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

20. august 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

760

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Charleroi, Belgien, 6000
        • GSK Clinical Trials Call Center
      • Edegem, Belgien, 2650
        • GSK Clinical Trials Call Center
      • Haine-Saint- Paul, Belgien, 7100
        • GSK Clinical Trials Call Center
      • Leuven, Belgien, 3000
        • GSK Clinical Trials Call Center
      • Liege, Belgien, 4000
        • GSK Clinical Trials Call Center
      • Luxembourg, Belgien, 1210
        • GSK Clinical Trials Call Center
  • Brasilien
      • Belo Horizonte, Brasilien, 30140-083
        • GSK Clinical Trials Call Center
      • Caxias do Sul, Brasilien, 95010-060
        • GSK Clinical Trials Call Center
      • Fortaleza, Brasilien, 60430-230
        • GSK Clinical Trials Call Center
      • Porto Alegre, Brasilien, 90020-090
        • GSK Clinical Trials Call Center
      • Porto Alegre, Brasilien, 90035-003
        • GSK Clinical Trials Call Center
      • Rio de Janeiro, Brasilien, 20230-130
        • GSK Clinical Trials Call Center
      • Salvador, Brasilien, 41920-000
        • GSK Clinical Trials Call Center
      • Sao Paulo, Brasilien, 04023-062
        • GSK Clinical Trials Call Center
      • Sao Paulo, Brasilien, 05403-900
        • GSK Clinical Trials Call Center
  • Bulgarien
      • Bourgas, Bulgarien, 8000
        • GSK Clinical Trials Call Center
      • Plovdiv, Bulgarien, 4000
        • GSK Clinical Trials Call Center
      • Sofia, Bulgarien, 1000/1527
        • GSK Clinical Trials Call Center
      • Sofia, Bulgarien, 1156
        • GSK Clinical Trials Call Center
      • Varna, Bulgarien, 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 Føderation
      • Moscow, Den Russiske Føderation, 107 055
        • GSK Clinical Trials Call Center
      • Moscow, Den Russiske Føderation, 115 478
        • GSK Clinical Trials Call Center
      • Moscow Region, Den Russiske Føderation, 143 423
        • GSK Clinical Trials Call Center
  • Det Forenede Kongerige
      • Glasgow, Det Forenede Kongerige, G4 0SF
        • GSK Clinical Trials Call Center
      • Leeds, Det Forenede Kongerige, LS16 6QB
        • GSK Clinical Trials Call Center
      • Leicester, Det Forenede Kongerige, LE1 5WW
        • GSK Clinical Trials Call Center
      • Poole, Det Forenede Kongerige, BH15 2JB
        • GSK Clinical Trials Call Center
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, Det Forenede Kongerige, AB25 2ZD
        • GSK Clinical Trials Call Center
    • Nottinghamshire
      • Nottingham, Nottinghamshire, Det Forenede Kongerige, NG5 1PB
        • 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
  • Forenede Stater
    • Alabama
      • Hoover, Alabama, Forenede Stater, 35216
        • GSK Clinical Trials Call Center
    • California
      • Chula Vista, California, Forenede Stater, 91911
        • GSK Clinical Trials Call Center
      • Fountain Valley, California, Forenede Stater, 92708
        • GSK Clinical Trials Call Center
      • Greenbrae, California, Forenede Stater, 94904
        • GSK Clinical Trials Call Center
      • Poway, California, Forenede Stater, 92064
        • GSK Clinical Trials Call Center
      • Rancho Mirage, California, Forenede Stater, 92270
        • GSK Clinical Trials Call Center
      • Sacramento, California, Forenede Stater, 95816-5616
        • GSK Clinical Trials Call Center
      • San Diego, California, Forenede Stater, 92102-8421
        • GSK Clinical Trials Call Center
      • San Diego, California, Forenede Stater, 92121
        • GSK Clinical Trials Call Center
      • Soquel, California, Forenede Stater, 95073
        • GSK Clinical Trials Call Center
      • Vista, California, Forenede Stater, 92083
        • GSK Clinical Trials Call Center
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80909
        • GSK Clinical Trials Call Center
    • Connecticut
      • Norwich, Connecticut, Forenede Stater, 06360
        • GSK Clinical Trials Call Center
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20307-5001
        • GSK Clinical Trials Call Center
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610
        • GSK Clinical Trials Call Center
      • Miami Shores, Florida, Forenede Stater, 33138
        • GSK Clinical Trials Call Center
      • Ocala, Florida, Forenede Stater, 34471
        • GSK Clinical Trials Call Center
      • Pensacola, Florida, Forenede Stater, 32501
        • GSK Clinical Trials Call Center
      • Tarpon Springs, Florida, Forenede Stater, 34689
        • GSK Clinical Trials Call Center
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30030
        • GSK Clinical Trials Call Center
      • Atlanta, Georgia, Forenede Stater, 30308
        • GSK Clinical Trials Call Center
      • Atlanta, Georgia, Forenede Stater, 30328
        • GSK Clinical Trials Call Center
      • Atlanta, Georgia, Forenede Stater, 30335
        • GSK Clinical Trials Call Center
      • Augusta, Georgia, Forenede Stater, 30912
        • GSK Clinical Trials Call Center
      • Cummings, Georgia, Forenede Stater, 30040
        • GSK Clinical Trials Call Center
      • Decatur, Georgia, Forenede Stater, 30033
        • GSK Clinical Trials Call Center
    • Illinois
      • Aurora, Illinois, Forenede Stater, 60506
        • GSK Clinical Trials Call Center
      • Chicago, Illinois, Forenede Stater, 60612
        • GSK Clinical Trials Call Center
      • Chicago, Illinois, Forenede Stater, 60637-1470
        • GSK Clinical Trials Call Center
      • Elk Grove Village, Illinois, Forenede Stater, 60007
        • GSK Clinical Trials Call Center
      • Park Ridge, Illinois, Forenede Stater, 60068
        • GSK Clinical Trials Call Center
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47713
        • GSK Clinical Trials Call Center
      • South Bend, Indiana, Forenede Stater, 46601
        • GSK Clinical Trials Call Center
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • GSK Clinical Trials Call Center
      • Shreveport, Louisiana, Forenede Stater, 71103
        • GSK Clinical Trials Call Center
    • Maryland
      • Frederick, Maryland, Forenede Stater, 21701
        • GSK Clinical Trials Call Center
    • Massachusetts
      • Pittsfield, Massachusetts, Forenede Stater, 01201
        • GSK Clinical Trials Call Center
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55404
        • GSK Clinical Trials Call Center
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63141
        • GSK Clinical Trials Call Center
    • Nevada
      • Reno, Nevada, Forenede Stater, 89502
        • GSK Clinical Trials Call Center
    • New Jersey
      • Voorhees, New Jersey, Forenede Stater, 08043
        • GSK Clinical Trials Call Center
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87109
        • GSK Clinical Trials Call Center
    • New York
      • Albany, New York, Forenede Stater, 12208
        • GSK Clinical Trials Call Center
      • New York, New York, Forenede Stater, 10021
        • GSK Clinical Trials Call Center
      • New York, New York, Forenede Stater, 10032
        • GSK Clinical Trials Call Center
      • Rochester, New York, Forenede Stater, 14623
        • GSK Clinical Trials Call Center
      • Valhalla, New York, Forenede Stater, 10595
        • GSK Clinical Trials Call Center
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501
        • GSK Clinical Trials Call Center
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106-5065
        • GSK Clinical Trials Call Center
      • Columbus, Ohio, Forenede Stater, 43222
        • GSK Clinical Trials Call Center
    • Oregon
      • Portland, Oregon, Forenede Stater, 97232-2099
        • GSK Clinical Trials Call Center
    • Pennsylvania
      • Lemoyne, Pennsylvania, Forenede Stater, 17043
        • GSK Clinical Trials Call Center
      • Limerick, Pennsylvania, Forenede Stater, 19468
        • GSK Clinical Trials Call Center
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • GSK Clinical Trials Call Center
    • South Carolina
      • Columbia, South Carolina, Forenede Stater, 29203
        • GSK Clinical Trials Call Center
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • GSK Clinical Trials Call Center
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38119
        • GSK Clinical Trials Call Center
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76104
        • GSK Clinical Trials Call Center
      • Houston, Texas, Forenede Stater, 77060
        • GSK Clinical Trials Call Center
    • Virginia
      • Abingdon, Virginia, Forenede Stater, 24211
        • GSK Clinical Trials Call Center
      • Norfolk, Virginia, Forenede Stater, 23502
        • GSK Clinical Trials Call Center
    • Washington
      • Olympia, Washington, Forenede Stater, 98506
        • GSK Clinical Trials Call Center
      • Yakima, Washington, Forenede Stater, 98902
        • GSK Clinical Trials Call Center
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26506
        • GSK Clinical Trials Call Center
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • GSK Clinical Trials Call Center
    • Wyoming
      • Laramie, Wyoming, Forenede Stater, 82070
        • GSK Clinical Trials Call Center
  • Frankrig
      • Caen, Frankrig, 14076
        • GSK Clinical Trials Call Center
      • Calais Cedex, Frankrig, 62107
        • GSK Clinical Trials Call Center
      • Strasbourg, Frankrig, 67091
        • GSK Clinical Trials Call Center
      • Vesoul, Frankrig, 70014
        • GSK Clinical Trials Call Center
  • Holland
      • Apeldoorn, Holland, 7334 DZ
        • GSK Clinical Trials Call Center
      • Arnheim, Holland, 6815 AD
        • GSK Clinical Trials Call Center
      • Ede, Holland, 6716 RP
        • GSK Clinical Trials Call Center
      • Harderwijk, Holland, 3844 DG
        • GSK Clinical Trials Call Center
      • Nieuwegein, Holland, 3435 CM
        • GSK Clinical Trials Call Center
  • Honduras
      • Tegucigalpa, Honduras
        • GSK Clinical Trials Call Center
  • Italien
      • Lazio, Italien, 149
        • GSK Clinical Trials Call Center
      • Roma, Italien, 149
        • GSK Clinical Trials Call Center
      • Roma, Italien, 184
        • GSK Clinical Trials Call Center
    • Liguria
      • Genova, Liguria, Italien, 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
  • 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
  • Slovakiet
      • Banska Bystrica, Slovakiet, 975 17
        • GSK Clinical Trials Call Center
      • Bratislava, Slovakiet, 825 56
        • GSK Clinical Trials Call Center
      • Kosice, Slovakiet, 041 09
        • GSK Clinical Trials Call Center
      • Nitra, Slovakiet, 949 88
        • GSK Clinical Trials Call Center
  • Spanien
      • Lerida, Spanien, 25198
        • GSK Clinical Trials Call Center
      • Valencia, Spanien, 46009
        • GSK Clinical Trials Call Center
  • Sydafrika
    • Gauteng
      • Johannesburg, Gauteng, Sydafrika, 2193
        • GSK Clinical Trials Call Center
  • Taiwan
      • Taipei, Taiwan, 100
        • GSK Clinical Trials Call Center
      • Taipei, Taiwan, 105
        • GSK Clinical Trials Call Center
  • Tjekkiet
      • Hradec Kralove, Tjekkiet, 500 05
        • GSK Clinical Trials Call Center
      • Olomouc, Tjekkiet, 775 25
        • GSK Clinical Trials Call Center
      • Plzen, Tjekkiet, 305 99
        • GSK Clinical Trials Call Center
      • Praha, Tjekkiet, 121 00
        • GSK Clinical Trials Call Center
      • Praha, Tjekkiet, 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
  • Østrig
      • Vienna, Østrig, A-1090
        • GSK Clinical Trials Call Center
      • Vienna, Østrig, A-1130
        • GSK Clinical Trials Call Center
      • Vienna, Østrig, A-1140
        • GSK Clinical Trials Call Center

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:

  • 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

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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Samlet overlevelse

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Efterforskere

  • Studieleder: GSK Clinical Trial, MD, GlaxoSmithKline

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. april 2001

Primær færdiggørelse (Faktiske)

1. januar 2004

Datoer for studieregistrering

Først indsendt

14. august 2002

Først indsendt, der opfyldte QC-kriterier

15. august 2002

Først opslået (Skøn)

16. august 2002

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. august 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. august 2013

Sidst verificeret

1. august 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 104864-A/389

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 .

Abonner