Phase II Iressa Versus Vinorelbine (INVITE)

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Non-Small-Cell Lung Carcinoma

Treatments

Drug: Vinorelbine

Drug: Gefitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00256711

D791AC00001

INVITE

Details and patient eligibility

About

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.

Sex

All

Ages

70+ years old

Volunteers

No 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