Phase II Iressa Versus Vinorelbine (INVITE) - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00256711

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 II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Vinorelbine Vinorelbine tartrate ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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

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

Publications indexed to this study:

Crinò 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.

Study ID Numbers:	D791AC00001, INVITE
Study First Received:	November 20, 2005
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00256711
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

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Vinorelbine
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Disease Progression
Gefitinib
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009