OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Last updated: January 8, 2018
Sponsor: OSI Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT00036647
BR.21
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).

Eligibility Criteria

Inclusion

  • Clinical diagnosis of stage IIIB or IV non-small cell lung cancer.

  • Must have evidence of disease (clinical or radiological).

  • Have failed 1 but no more than 2 prior chemotherapy regimens, have recovered from any side effects and have not had any chemotherapy for at least 21 days.

  • If the patient has had surgery, the surgery was at least 2 weeks ago.

  • Patients whose cancer has spread to their brain or central nervous system are eligible, providing that they have been on stable dose of steroids for at least 4 weeks and are free of symptoms.

  • If the patient received radiation therapy, treatment was at least 4 weeks ago.

Study Design

Total Participants: 731
Study Start date:
November 01, 2001
Estimated Completion Date:
January 30, 2004

Connect with a study center

  • Centro Medico Confidence

    Buenos Aires, CP 1642
    Argentina

    Site Not Available

  • Hospital Britanico

    Buenos Aires, 1280
    Argentina

    Site Not Available

  • Hospital Churruca Visca

    Buenos Aires, C1427
    Argentina

    Site Not Available

  • Hospital Interzonal de Agudos Evita

    Buenos Aires, B1824
    Argentina

    Site Not Available

  • Instituto Alexander fleming

    Buenos Aires, C1426ANZ
    Argentina

    Site Not Available

  • Hospital Italiano

    Capital Federal,
    Argentina

    Site Not Available

  • Instituto Oncologico Angel Roffo

    Capital Federal, CP1417
    Argentina

    Site Not Available

  • Canberra Hospital- Australia

    Woden, Australian Capital Territory 2605
    Australia

    Site Not Available

  • Prince of Wales Hospital

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Newcastle Mater Misericordiae Hospital

    Waratah, New South Wales 2289
    Australia

    Site Not Available

  • Southern Medical Day Care Center

    Wollongong, New South Wales 2500
    Australia

    Site Not Available

  • Western Hospital

    Footscray, Victoria 3011
    Australia

    Site Not Available

  • The Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    South Australia, 5000
    Australia

    Site Not Available

  • Austin & Repatriation Medical Centre

    Victoria, 3084
    Australia

    Site Not Available

  • Peter MacCallum Cancer Institute

    Victoria, 3002
    Australia

    Site Not Available

  • Nucleo de Oncologia da Bahia

    Salvador, Bahia 40170-070
    Brazil

    Site Not Available

  • Instituto do Cancer do Ceara

    Fortaleza, CEP 60430-230
    Brazil

    Site Not Available

  • Instituto Nacional de Cancerologia

    Rio De Janeiro, CEP 20230-130
    Brazil

    Site Not Available

  • Hospital Vera Cruz S/A

    Belo Horizonte, Mg Cep 30190-130
    Brazil

    Site Not Available

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, Rs Cep 90610-000
    Brazil

    Site Not Available

  • Irmandade Santa Casa de Miseicordia de Porto

    Porto Alegre, Rs Cep 90020-090
    Brazil

    Site Not Available

  • Instituto do Cancer Arnaldo Vieira de Carvalho

    Sao Paulo, SP 01224-010
    Brazil

    Site Not Available

  • Faculdade de Medicina do ABC

    Santo Andre, Sp Cep 09060-650
    Brazil

    Site Not Available

  • Escola Paulista de Medicina

    Sao Paulo, Sp Cep 040039-032
    Brazil

    Site Not Available

  • Tom Baker Cancer Centre

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • Cancer Centre for the Southern Interior

    Kelowna, British Columbia V1Y 5L3
    Canada

    Site Not Available

  • BCCA - Vancouver Island

    Victoria, British Columbia V8R 6V5
    Canada

    Site Not Available

  • CancerCare Manitoba (CCMB)

    Winnipeg, Manitoba R3E 0V9
    Canada

    Site Not Available

  • Dr.H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador A1B 3V6
    Canada

    Site Not Available

  • QEII Health Sciences Centre

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • The Royal Victoria Hospital

    Barrie, Ontario L4M 6M2
    Canada

    Site Not Available

  • Hamilton Regional Cancer Centre

    Hamilton, Ontario L9V 5C2
    Canada

    Site Not Available

  • Kingston Regional Cancer Centre

    Kingston, Ontario K7L 5P9
    Canada

    Site Not Available

  • Credit Valley Hospital

    Missisauga, Ontario L5M 2N1
    Canada

    Site Not Available

  • Southlake Regional Health Centre

    Newmarket, Ontario L3Y 2P9
    Canada

    Site Not Available

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario K1H 1C4
    Canada

    Site Not Available

  • Peterborough Regional Health Centre

    Peterborough, Ontario K9H 7B6
    Canada

    Site Not Available

  • Group Health Centre

    Sault Saint Marie, Ontario P6A 2C4
    Canada

    Site Not Available

  • Group Health Centre

    Sault St. Marie, Ontario P6A 2C4
    Canada

    Site Not Available

  • Hotel Dieu Health Sciences Hospital

    St. Catherines, Ontario L2R 5K3
    Canada

    Site Not Available

  • Northeastern Ontario Regional Cancer Centre

    Sudbury, Ontario P3E 5J1
    Canada

    Site Not Available

  • Mount Sinai Hospital

    Toronto, Ontario M5G 1X5
    Canada

    Site Not Available

  • Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Toronto East General Hospital

    Toronto, Ontario M4C 3E7
    Canada

    Site Not Available

  • Toronto-Sunnybrook Reg.Canc.Center

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Humbar River Regional Hospital

    Weston, Ontario M9N 1N8
    Canada

    Site Not Available

  • Hopital Du Sacre - Coeur De Montreal

    Montreal, Quebec H4J 1C5
    Canada

    Site Not Available

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec H2L 4M1
    Canada

    Site Not Available

  • McGill University

    Montreal, Quebec H2W 1S6
    Canada

    Site Not Available

  • Hopital Laval

    Ste-Foy, Quebec G1V 4G5
    Canada

    Site Not Available

  • Allan Blair Cancer Centre

    Regina, Saskatchewan S4T 7T1
    Canada

    Site Not Available

  • Institution: Clinica Las Condes

    Santiago,
    Chile

    Site Not Available

  • Pamela Youde Nethersole Easter Hospital

    Hong Kong,
    China

    Site Not Available

  • Queen Mary Hospital

    Hong Kong,
    China

    Site Not Available

  • Lungenklinik Heckeshorn

    Berlin, 14109
    Germany

    Site Not Available

  • Asklepios Fachkiniken

    Gauting, 82131
    Germany

    Site Not Available

  • Zentrum fur pheulmologie und Thoraxchirurgie

    Grosshansdorf, 22927
    Germany

    Site Not Available

  • Thoraxklinik Heidelberg

    Heidelberg, 69126
    Germany

    Site Not Available

  • Lungenklinik Hermer

    Hermer, 58675
    Germany

    Site Not Available

  • Sotiria Hospital

    Athens, 115 27
    Greece

    Site Not Available

  • Haemek Medical Center

    Afula, 18101
    Israel

    Site Not Available

  • RAMBAM Medical Center

    Haifa,
    Israel

    Site Not Available

  • Rabin Medical Center Beilinson Campus

    Petach-Tiqva, 49100
    Israel

    Site Not Available

  • Rabin Medical Center Golda Campus

    Petach-Tiqva, 49372
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rehovot,
    Israel

    Site Not Available

  • Sourasky Medical Center Oncology Institute

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Sheba Medical Center Oncology Day Care

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • Assaf Harofeh Medical Center

    Zerifin, 70300
    Israel

    Site Not Available

  • Instituto Nacional de Cancerologia

    Mexico City, CP 14000
    Mexico

    Site Not Available

  • Centro Estatal de Cancerologia de Durango

    Durango,
    Mexico

    Site Not Available

  • Hospital Central Sur de Alta Especialidad, PEMEX

    Mexico City,
    Mexico

    Site Not Available

  • Wellington Hospital

    Riddiford Street, Wellington
    New Zealand

    Site Not Available

  • Greenlane Hospital - New Zealand

    Auckland 3,
    New Zealand

    Site Not Available

  • Oncology Institute Bucharest

    Bucharest,
    Romania

    Site Not Available

  • Oncology Institute Ion Chiricuta

    Cluj-Napoca, 3400
    Romania

    Site Not Available

  • Spitalul Universitar

    Iasi, 6600
    Romania

    Site Not Available

  • Clinical County Hospital

    Sibiu, 2400
    Romania

    Site Not Available

  • National Cancer Centre - Singapore

    Singapore, 169610
    Singapore

    Site Not Available

  • National University Hospital

    Singapore, 119074
    Singapore

    Site Not Available

  • Durban Oncology Centre

    Westbridge, Durban 4091
    South Africa

    Site Not Available

  • Die Wilgers Hospital

    Lynnwood, Pretoria
    South Africa

    Site Not Available

  • Oncotherapy Dept, National Hospital

    Bloemfontein, 9301
    South Africa

    Site Not Available

  • Sandton Oncology Centre

    Parklands, 2121
    South Africa

    Site Not Available

  • Johannesburg Hospital

    Parktown, 2193
    South Africa

    Site Not Available

  • Eastern Cape Oncology Centre

    Port Elizabeth, 6000
    South Africa

    Site Not Available

  • Mary Potter Oncology Centre

    Pretoria,
    South Africa

    Site Not Available

  • University of Pretoria

    Pretoria,
    South Africa

    Site Not Available

  • Rosebank Clinic Oncology Unit

    Rosebank,
    South Africa

    Site Not Available

  • Lund University Hospital

    Lund,
    Sweden

    Site Not Available

  • Sahlgrenska University Hospital

    Lund,
    Sweden

    Site Not Available

  • Pramongkutklao Hospital

    Phayathai, Bangkok 10400
    Thailand

    Site Not Available

  • Div. of Med Onc. The National Cancer Institute of Thailand

    Bangkok, 10400
    Thailand

    Site Not Available

  • Chiangmai University

    Chiangmai, 50002
    Thailand

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98109
    United States

    Site Not Available

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