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Phase II Iressa Versus Vinorelbine (INVITE)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00256711
First received: November 20, 2005
Last updated: April 22, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-Small-Cell Lung Carcinoma
 Drug: Gefitinib
Drug: Vinorelbine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To compare ZD1839 and vinorelbine in terms of progression free survival

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 192
Study Start Date: July 2004
Study Completion Date: February 2006
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256711

  Show 56 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Iressa Medical Science Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00256711     History of Changes
Other Study ID Numbers: D791AC00001, INVITE
Study First Received: November 20, 2005
Last Updated: April 22, 2009
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by AstraZeneca:
Locally advanced or metastatic NSCLC.
Stage IIIb or Stage IV lung cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Vinorelbine
Gefitinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013