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

NCT ID: NCT00036647

Last Updated: 2018-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

731 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-01

Study Completion Date

2004-01-30

Brief Summary

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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

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Conditions

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Carcinoma, Non-small-cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tarceva (erlotinib HCl, OSI-774 )

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* If the patient received radiation therapy, treatment was at least 4 weeks ago.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Cancer Trials Group

NETWORK

Sponsor Role collaborator

OSI Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Frances Shephard, M.D.

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

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University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Centro Medico Confidence

Buenos Aires, CP, Argentina

Site Status

Hospital Britanico

Buenos Aires, , Argentina

Site Status

Hospital Interzonal de Agudos Evita

Buenos Aires, , Argentina

Site Status

Instituto Alexander fleming

Buenos Aires, , Argentina

Site Status

Hospital Churruca Visca

Buenos Aires, , Argentina

Site Status

Instituto Oncologico Angel Roffo

Capital Federal, , Argentina

Site Status

Hospital Italiano

Capital Federal, , Argentina

Site Status

Canberra Hospital- Australia

Woden, Australian Capital Territory, Australia

Site Status

Prince of Wales Hospital

Randwick, New South Wales, Australia

Site Status

Newcastle Mater Misericordiae Hospital

Waratah, New South Wales, Australia

Site Status

Southern Medical Day Care Center

Wollongong, New South Wales, Australia

Site Status

Western Hospital

Footscray, Victoria, Australia

Site Status

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Site Status

Royal Adelaide Hospital

South Australia, , Australia

Site Status

Peter MacCallum Cancer Institute

Victoria, , Australia

Site Status

Austin & Repatriation Medical Centre

Victoria, , Australia

Site Status

Instituto do Cancer do Ceara

Fortaleza, CEP, Brazil

Site Status

Instituto Nacional de Cancerologia

Rio de Janeiro, CEP, Brazil

Site Status

Nucleo de Oncologia da Bahia

Salvador, Estado de Bahia, Brazil

Site Status

Hospital Vera Cruz S/A

Belo Horizonte, MG CEP, Brazil

Site Status

Irmandade Santa Casa de Miseicordia de Porto

Porto Alegre, RS CEP, Brazil

Site Status

Hospital Sao Lucas da PUCRS

Porto Alegre, RS CEP, Brazil

Site Status

Faculdade de Medicina do ABC

Santo André, SP CEP, Brazil

Site Status

Escola Paulista de Medicina

São Paulo, SP CEP, Brazil

Site Status

Instituto do Cancer Arnaldo Vieira de Carvalho

São Paulo, São Paulo, Brazil

Site Status

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

Cancer Centre for the Southern Interior

Kelowna, British Columbia, Canada

Site Status

BCCA - Vancouver Island

Victoria, British Columbia, Canada

Site Status

CancerCare Manitoba (CCMB)

Winnipeg, Manitoba, Canada

Site Status

Dr.H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, Canada

Site Status

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

The Royal Victoria Hospital

Barrie, Ontario, Canada

Site Status

Northeastern Ontario Regional Cancer Centre

Greater Sudbury, Ontario, Canada

Site Status

Hamilton Regional Cancer Centre

Hamilton, Ontario, Canada

Site Status

Kingston Regional Cancer Centre

Kingston, Ontario, Canada

Site Status

Credit Valley Hospital

Missisauga, Ontario, Canada

Site Status

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Site Status

Ottawa Regional Cancer Centre

Ottawa, Ontario, Canada

Site Status

Peterborough Regional Health Centre

Peterborough, Ontario, Canada

Site Status

Hotel Dieu Health Sciences Hospital

Saint Catherines, Ontario, Canada

Site Status

Group Health Centre

Sault Saint Marie, Ontario, Canada

Site Status

Toronto East General Hospital

Toronto, Ontario, Canada

Site Status

Toronto-Sunnybrook Reg.Canc.Center

Toronto, Ontario, Canada

Site Status

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Humbar River Regional Hospital

Weston, Ontario, Canada

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Hopital Notre-Dame du CHUM

Montreal, Quebec, Canada

Site Status

McGill University

Montreal, Quebec, Canada

Site Status

Hopital Du Sacre - Coeur De Montreal

Montreal, Quebec, Canada

Site Status

Hopital Laval

Ste-Foy, Quebec, Canada

Site Status

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Site Status

Institution: Clinica Las Condes

Santiago, , Chile

Site Status

Pamela Youde Nethersole Easter Hospital

Hong Kong, , China

Site Status

Queen Mary Hospital

Hong Kong, , China

Site Status

Lungenklinik Heckeshorn

Berlin, , Germany

Site Status

Asklepios Fachkiniken

Gauting, , Germany

Site Status

Zentrum fur pheulmologie und Thoraxchirurgie

Großhansdorf, , Germany

Site Status

Thoraxklinik Heidelberg

Heidelberg, , Germany

Site Status

Lungenklinik Hermer

Hermer, , Germany

Site Status

Sotiria Hospital

Athens, , Greece

Site Status

Haemek Medical Center

Afula, , Israel

Site Status

RAMBAM Medical Center

Haifa, , Israel

Site Status

Rabin Medical Center Beilinson Campus

Petach-Tiqva, , Israel

Site Status

Rabin Medical Center Golda Campus

Petach-Tiqva, , Israel

Site Status

Kaplan Medical Center

Rehovot, , Israel

Site Status

Sourasky Medical Center Oncology Institute

Tel Aviv, , Israel

Site Status

Sheba Medical Center Oncology Day Care

Tel Litwinsky, , Israel

Site Status

Assaf Harofeh Medical Center

Ẕerifin, , Israel

Site Status

Instituto Nacional de Cancerologia

Mexico City, CP, Mexico

Site Status

Centro Estatal de Cancerologia de Durango

Durango, , Mexico

Site Status

Hospital Central Sur de Alta Especialidad, PEMEX

Mexico City, , Mexico

Site Status

Wellington Hospital

Riddiford Street, Wellington Region, New Zealand

Site Status

Greenlane Hospital - New Zealand

Auckland, , New Zealand

Site Status

Oncology Institute Bucharest

Bucharest, , Romania

Site Status

Oncology Institute Ion Chiricuta

Cluj-Napoca, , Romania

Site Status

Spitalul Universitar

Iași, , Romania

Site Status

Clinical County Hospital

Sibiu, , Romania

Site Status

National University Hospital

Singapore, , Singapore

Site Status

National Cancer Centre - Singapore

Singapore, , Singapore

Site Status

Durban Oncology Centre

Westbridge, Durban, South Africa

Site Status

Die Wilgers Hospital

Lynnwood, Pretoria, South Africa

Site Status

Oncotherapy Dept, National Hospital

Bloemfontein, , South Africa

Site Status

Sandton Oncology Centre

Parklands, , South Africa

Site Status

Johannesburg Hospital

Parktown, , South Africa

Site Status

Eastern Cape Oncology Centre

Port Elizabeth, , South Africa

Site Status

Mary Potter Oncology Centre

Pretoria, , South Africa

Site Status

University of Pretoria

Pretoria, , South Africa

Site Status

Rosebank Clinic Oncology Unit

Rosebank, , South Africa

Site Status

Lund University Hospital

Lund, , Sweden

Site Status

Sahlgrenska University Hospital

Lund, , Sweden

Site Status

Pramongkutklao Hospital

Phayathai, Bangkok, Thailand

Site Status

Div. of Med Onc. The National Cancer Institute of Thailand

Bangkok, , Thailand

Site Status

Chiangmai University

Chiang Mai, , Thailand

Site Status

Countries

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United States Argentina Australia Brazil Canada Chile China Germany Greece Israel Mexico New Zealand Romania Singapore South Africa Sweden Thailand

References

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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.

Reference Type BACKGROUND
PMID: 16014882 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16014883 (View on PubMed)

Related Links

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https://astellasclinicalstudyresults.com/study.aspx?ID=63

Link to results on Astellas Clinical Study Results website

Other Identifiers

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BR.21

Identifier Type: -

Identifier Source: org_study_id

NCT00026325

Identifier Type: -

Identifier Source: nct_alias

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