Status:
COMPLETED
Phase II Iressa Versus Vinorelbine (INVITE)
Lead Sponsor:
AstraZeneca
Conditions:
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
70+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00256711
Start Date
July 1 2004
End Date
February 1 2006
Last Update
April 23 2009
Active Locations (55)
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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