSK Clinical Trials Call Center
      • Atlanta, Georgia, Forente stater, 30328
        • GSK Clinical Trials Call Center
      • Atlanta, Georgia, Forente stater, 30335
        • GSK Clinical Trials Call Center
      • Augusta, Georgia, Forente stater, 30912
        • GSK Clinical Trials Call Center
      • Cummings, Georgia, Forente stater, 30040
        • GSK Clinical Trials Call Center
      • Decatur, Georgia, Forente stater, 30033
        • GSK Clinical Trials Call Center
    • Illinois
      • Aurora, Illinois, Forente stater, 60506
        • GSK Clinical Trials Call Center
      • Chicago, Illinois, Forente stater, 60612
        • GSK Clinical Trials Call Center
      • Chicago, Illinois, Forente stater, 60637-1470
        • GSK Clinical Trials Call Center
      • Elk Grove Village, Illinois, Forente stater, 60007
        • GSK Clinical Trials Call Center
      • Park Ridge, Illinois, Forente stater, 60068
        • GSK Clinical Trials Call Center
    • Indiana
      • Evansville, Indiana, Forente stater, 47713
        • GSK Clinical Trials Call Center
      • South Bend, Indiana, Forente stater, 46601
        • GSK Clinical Trials Call Center
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70112
        • GSK Clinical Trials Call Center
      • Shreveport, Louisiana, Forente stater, 71103
        • GSK Clinical Trials Call Center
    • Maryland
      • Frederick, Maryland, Forente stater, 21701
        • GSK Clinical Trials Call Center
    • Massachusetts
      • Pittsfield, Massachusetts, Forente stater, 01201
        • GSK Clinical Trials Call Center
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55404
        • GSK Clinical Trials Call Center
    • Missouri
      • St. Louis, Missouri, Forente stater, 63141
        • GSK Clinical Trials Call Center
    • Nevada
      • Reno, Nevada, Forente stater, 89502
        • GSK Clinical Trials Call Center
    • New Jersey
      • Voorhees, New Jersey, Forente stater, 08043
        • GSK Clinical Trials Call Center
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87109
        • GSK Clinical Trials Call Center
    • New York
      • Albany, New York, Forente stater, 12208
        • GSK Clinical Trials Call Center
      • New York, New York, Forente stater, 10021
        • GSK Clinical Trials Call Center
      • New York, New York, Forente stater, 10032
        • GSK Clinical Trials Call Center
      • Rochester, New York, Forente stater, 14623
        • GSK Clinical Trials Call Center
      • Valhalla, New York, Forente stater, 10595
        • GSK Clinical Trials Call Center
    • North Dakota
      • Bismarck, North Dakota, Forente stater, 58501
        • GSK Clinical Trials Call Center
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106-5065
        • GSK Clinical Trials Call Center
      • Columbus, Ohio, Forente stater, 43222
        • GSK Clinical Trials Call Center
    • Oregon
      • Portland, Oregon, Forente stater, 97232-2099
        • GSK Clinical Trials Call Center
    • Pennsylvania
      • Lemoyne, Pennsylvania, Forente stater, 17043
        • GSK Clinical Trials Call Center
      • Limerick, Pennsylvania, Forente stater, 19468
        • GSK Clinical Trials Call Center
      • Philadelphia, Pennsylvania, Forente stater, 19140
        • GSK Clinical Trials Call Center
    • South Carolina
      • Columbia, South Carolina, Forente stater, 29203
        • GSK Clinical Trials Call Center
      • Spartanburg, South Carolina, Forente stater, 29303
        • GSK Clinical Trials Call Center
    • Tennessee
      • Memphis, Tennessee, Forente stater, 38119
        • GSK Clinical Trials Call Center
    • Texas
      • Fort Worth, Texas, Forente stater, 76104
        • GSK Clinical Trials Call Center
      • Houston, Texas, Forente stater, 77060
        • GSK Clinical Trials Call Center
    • Virginia
      • Abingdon, Virginia, Forente stater, 24211
        • GSK Clinical Trials Call Center
      • Norfolk, Virginia, Forente stater, 23502
        • GSK Clinical Trials Call Center
    • Washington
      • Olympia, Washington, Forente stater, 98506
        • GSK Clinical Trials Call Center
      • Yakima, Washington, Forente stater, 98902
        • GSK Clinical Trials Call Center
    • West Virginia
      • Morgantown, West Virginia, Forente stater, 26506
        • GSK Clinical Trials Call Center
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
        • GSK Clinical Trials Call Center
    • Wyoming
      • Laramie, Wyoming, Forente stater, 82070
        • GSK Clinical Trials Call Center
  • Frankrike
      • Caen, Frankrike, 14076
        • GSK Clinical Trials Call Center
      • Calais Cedex, Frankrike, 62107
        • GSK Clinical Trials Call Center
      • Strasbourg, Frankrike, 67091
        • GSK Clinical Trials Call Center
      • Vesoul, Frankrike, 70014
        • GSK Clinical Trials Call Center
  • Honduras
      • Tegucigalpa, Honduras
        • GSK Clinical Trials Call Center
  • Italia
      • Lazio, Italia, 149
        • GSK Clinical Trials Call Center
      • Roma, Italia, 149
        • GSK Clinical Trials Call Center
      • Roma, Italia, 184
        • GSK Clinical Trials Call Center
    • Liguria
      • Genova, Liguria, Italia, 16132
        • GSK Clinical Trials Call Center
  • Jamaica
      • Kingston, Jamaica
        • GSK Clinical Trials Call Center
  • Kina
      • Beijing, Kina, 100036
        • GSK Clinical Trials Call Center
      • Shanghai, Kina, 200433
        • GSK Clinical Trials Call Center
      • Wangfujing, Kina, 100730
        • GSK Clinical Trials Call Center
      • Xian, Kina, 710061
        • GSK Clinical Trials Call Center
  • Korea, Republikken
      • Seoul, Korea, Republikken, 110-744
        • GSK Clinical Trials Call Center
      • Seoul, Korea, Republikken, 120-752
        • GSK Clinical Trials Call Center
  • Litauen
      • Kaunas, Litauen, LT-45434
        • GSK Clinical Trials Call Center
      • Vilnius, Litauen, LT-08660
        • GSK Clinical Trials Call Center
  • Mexico
      • Chihuahua, Mexico, 31000
        • GSK Clinical Trials Call Center
      • Guadalajara, Mexico, 44280
        • GSK Clinical Trials Call Center
      • Guadalajara, Mexico, 45170
        • GSK Clinical Trials Call Center
      • Mexico City, Mexico, 14000
        • GSK Clinical Trials Call Center
  • Nederland
      • Apeldoorn, Nederland, 7334 DZ
        • GSK Clinical Trials Call Center
      • Arnheim, Nederland, 6815 AD
        • GSK Clinical Trials Call Center
      • Ede, Nederland, 6716 RP
        • GSK Clinical Trials Call Center
      • Harderwijk, Nederland, 3844 DG
        • GSK Clinical Trials Call Center
      • Nieuwegein, Nederland, 3435 CM
        • GSK Clinical Trials Call Center
  • New Zealand
      • Hamilton, New Zealand, 2001
        • GSK Clinical Trials Call Center
      • Wellington South, New Zealand, 6002
        • GSK Clinical Trials Call Center
  • Norge
      • Oslo, Norge, 407
        • GSK Clinical Trials Call Center
  • Panama
      • Panama, Panama
        • GSK Clinical Trials Call Center
  • Polen
      • Gdansk, Polen, 80-211
        • GSK Clinical Trials Call Center
      • Kielce, Polen, 25-640
        • GSK Clinical Trials Call Center
  • Puerto Rico
      • Ponce, Puerto Rico, 716
        • GSK Clinical Trials Call Center
  • Singapore
      • Singapore, Singapore, 119074
        • GSK Clinical Trials Call Center
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • GSK Clinical Trials Call Center
      • Bratislava, Slovakia, 825 56
        • GSK Clinical Trials Call Center
      • Kosice, Slovakia, 041 09
        • GSK Clinical Trials Call Center
      • Nitra, Slovakia, 949 88
        • GSK Clinical Trials Call Center
  • Spania
      • Lerida, Spania, 25198
        • GSK Clinical Trials Call Center
      • Valencia, Spania, 46009
        • GSK Clinical Trials Call Center
  • Storbritannia
      • Glasgow, Storbritannia, G4 0SF
        • GSK Clinical Trials Call Center
      • Leeds, Storbritannia, LS16 6QB
        • GSK Clinical Trials Call Center
      • Leicester, Storbritannia, LE1 5WW
        • GSK Clinical Trials Call Center
      • Poole, Storbritannia, BH15 2JB
        • GSK Clinical Trials Call Center
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, Storbritannia, AB25 2ZD
        • GSK Clinical Trials Call Center
    • Nottinghamshire
      • Nottingham, Nottinghamshire, Storbritannia, NG5 1PB
        • GSK Clinical Trials Call Center
  • Sør-Afrika
    • Gauteng
      • Johannesburg, Gauteng, Sør-Afrika, 2193
        • GSK Clinical Trials Call Center
  • Taiwan
      • Taipei, Taiwan, 100
        • GSK Clinical Trials Call Center
      • Taipei, Taiwan, 105
        • GSK Clinical Trials Call Center
  • Tsjekkisk Republikk
      • Hradec Kralove, Tsjekkisk Republikk, 500 05
        • GSK Clinical Trials Call Center
      • Olomouc, Tsjekkisk Republikk, 775 25
        • GSK Clinical Trials Call Center
      • Plzen, Tsjekkisk Republikk, 305 99
        • GSK Clinical Trials Call Center
      • Praha, Tsjekkisk Republikk, 121 00
        • GSK Clinical Trials Call Center
      • Praha, Tsjekkisk Republikk, 150 05
        • GSK Clinical Trials Call Center
  • Tyskland
      • Grosshansdorf, Tyskland, 22927
        • GSK Clinical Trials Call Center
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Tyskland, 69126
        • GSK Clinical Trials Call Center
    • Bayern
      • Ebensfeld, Bayern, Tyskland, 96250
        • GSK Clinical Trials Call Center
      • Gauting, Bayern, Tyskland, 82131
        • GSK Clinical Trials Call Center
  • Ungarn
      • Budapest, Ungarn, 1529
        • GSK Clinical Trials Call Center
      • Hungary, Ungarn, 8900
        • GSK Clinical Trials Call Center
  • Østerrike
      • Vienna, Østerrike, A-1090
        • GSK Clinical Trials Call Center
      • Vienna, Østerrike, A-1130
        • GSK Clinical Trials Call Center
      • Vienna, Østerrike, A-1140
        • GSK Clinical Trials Call Center

Deltakelseskriterier

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

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Written informed consent (patient's written understanding of and agreement to participate in this study).
  • Patients with confirmed extensive small cell lung cancer (SCLC).
  • No prior chemotherapy within 5 years of the diagnosis of SCLC.
  • Presence of either measurable or non-measurable SCLC by X-ray or physical examination.
  • At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient).
  • At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting.
  • Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion Criteria:

  • Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids.
  • Any active infection.
  • Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk.
  • Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC.
  • Use of an investigational drug within 30 days before the first dose of study medication.
  • Women who are pregnant or lactating.
  • Patients of child-bearing potential who refuse to practice an adequate form of birth control.
  • Patients with clinical evidence of any stomach or intestinal (GI) condition.
  • Patients requiring treatment with the drug cyclosporin A.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

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

Hva måler studien?

Primære resultatmål

Resultatmål
Total overlevelse

Sekundære resultatmål

Resultatmål
response rates, response duration, time to progression, tolerability and patient-perceived disease status and well being for patients

Samarbeidspartnere og etterforskere

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

Sponsor

GlaxoSmithKline

Etterforskere

  • Studieleder: GSK Clinical Trial, MD, GlaxoSmithKline

Studierekorddatoer

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

Studer hoveddatoer

Studiestart

1. april 2001

Primær fullføring (Faktiske)

1. januar 2004

Datoer for studieregistrering

Først innsendt

14. august 2002

Først innsendt som oppfylte QC-kriteriene

15. august 2002

Først lagt ut (Anslag)

16. august 2002

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

21. august 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. august 2013

Sist bekreftet

1. august 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 104864-A/389

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

Abonnere