Iressa Versus Docetaxel (Taxotere)

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Non-Small-Cell Lung Carcinoma

Treatments

Drug: Docetaxel

Drug: Gefitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00076388

D791GC00001

EudraCT No: 2004-002943-28

1839IL/0721

Details and patient eligibility

About

The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Measurable (uni dimensional) disease by RECIST criteria in a lesion not previously irradiated or non measurable disease
Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
Advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy
WHO performance status (PS) 0-2
Absolute Neutrophil Count (ANC) >1.5 x 109/liter (L) and platelets >100 x 109/L
Life expectancy of at least 8 weeks

Exclusion criteria

Prior ZD1839 therapy
Prior docetaxel treatment for NSCLC
Less than 14 days since completion of prior radiotherapy
Less than 21 days since prior chemotherapy, immunotherapy or biological systemic anticancer therapy
Evidence of clinically active Interstitial Lung Disease
Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
Newly diagnosed CNS metastases that have not yet been treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically SD (no steroid therapy or steroid dose being tapered) for at least 28 days
Patients with pre existing peripheral neuropathy >= grade 2 (NCI CTC criteria)