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Phase II Iressa Versus Vinorelbine (INVITE)

Primary Purpose

Non-Small-Cell Lung Carcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Gefitinib
Vinorelbine
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Carcinoma focused on measuring Locally advanced or metastatic NSCLC., Stage IIIb or Stage IV lung cancer

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

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Outcomes

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

Full Information

First Posted
November 20, 2005
Last Updated
April 22, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00256711
Brief Title
Phase II Iressa Versus Vinorelbine (INVITE)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Carcinoma
Keywords
Locally advanced or metastatic NSCLC., Stage IIIb or Stage IV lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gefitinib
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Primary Outcome Measure Information:
Title
To compare ZD1839 and vinorelbine in terms of progression free survival
Secondary Outcome Measure Information:
Title
To compare ZD1839 and vinorelbine in terms of pulmonary symptom improvement weekly for 18 weeks.
Title
To compare ZD1839 and vinorelbine in terms of quality of life 3 weekly for 18 weeks then 6 weekly.
Title
To compare ZD1839 and vinorelbine in terms of adverse event profile continuous monitoring.
Title
To compare ZD1839 and vinorelbine in terms of overall objective tumour response rate (complete response and partial response) 6 weekly to progression.
Title
To compare ZD1839 and vinorelbine in terms of overall survival (time to death) continuous monitoring

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Iressa Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
St. Leonards
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
South Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
Research Site
City
Victoria
Country
Australia
Facility Name
Research Site
City
Fortaleza
State/Province
CE
Country
Brazil
Facility Name
Research Site
City
Goiania
State/Province
GO
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
State/Province
RJ
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
State/Province
SP
Country
Brazil
Facility Name
Research Site
City
Praha 8
State/Province
CZ
Country
Czech Republic
Facility Name
Research Site
City
Usti nad Labem
State/Province
CZ
Country
Czech Republic
Facility Name
Research Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
Research Site
City
Kutná Hora
Country
Czech Republic
Facility Name
Research Site
City
Olomouc
Country
Czech Republic
Facility Name
Research Site
City
Ostrava - Poruba
Country
Czech Republic
Facility Name
Research Site
City
Ostrava
Country
Czech Republic
Facility Name
Research Site
City
Plzen
Country
Czech Republic
Facility Name
Research Site
City
Marseille Cedex 09
Country
France
Facility Name
Research Site
City
Montpellier Cedex 5
Country
France
Facility Name
Research Site
City
Montpellier Cedex
Country
France
Facility Name
Research Site
City
Pierre Benite Cedex
Country
France
Facility Name
Research Site
City
Vesoul Cedex
Country
France
Facility Name
Research Site
City
Heidelberg
State/Province
Baden-Württemberg
Country
Germany
Facility Name
Research Site
City
Ulm
State/Province
Baden-Württemberg
Country
Germany
Facility Name
Research Site
City
München
State/Province
Bayern
Country
Germany
Facility Name
Research Site
City
Magdeburg
State/Province
Sachsen-Anhalt
Country
Germany
Facility Name
Research Site
City
Bad Segeberg
State/Province
Schleswig-Holstein
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Großhansdorf
Country
Germany
Facility Name
Research Site
City
Halle
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Mainz
Country
Germany
Facility Name
Research Site
City
La Torretta
State/Province
Ancona
Country
Italy
Facility Name
Research Site
City
Bergamo
State/Province
BG
Country
Italy
Facility Name
Research Site
City
Bologna
State/Province
BO
Country
Italy
Facility Name
Research Site
City
Catania
State/Province
CT
Country
Italy
Facility Name
Research Site
City
Melegnano
State/Province
MI
Country
Italy
Facility Name
Research Site
City
Milano
State/Province
MI
Country
Italy
Facility Name
Research Site
City
Rozzano
State/Province
MI
Country
Italy
Facility Name
Research Site
City
Modena
State/Province
MO
Country
Italy
Facility Name
Research Site
City
Parma
State/Province
PR
Country
Italy
Facility Name
Research Site
City
Orbassano
State/Province
TO
Country
Italy
Facility Name
Research Site
City
Torino
State/Province
TO
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Durban
Country
South Africa
Facility Name
Research Site
City
Taichung
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Cambridge
State/Province
Cambrideshire
Country
United Kingdom
Facility Name
Research Site
City
Birmingham
State/Province
West Midlands
Country
United Kingdom
Facility Name
Research Site
City
Aberdeen
Country
United Kingdom
Facility Name
Research Site
City
Dundee
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Nottingham
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18779612
Citation
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.
Results Reference
derived

Learn more about this trial

Phase II Iressa Versus Vinorelbine (INVITE)

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