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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00036647
Recruitment Status : Completed
First Posted : May 14, 2002
Last Update Posted : January 10, 2018
Canadian Cancer Trials Group
Information provided by:
Astellas Pharma Inc

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).

Condition or disease Intervention/treatment Phase
Carcinoma, Non-small-cell Lung Drug: Tarceva (erlotinib HCl, OSI-774 ) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 731 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Actual Study Start Date : November 1, 2001
Actual Primary Completion Date : January 30, 2004
Actual Study Completion Date : January 30, 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00036647

  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
Centro Medico Confidence
Buenos Aires, CP, Argentina, 1642
Hospital Britanico
Buenos Aires, Argentina, 1280
Hospital Interzonal de Agudos Evita
Buenos Aires, Argentina, B1824
Instituto Alexander fleming
Buenos Aires, Argentina, C1426ANZ
Hospital Churruca Visca
Buenos Aires, Argentina, C1427
Instituto Oncologico Angel Roffo
Capital Federal, Argentina, CP1417
Hospital Italiano
Capital Federal, Argentina
Australia, Australian Capital Territory
Canberra Hospital- Australia
Woden, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, Australia, 2289
Southern Medical Day Care Center
Wollongong, New South Wales, Australia, 2500
Australia, Victoria
Western Hospital
Footscray, Victoria, Australia, 3011
The Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Royal Adelaide Hospital
South Australia, Australia, 5000
Peter MacCallum Cancer Institute
Victoria, Australia, 3002
Austin & Repatriation Medical Centre
Victoria, Australia, 3084
Nucleo de Oncologia da Bahia
Salvador, Bahia, Brazil, 40170-070
Instituto do Cancer do Ceara
Fortaleza, CEP, Brazil, 60430-230
Instituto Nacional de Cancerologia
Rio De Janeiro, CEP, Brazil, 20230-130
Hospital Vera Cruz S/A
Belo Horizonte, Mg Cep, Brazil, 30190-130
Irmandade Santa Casa de Miseicordia de Porto
Porto Alegre, Rs Cep, Brazil, 90020-090
Hospital Sao Lucas da PUCRS
Porto Alegre, Rs Cep, Brazil, 90610-000
Faculdade de Medicina do ABC
Santo Andre, Sp Cep, Brazil, 09060-650
Escola Paulista de Medicina
Sao Paulo, Sp Cep, Brazil, 040039-032
Instituto do Cancer Arnaldo Vieira de Carvalho
Sao Paulo, SP, Brazil, 01224-010
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
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
The Royal Victoria Hospital
Barrie, Ontario, Canada, L4M 6M2
Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L9V 5C2
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Credit Valley Hospital
Missisauga, Ontario, Canada, L5M 2N1
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Peterborough Regional Health Centre
Peterborough, Ontario, Canada, K9H 7B6
Group Health Centre
Sault Saint Marie, Ontario, Canada, P6A 2C4
Hotel Dieu Health Sciences Hospital
St. Catherines, Ontario, Canada, L2R 5K3
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Toronto-Sunnybrook Reg.Canc.Center
Toronto, Ontario, Canada, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Humbar River Regional Hospital
Weston, Ontario, Canada, M9N 1N8
Canada, Quebec
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
McGill University
Montreal, Quebec, Canada, H2W 1S6
Hopital Du Sacre - Coeur De Montreal
Montreal, Quebec, Canada, H4J 1C5
Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Institution: Clinica Las Condes
Santiago, Chile
Pamela Youde Nethersole Easter Hospital
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
Lungenklinik Heckeshorn
Berlin, Germany, 14109
Asklepios Fachkiniken
Gauting, Germany, 82131
Zentrum fur pheulmologie und Thoraxchirurgie
Grosshansdorf, Germany, 22927
Thoraxklinik Heidelberg
Heidelberg, Germany, 69126
Lungenklinik Hermer
Hermer, Germany, 58675
Sotiria Hospital
Athens, Greece, 115 27
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
Kaplan Medical Center
Rehovot, Israel
Sourasky Medical Center Oncology Institute
Tel Aviv, Israel, 64239
Sheba Medical Center Oncology Day Care
Tel Hashomer, Israel, 52621
Assaf Harofeh Medical Center
Zerifin, Israel, 70300
Instituto Nacional de Cancerologia
Mexico City, CP, Mexico, 14000
Centro Estatal de Cancerologia de Durango
Durango, Mexico
Hospital Central Sur de Alta Especialidad, PEMEX
Mexico City, Mexico
New Zealand
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, 3400
Spitalul Universitar
Iasi, Romania, 6600
Clinical County Hospital
Sibiu, Romania, 2400
National University Hospital
Singapore, Singapore, 119074
National Cancer Centre - Singapore
Singapore, Singapore, 169610
South Africa
Durban Oncology Centre
Westbridge, Durban, South Africa, 4091
Die Wilgers Hospital
Lynnwood, Pretoria, South Africa
Oncotherapy Dept, National Hospital
Bloemfontein, South Africa, 9301
Sandton Oncology Centre
Parklands, South Africa, 2121
Johannesburg Hospital
Parktown, South Africa, 2193
Eastern Cape Oncology Centre
Port Elizabeth, South Africa, 6000
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, 10400
Div. of Med Onc. The National Cancer Institute of Thailand
Bangkok, Thailand, 10400
Chiangmai University
Chiangmai, Thailand, 50002
Sponsors and Collaborators
OSI Pharmaceuticals
Canadian Cancer Trials Group
Principal Investigator: Frances Shephard, M.D. Princess Margaret Hospital, Canada

Additional Information:
Publications: Identifier: NCT00036647     History of Changes
Obsolete Identifiers: NCT00026325
Other Study ID Numbers: BR.21
First Posted: May 14, 2002    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: June 2015

Keywords provided by Astellas Pharma Inc:
Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action