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

January 8, 2018 updated by: OSI Pharmaceuticals

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

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).

Study Overview

Status

Completed

Conditions

Carcinoma, Non-small-cell Lung

Intervention / Treatment

Drug: Tarceva (erlotinib HCl, OSI-774 )

Study Type

Interventional

Enrollment (Actual)

731

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1426ANZ
    - Instituto Alexander Fleming
  - Buenos Aires, Argentina, 1280
    - Hospital Británico
  - Buenos Aires, Argentina, B1824
    - Hospital Interzonal de Agudos Evita
  - Buenos Aires, Argentina, C1427
    - Hospital Churruca Visca
  - Capital Federal, Argentina, CP1417
    - Instituto Oncologico Angel Roffo
  - Capital Federal, Argentina
    - Hospital Italiano
- CP
  - Buenos Aires, CP, Argentina, 1642
    - Centro Medico Confidence
Australia
- - South Australia, Australia, 5000
    - Royal Adelaide Hospital
  - Victoria, Australia, 3002
    - Peter Maccallum Cancer Institute
  - Victoria, Australia, 3084
    - Austin & Repatriation Medical Centre
- Australian Capital Territory
  - Woden, Australian Capital Territory, Australia, 2605
    - Canberra Hospital- Australia
- New South Wales
  - Randwick, New South Wales, Australia, 2031
    - Prince of Wales Hospital
  - Waratah, New South Wales, Australia, 2289
    - Newcastle Mater Misericordiae Hospital
  - Wollongong, New South Wales, Australia, 2500
    - Southern Medical Day Care Center
- Victoria
  - Footscray, Victoria, Australia, 3011
    - Western Hospital
  - Parkville, Victoria, Australia, 3050
    - The Royal Melbourne Hospital
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Sir Charles Gairdner Hospital
Brazil
- Bahia
  - Salvador, Bahia, Brazil, 40170-070
    - Nucleo de Oncologia da Bahia
- CEP
  - Fortaleza, CEP, Brazil, 60430-230
    - Instituto do Câncer do Ceará
  - Rio De Janeiro, CEP, Brazil, 20230-130
    - Instituto Nacional de Cancerologia
- Mg Cep
  - Belo Horizonte, Mg Cep, Brazil, 30190-130
    - Hospital Vera Cruz S/A
- Rs Cep
  - Porto Alegre, Rs Cep, Brazil, 90020-090
    - Irmandade Santa Casa de Miseicordia de Porto
  - Porto Alegre, Rs Cep, Brazil, 90610-000
    - Hospital Sao Lucas da PUCRS
- SP
  - Sao Paulo, SP, Brazil, 01224-010
    - Instituto do Cancer Arnaldo Vieira de Carvalho
- Sp Cep
  - Santo Andre, Sp Cep, Brazil, 09060-650
    - Faculdade de Medicina do ABC
  - Sao Paulo, Sp Cep, Brazil, 040039-032
    - Escola Paulista de Medicina
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Centre
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 5L3
    - Cancer Centre for the Southern Interior
  - Victoria, British Columbia, Canada, V8R 6V5
    - BCCA - Vancouver Island
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - CancerCare Manitoba (CCMB)
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    - Dr.H. Bliss Murphy Cancer Centre
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - QEII Health Sciences Centre
- Ontario
  - Barrie, Ontario, Canada, L4M 6M2
    - The Royal Victoria Hospital
  - Hamilton, Ontario, Canada, L9V 5C2
    - Hamilton Regional Cancer Centre
  - Kingston, Ontario, Canada, K7L 5P9
    - Kingston Regional Cancer Centre
  - Missisauga, Ontario, Canada, L5M 2N1
    - Credit Valley Hospital
  - Newmarket, Ontario, Canada, L3Y 2P9
    - Southlake Regional Health Centre
  - Ottawa, Ontario, Canada, K1H 1C4
    - Ottawa Regional Cancer Centre
  - Peterborough, Ontario, Canada, K9H 7B6
    - Peterborough Regional Health Centre
  - Sault Saint Marie, Ontario, Canada, P6A 2C4
    - Group Health Centre
  - St. Catherines, Ontario, Canada, L2R 5K3
    - Hotel Dieu Health Sciences Hospital
  - Sudbury, Ontario, Canada, P3E 5J1
    - Northeastern Ontario Regional Cancer Centre
  - Toronto, Ontario, Canada, M4C 3E7
    - Toronto East General Hospital
  - Toronto, Ontario, Canada, M5G 2M9
    - Princess Margaret Hospital
  - Toronto, Ontario, Canada, M5G 1X5
    - Mount Sinai Hospital
  - Toronto, Ontario, Canada, M4N 3M5
    - Toronto-Sunnybrook Reg.Canc.Center
  - Weston, Ontario, Canada, M9N 1N8
    - Humbar River Regional Hospital
- Quebec
  - Montreal, Quebec, Canada, H2W 1S6
    - McGill University
  - Montreal, Quebec, Canada, H2L 4M1
    - Hopital Notre-Dame du CHUM
  - Montreal, Quebec, Canada, H4J 1C5
    - Hopital Du Sacre - Coeur De Montreal
  - Ste-Foy, Quebec, Canada, G1V 4G5
    - Hopital Laval
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre
Chile
- - Santiago, Chile
    - Institution: Clinica Las Condes
China
- - Hong Kong, China
    - Queen Mary Hospital
  - Hong Kong, China
    - Pamela Youde Nethersole Easter Hospital
Germany
- - Berlin, Germany, 14109
    - Lungenklinik Heckeshorn
  - Gauting, Germany, 82131
    - Asklepios Fachkiniken
  - Grosshansdorf, Germany, 22927
    - Zentrum fur pheulmologie und Thoraxchirurgie
  - Heidelberg, Germany, 69126
    - Thoraxklinik Heidelberg
  - Hermer, Germany, 58675
    - Lungenklinik Hermer
Greece
- - Athens, Greece, 115 27
    - Sotiria Hospital
Israel
- - Afula, Israel, 18101
    - Haemek Medical Center
  - Haifa, Israel
    - Rambam Medical Center
  - Petach-Tiqva, Israel, 49100
    - Rabin Medical Center Beilinson Campus
  - Petach-Tiqva, Israel, 49372
    - Rabin Medical Center Golda Campus
  - Rehovot, Israel
    - Kaplan Medical Center
  - Tel Aviv, Israel, 64239
    - Sourasky Medical Center Oncology Institute
  - Tel Hashomer, Israel, 52621
    - Sheba Medical Center Oncology Day Care
  - Zerifin, Israel, 70300
    - Assaf Harofeh Medical Center
Mexico
- - Durango, Mexico
    - Centro Estatal De Cancerologia De Durango
  - Mexico City, Mexico
    - Hospital Central Sur de Alta Especialidad, PEMEX
- CP
  - Mexico City, CP, Mexico, 14000
    - Instituto Nacional de Cancerologia
New Zealand
- - Auckland 3, New Zealand
    - Greenlane Hospital - New Zealand
- Wellington
  - Riddiford Street, Wellington, New Zealand
    - Wellington Hospital
Romania
- - Bucharest, Romania
    - Oncology Institute Bucharest
  - Cluj-Napoca, Romania, 3400
    - Oncology Institute Ion Chiricuta
  - Iasi, Romania, 6600
    - Spitalul Universitar
  - Sibiu, Romania, 2400
    - Clinical county Hospital
Singapore
- - Singapore, Singapore, 119074
    - National University Hospital
  - Singapore, Singapore, 169610
    - National Cancer Centre - Singapore
South Africa
- - Bloemfontein, South Africa, 9301
    - Oncotherapy Dept, National Hospital
  - Parklands, South Africa, 2121
    - Sandton Oncology Centre
  - Parktown, South Africa, 2193
    - Johannesburg Hospital
  - Port Elizabeth, South Africa, 6000
    - Eastern Cape Oncology Centre
  - Pretoria, South Africa
    - Mary Potter Oncology Centre
  - Pretoria, South Africa
    - University of Pretoria
  - Rosebank, South Africa
    - Rosebank Clinic Oncology Unit
- Durban
  - Westbridge, Durban, South Africa, 4091
    - Durban Oncology Centre
- Pretoria
  - Lynnwood, Pretoria, South Africa
    - Die Wilgers Hospital
Sweden
- - Lund, Sweden
    - Lund University Hospital
  - Lund, Sweden
    - Sahlgrenska University Hospital
Thailand
- - Bangkok, Thailand, 10400
    - Div. of Med Onc. The National Cancer Institute of Thailand
  - Chiangmai, Thailand, 50002
    - Chiangmai University
- Bangkok
  - Phayathai, Bangkok, Thailand, 10400
    - Pramongkutklao Hospital
United States
- Illinois
  - Chicago, Illinois, United States, 60637
    - University Of Chicago Medical Center
- Washington
  - Seattle, Washington, United States, 98109
    - University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OSI Pharmaceuticals

Collaborators

Canadian Cancer Trials Group

Investigators

Principal Investigator: Frances Shephard, M.D., Princess Margaret Hospital, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Link to results on Astellas Clinical Study Results website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2001

Primary Completion (Actual)

January 30, 2004

Study Completion (Actual)

January 30, 2004

Study Registration Dates

First Submitted

May 13, 2002

First Submitted That Met QC Criteria

May 13, 2002

First Posted (Estimate)

May 14, 2002

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

BR.21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.