Phase II Iressa Versus Vinorelbine (INVITE)

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00256711

Collaborator

(none)

192

Enrollment

Locations

19.1

Duration (Months)

3.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Small-Cell Lung Carcinoma	Drug: Gefitinib Drug: Vinorelbine	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2004

Actual Study Completion Date :

Feb 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	St. Leonards	New South Wales	Australia
2	Research Site	Westmead	New South Wales	Australia
3	Research Site	South Brisbane	Queensland	Australia
4	Research Site	Nedlands	Western Australia	Australia
5	Research Site	Victoria		Australia
6	Research Site	Fortaleza	CE	Brazil
7	Research Site	Goiania	GO	Brazil
8	Research Site	Rio de Janeiro	RJ	Brazil
9	Research Site	Sao Paulo	SP	Brazil
10	Research Site	Praha 8	CZ	Czech Republic
11	Research Site	Usti nad Labem	CZ	Czech Republic
12	Research Site	Hradec Kralove		Czech Republic
13	Research Site	Kutná Hora		Czech Republic
14	Research Site	Olomouc		Czech Republic
15	Research Site	Ostrava - Poruba		Czech Republic
16	Research Site	Ostrava		Czech Republic
17	Research Site	Plzen		Czech Republic
18	Research Site	Marseille Cedex 09		France
19	Research Site	Montpellier Cedex 5		France
20	Research Site	Montpellier Cedex		France
21	Research Site	Pierre Benite Cedex		France
22	Research Site	Vesoul Cedex		France
23	Research Site	Heidelberg	Baden-Württemberg	Germany
24	Research Site	Ulm	Baden-Württemberg	Germany
25	Research Site	München	Bayern	Germany
26	Research Site	Magdeburg	Sachsen-Anhalt	Germany
27	Research Site	Bad Segeberg	Schleswig-Holstein	Germany
28	Research Site	Berlin		Germany
29	Research Site	Großhansdorf		Germany
30	Research Site	Halle		Germany
31	Research Site	Hamburg		Germany
32	Research Site	Mainz		Germany
33	Research Site	La Torretta	Ancona	Italy
34	Research Site	Bergamo	BG	Italy
35	Research Site	Bologna	BO	Italy
36	Research Site	Catania	CT	Italy
37	Research Site	Melegnano	MI	Italy
38	Research Site	Milano	MI	Italy
39	Research Site	Rozzano	MI	Italy
40	Research Site	Modena	MO	Italy
41	Research Site	Parma	PR	Italy
42	Research Site	Orbassano	TO	Italy
43	Research Site	Torino	TO	Italy
44	Research Site	Napoli		Italy
45	Research Site	Seoul		Korea, Republic of
46	Research Site	Cape Town		South Africa
47	Research Site	Durban		South Africa
48	Research Site	Taichung		Taiwan
49	Research Site	Taipei		Taiwan
50	Research Site	Cambridge	Cambrideshire	United Kingdom
51	Research Site	Birmingham	West Midlands	United Kingdom
52	Research Site	Aberdeen		United Kingdom
53	Research Site	Dundee		United Kingdom
54	Research Site	Glasgow		United Kingdom
55	Research Site	Nottingham		United Kingdom
56	Research Site	Sheffield		United Kingdom