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Completed

NCT Number: NCT00256711

Phase II Iressa Versus Vinorelbine (INVITE)

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.

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Key information

Conditions

Non-Small-Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, St Leonards, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gefitinib

Drug

Vinorelbine

Drug

Primary outcomes

  1. To compare ZD1839 and vinorelbine in terms of progression free survival

Secondary outcomes

  1. To compare ZD1839 and vinorelbine in terms of pulmonary symptom improvement weekly for 18 weeks.

  2. To compare ZD1839 and vinorelbine in terms of quality of life 3 weekly for 18 weeks then 6 weekly.

  3. To compare ZD1839 and vinorelbine in terms of adverse event profile continuous monitoring.

  4. To compare ZD1839 and vinorelbine in terms of overall objective tumour response rate (complete response and partial response) 6 weekly to progression.

  5. To compare ZD1839 and vinorelbine in terms of overall survival (time to death) continuous monitoring

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2006
First posted
Nov 22, 2005
Registry last updated
Apr 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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