Phase II Iressa Versus Vinorelbine (INVITE)

April 22, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

192

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Victoria, Australia
        • Research Site
    • New South Wales
      • St. Leonards, New South Wales, Australia
        • Research Site
      • Westmead, New South Wales, Australia
        • Research Site
    • Queensland
      • South Brisbane, Queensland, Australia
        • Research Site
    • Western Australia
      • Nedlands, Western Australia, Australia
        • Research Site
  • Brazil
    • CE
      • Fortaleza, CE, Brazil
        • Research Site
    • GO
      • Goiania, GO, Brazil
        • Research Site
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Research Site
    • SP
      • Sao Paulo, SP, Brazil
        • Research Site
  • Czech Republic
      • Hradec Kralove, Czech Republic
        • Research Site
      • Kutná Hora, Czech Republic
        • Research Site
      • Olomouc, Czech Republic
        • Research Site
      • Ostrava, Czech Republic
        • Research Site
      • Ostrava - Poruba, Czech Republic
        • Research Site
      • Plzen, Czech Republic
        • Research Site
    • CZ
      • Praha 8, CZ, Czech Republic
        • Research Site
      • Usti nad Labem, CZ, Czech Republic
        • Research Site
  • France
      • Marseille Cedex 09, France
        • Research Site
      • Montpellier Cedex, France
        • Research Site
      • Montpellier Cedex 5, France
        • Research Site
      • Pierre Benite Cedex, France
        • Research Site
      • Vesoul Cedex, France
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Großhansdorf, Germany
        • Research Site
      • Halle, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany
        • Research Site
      • Ulm, Baden-Württemberg, Germany
        • Research Site
    • Bayern
      • München, Bayern, Germany
        • Research Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany
        • Research Site
    • Schleswig-Holstein
      • Bad Segeberg, Schleswig-Holstein, Germany
        • Research Site
  • Italy
      • Napoli, Italy
        • Research Site
    • Ancona
      • La Torretta, Ancona, Italy
        • Research Site
    • BG
      • Bergamo, BG, Italy
        • Research Site
    • BO
      • Bologna, BO, Italy
        • Research Site
    • CT
      • Catania, CT, Italy
        • Research Site
    • MI
      • Melegnano, MI, Italy
        • Research Site
      • Milano, MI, Italy
        • Research Site
      • Rozzano, MI, Italy
        • Research Site
    • MO
      • Modena, MO, Italy
        • Research Site
    • PR
      • Parma, PR, Italy
        • Research Site
    • TO
      • Orbassano, TO, Italy
        • Research Site
      • Torino, TO, Italy
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Research Site
  • South Africa
      • Cape Town, South Africa
        • Research Site
      • Durban, South Africa
        • Research Site
  • Taiwan
      • Taichung, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
  • United Kingdom
      • Aberdeen, United Kingdom
        • Research Site
      • Dundee, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Nottingham, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
    • Cambrideshire
      • Cambridge, Cambrideshire, United Kingdom
        • Research Site
    • West Midlands
      • Birmingham, West Midlands, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare ZD1839 and vinorelbine in terms of progression free survival

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Iressa Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

November 20, 2005

First Submitted That Met QC Criteria

November 20, 2005

First Posted (Estimate)

November 22, 2005

Study Record Updates

Last Update Posted (Estimate)

April 23, 2009

Last Update Submitted That Met QC Criteria

April 22, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D791AC00001
  • INVITE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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