Phase II Iressa Versus Vinorelbine (INVITE)

NCT ID: NCT00256711

Last Updated: 2009-04-23

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

PHASE2

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Small-Cell Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gefitinib

Intervention Type DRUG

Vinorelbine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Iressa Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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, City state of 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

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Countries

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Australia Brazil Czechia France Germany Italy South Africa South Korea Taiwan United Kingdom

References

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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.

Reference Type DERIVED
PMID: 18779612 (View on PubMed)

Other Identifiers

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INVITE

Identifier Type: -

Identifier Source: secondary_id

D791AC00001

Identifier Type: -

Identifier Source: org_study_id

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