Clinical trial NCT00242801: Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study
Official title: A Double Blind,Placebo Controlled,Parallel Group,Multicentre,Randomised,Phase Iii Survival Study Comparing ZD1839 (IRESSA™)(250mg Tablet) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced NSCLC Who Have Received One Or Two Prior Chemotherapy Regimens And Are Refractory Or Intolerant To Their Most Recent Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: NSCLC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-21
Enrollment: 1692
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: This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.


Eligibility criteria: Inclusion Criteria:

* · Life expectancy of at least 8 weeks.

  * Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma
  * Not suitable for chemotherapy
  * WHO Performance status 0,1, 2 or 3

Exclusion Criteria:

* Newly diagnosed CNS mets
* Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
* ALT/AST greater than 5 x upper limit of normal
* ANC less than 1.0 x 109/L or platelets less than 100 x 109/L

Primary outcomes:
measure: The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care
Secondary outcomes:
measure: · ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure
measure: · ZD1839 + BSC versus Placebo + BSC in terms of investigator assessed overall
measure: · objective tumour response (CR + PR)
measure: · ZD1839 + BSC versus Placebo + BSC in terms of tolerability
measure: · ZD1839 + BSC versus Placebo + BSC in terms of quality of life changes
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: Research Site
state: Buenos Aires
city: Bahia Blanca
country: Argentina
facility: Research Site
city: Buenos Aires
country: Argentina
facility: Research Site
city: La Plata
country: Argentina
facility: Research Site
city: Mar del Plata
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Concord
country: Australia
facility: Research Site
state: New South Wales
city: Potts Point
country: Australia
facility: Research Site
state: New South Wales
city: St. Leonards
country: Australia
facility: Research Site
state: New South Wales
city: Chermside
country: Australia
facility: Research Site
state: Queensland
city: South Brisbane
country: Australia
facility: Research Site
state: Queensland
city: Ashford
country: Australia
facility: Research Site
state: South Australia
city: Woodville
country: Australia
facility: Research Site
state: South Australia
city: Melbourne
country: Australia
facility: Research Site
state: Victoria
city: Parkville
country: Australia
facility: Research Site
state: Victoria
city: Prahran
country: Australia
facility: Research Site
state: Victoria
city: Wodonga
country: Australia
facility: Research Site
state: Victoria
city: Woodville South
country: Australia
facility: Research Site
city: Fortaleza
country: Brazil
facility: Research Site
state: CE
city: Belo Horizonte
country: Brazil
facility: Research Site
state: MG
city: Rio de Janeiro
country: Brazil
facility: Research Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Research Site
state: RS
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
city: Sorocaba
country: Brazil
facility: Research Site
state: SP
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara zagora
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Veliko Tarnovo
country: Bulgaria
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Monoton
country: Canada
facility: Research Site
state: New Brunswick
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Newmarket
country: Canada
facility: Research Site
state: Ontario
city: St. Catherines
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: York
country: Canada
facility: Research Site
state: Ontario
city: Laval
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Research Site
state: Quebec
city: Various Cities
country: Chile
facility: Research Site
city: Talinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
state: Baden-Wurttemberg
city: Heidelberg
country: Germany
facility: Research Site
state: Baden-Wurttemberg
city: Muchen
country: Germany
facility: Research Site
state: Bayern
city: Frankfurt
country: Germany
facility: Research Site
state: Hessen
city: Munster
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Bad Segeberg
country: Germany
facility: Research Site
state: Schleswig-Holstein
city: Frankfurt
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Gauting
country: Germany
facility: Research Site
city: Grobhansdorf
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Hemer
country: Germany
facility: Research Site
city: Muchen
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Heraklion
country: Greece
facility: Research Site
city: Marousi
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Deszk
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Mosdos
country: Hungary
facility: Research Site
city: Mosonmagyarovar
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Torokbalint
country: Hungary
facility: Research Site
city: Ujronafj
country: Hungary
facility: Research Site
city: Zalaegerszeg-Pozva
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: India
country: India
facility: Research Site
city: Karnataka
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Vellore
country: India
facility: Research Site
city: Dooradoyle
country: Ireland
facility: Research Site
state: Limerick
city: Beaumont Road
country: Ireland
facility: Research Site
city: Cork
country: Ireland
facility: Research Site
city: Dublin 7
country: Ireland
facility: Research Site
city: Dublin 8
country: Ireland
facility: Research Site
city: Elm Park
country: Ireland
facility: Research Site
city: Daugavpils
country: Latvia
facility: Research Site
city: Liepaja
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Nilai
country: Malaysia
facility: Research Site
city: Penang
country: Malaysia
facility: Research Site
city: Torreon
country: Mexico
facility: Research Site
state: Coahuila
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Research Site
state: Neuvo Leon
city: Merida
country: Mexico
facility: Research Site
state: Yucatan
city: Acapulco
country: Mexico
facility: Research Site
city: Durango
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Leon
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Alkmaar
country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Enschede
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Alesund
country: Norway
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Gjettum
country: Norway
facility: Research Site
city: Hamar
country: Norway
facility: Research Site
city: Haugesund
country: Norway
facility: Research Site
city: Kristiansand
country: Norway
facility: Research Site
city: Nordbyhagen
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Skien
country: Norway
facility: Research Site
city: Stavanger
country: Norway
facility: Research Site
city: Tromso
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Various Cities
country: Peru
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Pasig
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj Napoca
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Dolny Kubin
country: Slovakia
facility: Research Site
city: Jilina
country: Slovakia
facility: Research Site
city: Kojice
country: Slovakia
facility: Research Site
city: Martin
country: Slovakia
facility: Research Site
city: Michalovce
country: Slovakia
facility: Research Site
city: Nitra-Zobor
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Nove Zamky
country: Slovakia
facility: Research Site
city: Poprad - Kvetnica
country: Slovakia
facility: Research Site
city: Poprad
country: Slovakia
facility: Research Site
city: Prejov
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Vasteras
country: Sweden
facility: Research Site
state: Vastmanlands Lan
city: Goteborg
country: Sweden
facility: Research Site
city: Huddinge
country: Sweden
facility: Research Site
city: Jonkoping
country: Sweden
facility: Research Site
city: Karlstad
country: Sweden
facility: Research Site
city: Linkoping
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Pan-Chiao
country: Taiwan
facility: Research Site
state: Taipei
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Tao-Yuan
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Various Cities
country: Ukraine
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
state: Cambrideshire
city: Exeter
country: United Kingdom
facility: Research Site
state: Devon
city: Colchester
country: United Kingdom
facility: Research Site
state: Essex
city: Romford
country: United Kingdom
facility: Research Site
state: Essex
city: Gorleston
country: United Kingdom
facility: Research Site
state: Great Yarmouth
city: Fulwood
country: United Kingdom
facility: Research Site
state: Lanc
city: Norwich
country: United Kingdom
facility: Research Site
state: Norfolk
city: Nottingham
country: United Kingdom
facility: Research Site
state: Northamptonshire
city: Belfast
country: United Kingdom
facility: Research Site
state: Northern Ireland
city: Birmingham
country: United Kingdom
facility: Research Site
state: West Midlands
city: Aberdeen
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Brighton
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Essex
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Guildford
country: United Kingdom
facility: Research Site
city: Gwynedd
country: United Kingdom
facility: Research Site
city: Harrogate
country: United Kingdom
facility: Research Site
city: Huddersfield
country: United Kingdom
facility: Research Site
city: Hull
country: United Kingdom
facility: Research Site
city: Lancaster
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
city: Southampton
country: United Kingdom
facility: Research Site
city: Swansea
country: United Kingdom
facility: Research Site
city: Wolverhampton
country: United Kingdom
facility: Research Site
city: York
country: United Kingdom
facility: Research Site
city: Various Cities
country: Venezuela
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Oncology Medical Science Direction
role: STUDY_DIRECTOR
References: