Clinical trial NCT00256711: Phase II Iressa Versus Vinorelbine (INVITE)
Official title: A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Metastatic (Stage IV) NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small-Cell Lung Carcinoma
Keywords: Locally advanced or metastatic NSCLC.
Stage IIIb or Stage IV lung cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-22
Enrollment: 192
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, open label, parallel group, multi-centre, phase II study of progression free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed NSCLC and willing to provide paraffin embedded tumour tissue
* NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy chemonaïve, life expectancy of 12 weeks
* WHO Performance status \<= 2

Exclusion Criteria:

* Newly diagnosed CNS metastases
* Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity.
* Hypersensitivity to ZD1839 or intravenous vinorelbine
* Prior treatment with EGFR inhibitors
* Other co-existing malignancies
* ALT/AST \>2.5 x ULRR
* ANC \< 2.0 x 10\^9/L or platelets \< 100 x 10\^9/L

Primary outcomes:
measure: To compare ZD1839 and vinorelbine in terms of progression free survival
Secondary outcomes:
measure: To compare ZD1839 and vinorelbine in terms of pulmonary symptom improvement weekly for 18 weeks.
measure: To compare ZD1839 and vinorelbine in terms of quality of life 3 weekly for 18 weeks then 6 weekly.
measure: To compare ZD1839 and vinorelbine in terms of adverse event profile continuous monitoring.
measure: To compare ZD1839 and vinorelbine in terms of overall objective tumour response rate (complete response and partial response) 6 weekly to progression.
measure: To compare ZD1839 and vinorelbine in terms of overall survival (time to death) continuous monitoring
Other outcomes:
Locations:
city: St. Leonards
country: Australia
facility: Research Site
state: New South Wales
city: Westmead
country: Australia
facility: Research Site
state: New South Wales
city: South Brisbane
country: Australia
facility: Research Site
state: Queensland
city: Nedlands
country: Australia
facility: Research Site
state: Western Australia
city: Victoria
country: Australia
facility: Research Site
city: Fortaleza
country: Brazil
facility: Research Site
state: CE
city: Goiania
country: Brazil
facility: Research Site
state: GO
city: Rio de Janeiro
country: Brazil
facility: Research Site
state: RJ
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
city: Praha 8
country: Czech Republic
facility: Research Site
state: CZ
city: Usti nad Labem
country: Czech Republic
facility: Research Site
state: CZ
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Kutná Hora
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Ostrava - Poruba
country: Czech Republic
facility: Research Site
city: Ostrava
country: Czech Republic
facility: Research Site
city: Plzen
country: Czech Republic
facility: Research Site
city: Marseille Cedex 09
country: France
facility: Research Site
city: Montpellier Cedex 5
country: France
facility: Research Site
city: Montpellier Cedex
country: France
facility: Research Site
city: Pierre Benite Cedex
country: France
facility: Research Site
city: Vesoul Cedex
country: France
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
state: Baden-Württemberg
city: Ulm
country: Germany
facility: Research Site
state: Baden-Württemberg
city: München
country: Germany
facility: Research Site
state: Bayern
city: Magdeburg
country: Germany
facility: Research Site
state: Sachsen-Anhalt
city: Bad Segeberg
country: Germany
facility: Research Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Research Site
city: Großhansdorf
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: La Torretta
country: Italy
facility: Research Site
state: Ancona
city: Bergamo
country: Italy
facility: Research Site
state: BG
city: Bologna
country: Italy
facility: Research Site
state: BO
city: Catania
country: Italy
facility: Research Site
state: CT
city: Melegnano
country: Italy
facility: Research Site
state: MI
city: Milano
country: Italy
facility: Research Site
state: MI
city: Rozzano
country: Italy
facility: Research Site
state: MI
city: Modena
country: Italy
facility: Research Site
state: MO
city: Parma
country: Italy
facility: Research Site
state: PR
city: Orbassano
country: Italy
facility: Research Site
state: TO
city: Torino
country: Italy
facility: Research Site
state: TO
city: Napoli
country: Italy
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
state: Cambrideshire
city: Birmingham
country: United Kingdom
facility: Research Site
state: West Midlands
city: Aberdeen
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Iressa Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Crino L, Cappuzzo F, Zatloukal P, Reck M, Pesek M, Thompson JC, Ford HE, Hirsch FR, Varella-Garcia M, Ghiorghiu S, Duffield EL, Armour AA, Speake G, Cullen M. Gefitinib versus vinorelbine in chemotherapy-naive elderly patients with advanced non-small-cell lung cancer (INVITE): a randomized, phase II study. J Clin Oncol. 2008 Sep 10;26(26):4253-60. doi: 10.1200/JCO.2007.15.0672.