Phase II Iressa Versus Vinorelbine (INVITE)

Non-Small-Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00256711
• Other study ID #: D791AC00001
• Secondary ID: INVITE
• Status: Completed
• Phase: Phase 2
• First received: November 20, 2005
• Last updated: April 22, 2009
• Start date: July 2004
• Est. completion date: February 2006

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

Drug:
• Gefitinib

• Vinorelbine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Brazil,  Czech Republic,  France,  Germany,  Italy,  Korea, Republic of,  South Africa,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare ZD1839 and vinorelbine in terms of progression free survival
Secondary	To compare ZD1839 and vinorelbine in terms of pulmonary symptom improvement weekly for 18 weeks.
Secondary	To compare ZD1839 and vinorelbine in terms of quality of life 3 weekly for 18 weeks then 6 weekly.
Secondary	To compare ZD1839 and vinorelbine in terms of adverse event profile continuous monitoring.
Secondary	To compare ZD1839 and vinorelbine in terms of overall objective tumour response rate (complete response and partial response) 6 weekly to progression.
Secondary	To compare ZD1839 and vinorelbine in terms of overall survival (time to death) continuous monitoring