Back to resultsOSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Primary Purpose
Carcinoma, Non-small-cell Lung
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tarceva (erlotinib HCl, OSI-774 )
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-small-cell Lung focused on measuring Non-Small Cell Lung Cancer, Tarceva, EGFR, erlotinib
Eligibility 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.
Sites / Locations
- University of Chicago Medical Center
- University of Washington
- Centro Medico Confidence
- Hospital Britanico
- Hospital Interzonal de Agudos Evita
- Instituto Alexander fleming
- Hospital Churruca Visca
- Instituto Oncologico Angel Roffo
- Hospital Italiano
- Canberra Hospital- Australia
- Prince of Wales Hospital
- Newcastle Mater Misericordiae Hospital
- Southern Medical Day Care Center
- Western Hospital
- The Royal Melbourne Hospital
- Sir Charles Gairdner Hospital
- Royal Adelaide Hospital
- Peter MacCallum Cancer Institute
- Austin & Repatriation Medical Centre
- Nucleo de Oncologia da Bahia
- Instituto do Cancer do Ceara
- Instituto Nacional de Cancerologia
- Hospital Vera Cruz S/A
- Irmandade Santa Casa de Miseicordia de Porto
- Hospital Sao Lucas da PUCRS
- Faculdade de Medicina do ABC
- Escola Paulista de Medicina
- Instituto do Cancer Arnaldo Vieira de Carvalho
- Tom Baker Cancer Centre
- Cross Cancer Institute
- Cancer Centre for the Southern Interior
- BCCA - Vancouver Island
- CancerCare Manitoba (CCMB)
- Dr.H. Bliss Murphy Cancer Centre
- QEII Health Sciences Centre
- The Royal Victoria Hospital
- Hamilton Regional Cancer Centre
- Kingston Regional Cancer Centre
- Credit Valley Hospital
- Southlake Regional Health Centre
- Ottawa Regional Cancer Centre
- Peterborough Regional Health Centre
- Group Health Centre
- Hotel Dieu Health Sciences Hospital
- Northeastern Ontario Regional Cancer Centre
- Toronto East General Hospital
- Toronto-Sunnybrook Reg.Canc.Center
- Mount Sinai Hospital
- Princess Margaret Hospital
- Humbar River Regional Hospital
- Hopital Notre-Dame du CHUM
- McGill University
- Hopital Du Sacre - Coeur De Montreal
- Hopital Laval
- Allan Blair Cancer Centre
- Institution: Clinica Las Condes
- Pamela Youde Nethersole Easter Hospital
- Queen Mary Hospital
- Lungenklinik Heckeshorn
- Asklepios Fachkiniken
- Zentrum fur pheulmologie und Thoraxchirurgie
- Thoraxklinik Heidelberg
- Lungenklinik Hermer
- Sotiria Hospital
- Haemek Medical Center
- RAMBAM Medical Center
- Rabin Medical Center Beilinson Campus
- Rabin Medical Center Golda Campus
- Kaplan Medical Center
- Sourasky Medical Center Oncology Institute
- Sheba Medical Center Oncology Day Care
- Assaf Harofeh Medical Center
- Instituto Nacional de Cancerologia
- Centro Estatal de Cancerologia de Durango
- Hospital Central Sur de Alta Especialidad, PEMEX
- Wellington Hospital
- Greenlane Hospital - New Zealand
- Oncology Institute Bucharest
- Oncology Institute Ion Chiricuta
- Spitalul Universitar
- Clinical County Hospital
- National University Hospital
- National Cancer Centre - Singapore
- Durban Oncology Centre
- Die Wilgers Hospital
- Oncotherapy Dept, National Hospital
- Sandton Oncology Centre
- Johannesburg Hospital
- Eastern Cape Oncology Centre
- Mary Potter Oncology Centre
- University of Pretoria
- Rosebank Clinic Oncology Unit
- Lund University Hospital
- Sahlgrenska University Hospital
- Pramongkutklao Hospital
- Div. of Med Onc. The National Cancer Institute of Thailand
- Chiangmai University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00036647
First Posted
May 13, 2002
Last Updated
January 8, 2018
Sponsor
OSI Pharmaceuticals
Collaborators
Canadian Cancer Trials Group
1. Study Identification
Unique Protocol Identification Number
NCT00036647
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 Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 1, 2001 (Actual)
Primary Completion Date
January 30, 2004 (Actual)
Study Completion Date
January 30, 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
OSI Pharmaceuticals
Collaborators
Canadian Cancer Trials Group
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-small-cell Lung
Keywords
Non-Small Cell Lung Cancer, Tarceva, EGFR, erlotinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
731 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tarceva (erlotinib HCl, OSI-774 )
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances Shephard, M.D.
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Centro Medico Confidence
City
Buenos Aires
State/Province
CP
ZIP/Postal Code
1642
Country
Argentina
Facility Name
Hospital Britanico
City
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Hospital Interzonal de Agudos Evita
City
Buenos Aires
ZIP/Postal Code
B1824
Country
Argentina
Facility Name
Instituto Alexander fleming
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
Hospital Churruca Visca
City
Buenos Aires
ZIP/Postal Code
C1427
Country
Argentina
Facility Name
Instituto Oncologico Angel Roffo
City
Capital Federal
ZIP/Postal Code
CP1417
Country
Argentina
Facility Name
Hospital Italiano
City
Capital Federal
Country
Argentina
Facility Name
Canberra Hospital- Australia
City
Woden
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Newcastle Mater Misericordiae Hospital
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2289
Country
Australia
Facility Name
Southern Medical Day Care Center
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Western Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Adelaide Hospital
City
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Peter MacCallum Cancer Institute
City
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Austin & Repatriation Medical Centre
City
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Nucleo de Oncologia da Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40170-070
Country
Brazil
Facility Name
Instituto do Cancer do Ceara
City
Fortaleza
State/Province
CEP
ZIP/Postal Code
60430-230
Country
Brazil
Facility Name
Instituto Nacional de Cancerologia
City
Rio De Janeiro
State/Province
CEP
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Hospital Vera Cruz S/A
City
Belo Horizonte
State/Province
Mg Cep
ZIP/Postal Code
30190-130
Country
Brazil
Facility Name
Irmandade Santa Casa de Miseicordia de Porto
City
Porto Alegre
State/Province
Rs Cep
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Hospital Sao Lucas da PUCRS
City
Porto Alegre
State/Province
Rs Cep
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Faculdade de Medicina do ABC
City
Santo Andre
State/Province
Sp Cep
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Escola Paulista de Medicina
City
Sao Paulo
State/Province
Sp Cep
ZIP/Postal Code
040039-032
Country
Brazil
Facility Name
Instituto do Cancer Arnaldo Vieira de Carvalho
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01224-010
Country
Brazil
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Cancer Centre for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
BCCA - Vancouver Island
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
CancerCare Manitoba (CCMB)
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Dr.H. Bliss Murphy Cancer Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
The Royal Victoria Hospital
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Hamilton Regional Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L9V 5C2
Country
Canada
Facility Name
Kingston Regional Cancer Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Credit Valley Hospital
City
Missisauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Peterborough Regional Health Centre
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 7B6
Country
Canada
Facility Name
Group Health Centre
City
Sault Saint Marie
State/Province
Ontario
ZIP/Postal Code
P6A 2C4
Country
Canada
Facility Name
Hotel Dieu Health Sciences Hospital
City
St. Catherines
State/Province
Ontario
ZIP/Postal Code
L2R 5K3
Country
Canada
Facility Name
Northeastern Ontario Regional Cancer Centre
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Toronto East General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
Facility Name
Toronto-Sunnybrook Reg.Canc.Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Humbar River Regional Hospital
City
Weston
State/Province
Ontario
ZIP/Postal Code
M9N 1N8
Country
Canada
Facility Name
Hopital Notre-Dame du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Hopital Du Sacre - Coeur De Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Hopital Laval
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
Institution: Clinica Las Condes
City
Santiago
Country
Chile
Facility Name
Pamela Youde Nethersole Easter Hospital
City
Hong Kong
Country
China
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Facility Name
Lungenklinik Heckeshorn
City
Berlin
ZIP/Postal Code
14109
Country
Germany
Facility Name
Asklepios Fachkiniken
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Zentrum fur pheulmologie und Thoraxchirurgie
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Thoraxklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Lungenklinik Hermer
City
Hermer
ZIP/Postal Code
58675
Country
Germany
Facility Name
Sotiria Hospital
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Haemek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
RAMBAM Medical Center
City
Haifa
Country
Israel
Facility Name
Rabin Medical Center Beilinson Campus
City
Petach-Tiqva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Rabin Medical Center Golda Campus
City
Petach-Tiqva
ZIP/Postal Code
49372
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
Country
Israel
Facility Name
Sourasky Medical Center Oncology Institute
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Sheba Medical Center Oncology Day Care
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Instituto Nacional de Cancerologia
City
Mexico City
State/Province
CP
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Centro Estatal de Cancerologia de Durango
City
Durango
Country
Mexico
Facility Name
Hospital Central Sur de Alta Especialidad, PEMEX
City
Mexico City
Country
Mexico
Facility Name
Wellington Hospital
City
Riddiford Street
State/Province
Wellington
Country
New Zealand
Facility Name
Greenlane Hospital - New Zealand
City
Auckland 3
Country
New Zealand
Facility Name
Oncology Institute Bucharest
City
Bucharest
Country
Romania
Facility Name
Oncology Institute Ion Chiricuta
City
Cluj-Napoca
ZIP/Postal Code
3400
Country
Romania
Facility Name
Spitalul Universitar
City
Iasi
ZIP/Postal Code
6600
Country
Romania
Facility Name
Clinical County Hospital
City
Sibiu
ZIP/Postal Code
2400
Country
Romania
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National Cancer Centre - Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Durban Oncology Centre
City
Westbridge
State/Province
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Die Wilgers Hospital
City
Lynnwood
State/Province
Pretoria
Country
South Africa
Facility Name
Oncotherapy Dept, National Hospital
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Sandton Oncology Centre
City
Parklands
ZIP/Postal Code
2121
Country
South Africa
Facility Name
Johannesburg Hospital
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Eastern Cape Oncology Centre
City
Port Elizabeth
ZIP/Postal Code
6000
Country
South Africa
Facility Name
Mary Potter Oncology Centre
City
Pretoria
Country
South Africa
Facility Name
University of Pretoria
City
Pretoria
Country
South Africa
Facility Name
Rosebank Clinic Oncology Unit
City
Rosebank
Country
South Africa
Facility Name
Lund University Hospital
City
Lund
Country
Sweden
Facility Name
Sahlgrenska University Hospital
City
Lund
Country
Sweden
Facility Name
Pramongkutklao Hospital
City
Phayathai
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Div. of Med Onc. The National Cancer Institute of Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Chiangmai University
City
Chiangmai
ZIP/Postal Code
50002
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
16014882
Citation
Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.
Results Reference
background
PubMed Identifier
16014883
Citation
Tsao MS, Sakurada A, Cutz JC, Zhu CQ, Kamel-Reid S, Squire J, Lorimer I, Zhang T, Liu N, Daneshmand M, Marrano P, da Cunha Santos G, Lagarde A, Richardson F, Seymour L, Whitehead M, Ding K, Pater J, Shepherd FA. Erlotinib in lung cancer - molecular and clinical predictors of outcome. N Engl J Med. 2005 Jul 14;353(2):133-44. doi: 10.1056/NEJMoa050736. Erratum In: N Engl J Med. 2006 Oct 19;355(16):1746.
Results Reference
background
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=63
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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