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| Sponsor: | OSI Pharmaceuticals |
|---|---|
| Collaborator: |
NCIC Clinical Trials Group |
| Information provided by: | OSI Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00036647 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small-Cell Lung |
Drug: Tarceva (erlotinib HCl, OSI-774 ) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Placebo Controlled Study of OSI-744 (Erlotinib HCl, Tarceva[TM]) in Patients With Incurable Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
Hide Study Locations| United States, Illinois | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98109 | |
| Argentina | |
| Hospital Interzonal de Agudos Evita | |
| Buenos Aires, Argentina, B1824 | |
| Instituto Oncologico Angel Roffo | |
| Capital Federal, Argentina, CP1417 | |
| Hospital Britanico | |
| Buenos Aires, Argentina, 1280 | |
| Hospital Churruca Visca | |
| Buenos Aires, Argentina, C1427 | |
| Instituto Alexander fleming | |
| Buenos Aires, Argentina, C1426ANZ | |
| Hospital Italiano | |
| Capital Federal, Argentina | |
| Argentina, CP | |
| Centro Medico Confidence | |
| Buenos Aires, CP, Argentina, 1642 | |
| Australia | |
| Royal Adelaide Hospital | |
| South Australia, Australia, 5000 | |
| Peter MacCallum Cancer Institute | |
| Victoria, Australia, 3002 | |
| Austin & Repatriation Medical Centre | |
| Victoria, Australia, 3084 | |
| Australia, Australian Capital Territory | |
| Canberra Hospital- Australia | |
| Woden, Australian Capital Territory, Australia, 2605 | |
| Australia, New South Wales | |
| Newcastle Mater Misericordiae Hospital | |
| Waratah, New South Wales, Australia, 2289 | |
| Prince of Wales Hospital | |
| Randwick, New South Wales, Australia, 2031 | |
| Southern Medical Day Care Center | |
| Wollongong, New South Wales, Australia, 2500 | |
| Australia, Victoria | |
| The Royal Melbourne Hospital | |
| Parkville, Victoria, Australia, 3050 | |
| Western Hospital | |
| Footscray, Victoria, Australia, 3011 | |
| Australia, Western Australia | |
| Sir Charles Gairdner Hospital | |
| Nedlands, Western Australia, Australia, 6009 | |
| Brazil, Bahia | |
| Nucleo de Oncologia da Bahia | |
| Salvador, Bahia, Brazil, 40170-070 | |
| Brazil, CEP | |
| Instituto Nacional de Cancerologia | |
| Rio de Janeiro, CEP, Brazil, 20230-130 | |
| Instituto do Cancer do Ceara | |
| Fortaleza, CEP, Brazil, 60430-230 | |
| Brazil, mg CEP | |
| Hospital Vera Cruz S/A | |
| Belo Horizonte, mg CEP, Brazil, 30190-130 | |
| Brazil, RS CEP | |
| Hospital Sao Lucas da PUCRS | |
| Porto Alegre, RS CEP, Brazil, 90610-000 | |
| Irmandade Santa Casa de Miseicordia de Porto | |
| Porto Alegre, RS CEP, Brazil, 90020-090 | |
| Brazil, SP | |
| Instituto do Cancer Arnaldo Vieira de Carvalho | |
| Sao Paulo, SP, Brazil, 01224-010 | |
| Brazil, SP CEP | |
| Escola Paulista de Medicina | |
| Sao Paulo, SP CEP, Brazil, 040039-032 | |
| Faculdade de Medicina do ABC | |
| Santo Andre, SP CEP, Brazil, 09060-650 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Tom Baker Cancer Centre | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, British Columbia | |
| Cancer Centre for the Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| BCCA - Vancouver Island | |
| Victoria, British Columbia, Canada, V8R 6V5 | |
| Canada, Manitoba | |
| CancerCare Manitoba (CCMB) | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Newfoundland and Labrador | |
| Dr.H. Bliss Murphy Cancer Centre | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| QEII Health Sciences Centre | |
| Halifax, Nova Scotia, Canada, B3H 2Y9 | |
| Canada, Ontario | |
| Hotel Dieu Health Sciences Hospital | |
| St. Catherines, Ontario, Canada, L2R 5K3 | |
| Group Health Centre | |
| Sault St. Marie, Ontario, Canada, P6A 2C4 | |
| Ottawa Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 1C4 | |
| Southlake Regional Health Centre | |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| Toronto East General Hospital | |
| Toronto, Ontario, Canada, M4C 3E7 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Toronto-Sunnybrook Reg.Canc.Center | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Peterborough Regional Health Centre | |
| Peterborough, Ontario, Canada, K9H 7B6 | |
| Northeastern Ontario Regional Cancer Centre | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Mount Sinai Hospital | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Hamilton Regional Cancer Centre | |
| Hamilton, Ontario, Canada, L9V 5C2 | |
| Kingston Regional Cancer Centre | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| The Royal Victoria Hospital | |
| Barrie, Ontario, Canada, L4M 6M2 | |
| Credit Valley Hospital | |
| Missisauga, Ontario, Canada, L5M 2N1 | |
| Humbar River Regional Hospital | |
| Weston, Ontario, Canada, M9N 1N8 | |
| Canada, Quebec | |
| Hopital Laval | |
| Ste Foy, Quebec, Canada, G1V 4G5 | |
| Hopital Notre-Dame du CHUM | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Hopital Du Sacre - Coeur De Montreal | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Chile | |
| Institution: Clinica Las Condes | |
| Santiago, Chile | |
| China | |
| Pamela Youde Nethersole Easter Hospital | |
| Hong Kong, China | |
| Queen Mary Hospital | |
| Hong Kong, China | |
| Germany | |
| Thoraxklinik Heidelberg | |
| Heidelberg, Germany, 69126 | |
| Zentrum fur pheulmologie und Thoraxchirurgie | |
| Grosshansdorf, Germany, 22927 | |
| Lungenklinik Hermer | |
| Hermer, Germany, 58675 | |
| Asklepios Fachkiniken | |
| Gauting, Germany, 82131 | |
| Lungenklinik Heckeshorn | |
| Berlin, Germany, 14109 | |
| Greece | |
| Sotiria Hospital | |
| Athens, Greece, 115 27 | |
| Israel | |
| Kaplan Medical Center | |
| Rehovot, Israel | |
| Haemek Medical Center | |
| Afula, Israel, 18101 | |
| RAMBAM Medical Center | |
| Haifa, Israel | |
| Rabin Medical Center Beilinson Campus | |
| Petach-Tiqva, Israel, 49100 | |
| Rabin Medical Center Golda Campus | |
| Petach-Tiqva, Israel, 49372 | |
| Sheba Medical Center Oncology Day Care | |
| Tel Hashomer, Israel, 52621 | |
| Sourasky Medical Center Oncology Institute | |
| Tel Aviv, Israel, 64239 | |
| Assaf Harofeh Medical Center | |
| Zerifin, Israel, 70300 | |
| Mexico | |
| Hospital Central Sur de Alta Especialidad, PEMEX | |
| Mexico City, Mexico | |
| Centro Estatal de Cancerologia de Durango | |
| Durango, Mexico | |
| Mexico, CP | |
| Instituto Nacional de Cancerologia | |
| Mexico City, CP, Mexico, 14000 | |
| New Zealand | |
| Greenlane Hospital - New Zealand | |
| Auckland 3, New Zealand | |
| New Zealand, Wellington | |
| Wellington Hospital | |
| Riddiford Street, Wellington, New Zealand | |
| Romania | |
| Oncology Institute Bucharest | |
| Bucharest, Romania | |
| Clinical County Hospital | |
| Sibiu, Romania, 2400 | |
| Oncology Institute Ion Chiricuta | |
| Cluj Napoca, Romania, 3400 | |
| Spitalul Universitar | |
| Iasi, Romania, 6600 | |
| Singapore | |
| National Cancer Centre - Singapore | |
| Singapore, Singapore, 169610 | |
| National University Hospital | |
| Singapore, Singapore, 119074 | |
| South Africa | |
| Johannesburg Hospital | |
| Parktown, South Africa, 2193 | |
| Rosebank Clinic Oncology Unit | |
| Rosebank, South Africa | |
| Oncotherapy Dept, National Hospital | |
| Bloemfontein, South Africa, 9301 | |
| Eastern Cape Oncology Centre | |
| Port Elizabeth, South Africa, 6000 | |
| Mary Potter Oncology Centre | |
| Pretoria, South Africa | |
| University of Pretoria | |
| Pretoria, South Africa | |
| Sandton Oncology Centre | |
| Parklands, South Africa, 2121 | |
| South Africa, Durban | |
| Durban Oncology Centre | |
| Westbridge, Durban, South Africa, 4091 | |
| South Africa, Pretoria | |
| Die Wilgers Hospital | |
| Lynnwood, Pretoria, South Africa | |
| Sweden | |
| Sahlgrenska University Hospital | |
| Lund, Sweden | |
| Lund University Hospital | |
| Lund, Sweden | |
| Thailand | |
| Chiangmai University | |
| Chiangmai, Thailand, 50002 | |
| Div. of Med Onc. The National Cancer Institute of Thailand | |
| Bangkok, Thailand, 10400 | |
| Thailand, Bangkok | |
| Pramongkutklao Hospital | |
| Phayathai, Bangkok, Thailand, 10400 | |
| Study Chair: | Frances Shepherd, M.D. |
More Information
| Study ID Numbers: | OSI-774-BR.21 |
| Study First Received: | May 13, 2002 |
| Last Updated: | December 16, 2005 |
| ClinicalTrials.gov Identifier: | NCT00036647 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Non-Small Cell Lung Cancer Tarceva EGFR erlotinib |
|
Thoracic Neoplasms Erlotinib Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
