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Brief Title: OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Official Title: A Randomized Placebo Controlled Study of OSI-774 (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
Study ID: NCT00036647
Brief 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Chicago Medical Center, Chicago, Illinois, United States
University of Washington, Seattle, Washington, United States
Centro Medico Confidence, Buenos Aires, CP, Argentina
Hospital Britanico, Buenos Aires, , Argentina
Hospital Interzonal de Agudos Evita, Buenos Aires, , Argentina
Instituto Alexander fleming, Buenos Aires, , Argentina
Hospital Churruca Visca, Buenos Aires, , Argentina
Instituto Oncologico Angel Roffo, Capital Federal, , Argentina
Hospital Italiano, Capital Federal, , Argentina
Canberra Hospital- Australia, Woden, Australian Capital Territory, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Newcastle Mater Misericordiae Hospital, Waratah, New South Wales, Australia
Southern Medical Day Care Center, Wollongong, New South Wales, Australia
Western Hospital, Footscray, Victoria, Australia
The Royal Melbourne Hospital, Parkville, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Royal Adelaide Hospital, South Australia, , Australia
Peter MacCallum Cancer Institute, Victoria, , Australia
Austin & Repatriation Medical Centre, Victoria, , Australia
Nucleo de Oncologia da Bahia, Salvador, Bahia, Brazil
Instituto do Cancer do Ceara, Fortaleza, CEP, Brazil
Instituto Nacional de Cancerologia, Rio De Janeiro, CEP, Brazil
Hospital Vera Cruz S/A, Belo Horizonte, Mg Cep, Brazil
Irmandade Santa Casa de Miseicordia de Porto, Porto Alegre, Rs Cep, Brazil
Hospital Sao Lucas da PUCRS, Porto Alegre, Rs Cep, Brazil
Faculdade de Medicina do ABC, Santo Andre, Sp Cep, Brazil
Escola Paulista de Medicina, Sao Paulo, Sp Cep, Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho, Sao Paulo, SP, Brazil
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Cancer Centre for the Southern Interior, Kelowna, British Columbia, Canada
BCCA - Vancouver Island, Victoria, British Columbia, Canada
CancerCare Manitoba (CCMB), Winnipeg, Manitoba, Canada
Dr.H. Bliss Murphy Cancer Centre, St. John's, Newfoundland and Labrador, Canada
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
The Royal Victoria Hospital, Barrie, Ontario, Canada
Hamilton Regional Cancer Centre, Hamilton, Ontario, Canada
Kingston Regional Cancer Centre, Kingston, Ontario, Canada
Credit Valley Hospital, Missisauga, Ontario, Canada
Southlake Regional Health Centre, Newmarket, Ontario, Canada
Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada
Peterborough Regional Health Centre, Peterborough, Ontario, Canada
Group Health Centre, Sault Saint Marie, Ontario, Canada
Hotel Dieu Health Sciences Hospital, St. Catherines, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury, Ontario, Canada
Toronto East General Hospital, Toronto, Ontario, Canada
Toronto-Sunnybrook Reg.Canc.Center, Toronto, Ontario, Canada
Mount Sinai Hospital, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Humbar River Regional Hospital, Weston, Ontario, Canada
Hopital Notre-Dame du CHUM, Montreal, Quebec, Canada
McGill University, Montreal, Quebec, Canada
Hopital Du Sacre - Coeur De Montreal, Montreal, Quebec, Canada
Hopital Laval, Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Institution: Clinica Las Condes, Santiago, , Chile
Pamela Youde Nethersole Easter Hospital, Hong Kong, , China
Queen Mary Hospital, Hong Kong, , China
Lungenklinik Heckeshorn, Berlin, , Germany
Asklepios Fachkiniken, Gauting, , Germany
Zentrum fur pheulmologie und Thoraxchirurgie, Grosshansdorf, , Germany
Thoraxklinik Heidelberg, Heidelberg, , Germany
Lungenklinik Hermer, Hermer, , Germany
Sotiria Hospital, Athens, , Greece
Haemek Medical Center, Afula, , Israel
RAMBAM Medical Center, Haifa, , Israel
Rabin Medical Center Beilinson Campus, Petach-Tiqva, , Israel
Rabin Medical Center Golda Campus, Petach-Tiqva, , Israel
Kaplan Medical Center, Rehovot, , Israel
Sourasky Medical Center Oncology Institute, Tel Aviv, , Israel
Sheba Medical Center Oncology Day Care, Tel Hashomer, , Israel
Assaf Harofeh Medical Center, Zerifin, , Israel
Instituto Nacional de Cancerologia, Mexico City, CP, Mexico
Centro Estatal de Cancerologia de Durango, Durango, , Mexico
Hospital Central Sur de Alta Especialidad, PEMEX, Mexico City, , Mexico
Wellington Hospital, Riddiford Street, Wellington, New Zealand
Greenlane Hospital - New Zealand, Auckland 3, , New Zealand
Oncology Institute Bucharest, Bucharest, , Romania
Oncology Institute Ion Chiricuta, Cluj-Napoca, , Romania
Spitalul Universitar, Iasi, , Romania
Clinical County Hospital, Sibiu, , Romania
National University Hospital, Singapore, , Singapore
National Cancer Centre - Singapore, Singapore, , Singapore
Durban Oncology Centre, Westbridge, Durban, South Africa
Die Wilgers Hospital, Lynnwood, Pretoria, South Africa
Oncotherapy Dept, National Hospital, Bloemfontein, , South Africa
Sandton Oncology Centre, Parklands, , South Africa
Johannesburg Hospital, Parktown, , South Africa
Eastern Cape Oncology Centre, Port Elizabeth, , South Africa
Mary Potter Oncology Centre, Pretoria, , South Africa
University of Pretoria, Pretoria, , South Africa
Rosebank Clinic Oncology Unit, Rosebank, , South Africa
Lund University Hospital, Lund, , Sweden
Sahlgrenska University Hospital, Lund, , Sweden
Pramongkutklao Hospital, Phayathai, Bangkok, Thailand
Div. of Med Onc. The National Cancer Institute of Thailand, Bangkok, , Thailand
Chiangmai University, Chiangmai, , Thailand
Name: Frances Shephard, M.D.
Affiliation: Princess Margaret Hospital, Canada
Role: PRINCIPAL_INVESTIGATOR