Phase II Iressa Versus Vinorelbine (INVITE)
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
2 other identifiers
interventional
192
10 countries
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2004
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 20, 2005
CompletedFirst Posted
Study publicly available on registry
November 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedApril 23, 2009
April 1, 2009
November 20, 2005
April 22, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare ZD1839 and vinorelbine in terms of progression free survival
Secondary Outcomes (5)
To compare ZD1839 and vinorelbine in terms of pulmonary symptom improvement weekly for 18 weeks.
To compare ZD1839 and vinorelbine in terms of quality of life 3 weekly for 18 weeks then 6 weekly.
To compare ZD1839 and vinorelbine in terms of adverse event profile continuous monitoring.
To compare ZD1839 and vinorelbine in terms of overall objective tumour response rate (complete response and partial response) 6 weekly to progression.
To compare ZD1839 and vinorelbine in terms of overall survival (time to death) continuous monitoring
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (55)
Research Site
St Leonards, New South Wales, Australia
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Westmead, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Nedlands, Western Australia, Australia
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Victoria, Australia
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Fortaleza, Ceará, Brazil
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Goiânia, Goiás, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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São Paulo, São Paulo, Brazil
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Prague, CZ, Czechia
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Ústí nad Labem, CZ, Czechia
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Hradec Králové, Czechia
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Kutná Hora, Czechia
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Olomouc, Czechia
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Ostrava, Czechia
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Ostrava - Poruba, Czechia
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Pilsen, Czechia
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Marseille, France
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Montpellier, France
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Pierre-Bénite, France
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Vesoul, France
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Heidelberg, Baden-Wurttemberg, Germany
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Ulm, Baden-Wurttemberg, Germany
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München, Bavaria, Germany
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Hamburg, Hamburg, Germany
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Magdeburg, Saxony-Anhalt, Germany
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Bad Segeberg, Schleswig-Holstein, Germany
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Berlin, State of Berlin, Germany
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Großhansdorf, Germany
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Halle, Germany
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Mainz, Germany
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La Torretta, Ancona, Italy
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Bergamo, BG, Italy
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Bologna, BO, Italy
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Catania, CT, Italy
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Melegnano, MI, Italy
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Milan, MI, Italy
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Rozzano, MI, Italy
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Modena, MO, Italy
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Parma, PR, Italy
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Orbassano, TO, Italy
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Torino, TO, Italy
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Napoli, Italy
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Cape Town, South Africa
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Durban, South Africa
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Seoul, South Korea
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Taichung, Taiwan
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Taipei, Taiwan
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Cambridge, Cambrideshire, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Aberdeen, United Kingdom
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Dundee, United Kingdom
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Glasgow, United Kingdom
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Nottingham, United Kingdom
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Sheffield, United Kingdom
Related Publications (1)
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.
PMID: 18779612DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Iressa Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 20, 2005
First Posted
November 22, 2005
Study Start
July 1, 2004
Study Completion
February 1, 2006
Last Updated
April 23, 2009
Record last verified: 2009-04