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

This study has been completed.
Sponsor:
Collaborator:
NCIC Clinical Trials Group
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00036647
First received: May 13, 2002
Last updated: August 6, 2012
Last verified: August 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Enrollment: 731
Study Start Date: October 2001
Study Completion Date: January 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036647

  Hide Study Locations
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
Centro Medico Confidence
Buenos Aires, CP, Argentina, 1642
Hospital Interzonal de Agudos Evita
Buenos Aires, Argentina, B1824
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
Instituto Oncologico Angel Roffo
Capital Federal, Argentina, CP1417
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
Australia
Royal Adelaide Hospital
South Australia, Australia, 5000
Peter MacCallum Cancer Institute
Victoria, Australia, 3002
Austin & Repatriation Medical Centre
Victoria, Australia, 3084
Brazil
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
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
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 St. 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
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
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
Humbar River Regional Hospital
Weston, Ontario, Canada, M9N 1N8
Canada, Quebec
Hopital Du Sacre - Coeur De Montreal
Montreal, Quebec, Canada, H4J 1C5
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
McGill University
Montreal, Quebec, Canada, H2W 1S6
Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
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
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
Greece
Sotiria Hospital
Athens, Greece, 115 27
Israel
Haemek Medical Center
Afula, Israel, 18101
RAMBAM Medical Center
Haifa, Israel
Rabin Medical Center Golda Campus
Petach-Tiqva, Israel, 49372
Rabin Medical Center Beilinson Campus
Petach-Tiqva, Israel, 49100
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
Mexico
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
Romania
Oncology Institute Bucharest
Bucharest, Romania
Oncology Institute Ion Chiricuta
Cluj-Napoca, Romania, 3400
Spitalul Universitar
Iasi, Romania, 6600
Clinical County Hospital
Sibiu, Romania, 2400
Singapore
National Cancer Centre - Singapore
Singapore, Singapore, 169610
National University Hospital
Singapore, Singapore, 119074
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
Sweden
Sahlgrenska University Hospital
Lund, Sweden
Lund University Hospital
Lund, Sweden
Thailand
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
NCIC Clinical Trials Group
Investigators
Principal Investigator: Frances Shephard, M.D. Princess Margaret Hospital, Canada
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00036647     History of Changes
Obsolete Identifiers: NCT00026325
Other Study ID Numbers: BR.21
Study First Received: May 13, 2002
Last Updated: August 6, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014