Clinical trial NCT00036647: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Non-small-cell Lung
Keywords: Non-Small Cell Lung Cancer
Tarceva
EGFR
erlotinib
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Canadian Cancer Trials Group
First posted: 2002-05-14
Enrollment: 731
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Buenos Aires
country: Argentina
facility: Centro Medico Confidence
state: CP
city: Buenos Aires
country: Argentina
facility: Hospital Britanico
city: Buenos Aires
country: Argentina
facility: Hospital Interzonal de Agudos Evita
city: Buenos Aires
country: Argentina
facility: Instituto Alexander fleming
city: Buenos Aires
country: Argentina
facility: Hospital Churruca Visca
city: Capital Federal
country: Argentina
facility: Instituto Oncologico Angel Roffo
city: Capital Federal
country: Argentina
facility: Hospital Italiano
city: Woden
country: Australia
facility: Canberra Hospital- Australia
state: Australian Capital Territory
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Newcastle Mater Misericordiae Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Center
state: New South Wales
city: Footscray
country: Australia
facility: Western Hospital
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: South Australia
country: Australia
facility: Royal Adelaide Hospital
city: Victoria
country: Australia
facility: Peter MacCallum Cancer Institute
city: Victoria
country: Australia
facility: Austin & Repatriation Medical Centre
city: Salvador
country: Brazil
facility: Nucleo de Oncologia da Bahia
state: Bahia
city: Fortaleza
country: Brazil
facility: Instituto do Cancer do Ceara
state: CEP
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Cancerologia
state: CEP
city: Belo Horizonte
country: Brazil
facility: Hospital Vera Cruz S/A
state: Mg Cep
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Miseicordia de Porto
state: Rs Cep
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
state: Rs Cep
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC
state: Sp Cep
city: Sao Paulo
country: Brazil
facility: Escola Paulista de Medicina
state: Sp Cep
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer Arnaldo Vieira de Carvalho
state: SP
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kelowna
country: Canada
facility: Cancer Centre for the Southern Interior
state: British Columbia
city: Victoria
country: Canada
facility: BCCA - Vancouver Island
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba (CCMB)
state: Manitoba
city: St. John's
country: Canada
facility: Dr.H. Bliss Murphy Cancer Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Barrie
country: Canada
facility: The Royal Victoria Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Regional Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston Regional Cancer Centre
state: Ontario
city: Missisauga
country: Canada
facility: Credit Valley Hospital
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre
state: Ontario
city: Peterborough
country: Canada
facility: Peterborough Regional Health Centre
state: Ontario
city: Sault Saint Marie
country: Canada
facility: Group Health Centre
state: Ontario
city: St. Catherines
country: Canada
facility: Hotel Dieu Health Sciences Hospital
state: Ontario
city: Sudbury
country: Canada
facility: Northeastern Ontario Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto-Sunnybrook Reg.Canc.Center
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Weston
country: Canada
facility: Humbar River Regional Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Notre-Dame du CHUM
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Montreal
country: Canada
facility: Hopital Du Sacre - Coeur De Montreal
state: Quebec
city: Ste-Foy
country: Canada
facility: Hopital Laval
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
city: Santiago
country: Chile
facility: Institution: Clinica Las Condes
city: Hong Kong
country: China
facility: Pamela Youde Nethersole Easter Hospital
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Berlin
country: Germany
facility: Lungenklinik Heckeshorn
city: Gauting
country: Germany
facility: Asklepios Fachkiniken
city: Grosshansdorf
country: Germany
facility: Zentrum fur pheulmologie und Thoraxchirurgie
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
city: Hermer
country: Germany
facility: Lungenklinik Hermer
city: Athens
country: Greece
facility: Sotiria Hospital
city: Afula
country: Israel
facility: Haemek Medical Center
city: Haifa
country: Israel
facility: RAMBAM Medical Center
city: Petach-Tiqva
country: Israel
facility: Rabin Medical Center Beilinson Campus
city: Petach-Tiqva
country: Israel
facility: Rabin Medical Center Golda Campus
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center Oncology Institute
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center Oncology Day Care
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerologia
state: CP
city: Durango
country: Mexico
facility: Centro Estatal de Cancerologia de Durango
city: Mexico City
country: Mexico
facility: Hospital Central Sur de Alta Especialidad, PEMEX
city: Riddiford Street
country: New Zealand
facility: Wellington Hospital
state: Wellington
city: Auckland 3
country: New Zealand
facility: Greenlane Hospital - New Zealand
city: Bucharest
country: Romania
facility: Oncology Institute Bucharest
city: Cluj-Napoca
country: Romania
facility: Oncology Institute Ion Chiricuta
city: Iasi
country: Romania
facility: Spitalul Universitar
city: Sibiu
country: Romania
facility: Clinical County Hospital
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre - Singapore
city: Westbridge
country: South Africa
facility: Durban Oncology Centre
state: Durban
city: Lynnwood
country: South Africa
facility: Die Wilgers Hospital
state: Pretoria
city: Bloemfontein
country: South Africa
facility: Oncotherapy Dept, National Hospital
city: Parklands
country: South Africa
facility: Sandton Oncology Centre
city: Parktown
country: South Africa
facility: Johannesburg Hospital
city: Port Elizabeth
country: South Africa
facility: Eastern Cape Oncology Centre
city: Pretoria
country: South Africa
facility: Mary Potter Oncology Centre
city: Pretoria
country: South Africa
facility: University of Pretoria
city: Rosebank
country: South Africa
facility: Rosebank Clinic Oncology Unit
city: Lund
country: Sweden
facility: Lund University Hospital
city: Lund
country: Sweden
facility: Sahlgrenska University Hospital
city: Phayathai
country: Thailand
facility: Pramongkutklao Hospital
state: Bangkok
city: Bangkok
country: Thailand
facility: Div. of Med Onc. The National Cancer Institute of Thailand
city: Chiangmai
country: Thailand
facility: Chiangmai University
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Frances Shephard, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.