Iressa Versus Docetaxel (Taxotere)

Phase 3

Completed

• Conditions: Non-Small-Cell Lung Carcinoma

• Registration Number: NCT00076388
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-01-21
• Study First Submitted QC: 2004-01-22
• Study First Posted: 2004-01-23
• Study Start: 2004-02
• Primary Completion: 2007-03
• Study Completion: 2007-10
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-12
• Last Update Posted: 2011-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1440

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare overall survival between ZD1839 and docetaxel

Secondary Outcome Measures

Name	Time	Method
To compare time to progression (TTP) between ZD1839 and docetaxel
To compare progression-free rates at 4 months and 6 months between ZD1839 and docetaxel
To compare the overall objective tumor response rate between ZD1839 and docetaxel
To compare patient-reported functionality (PRF) and quality of life (QoL) between ZD1839 and docetaxel
To compare safety and tolerability of ZD1839 and docetaxel

Trial Locations

Locations (2)

Research Site; 🇹🇷 Izmir, Turkey

Research site; 🇦🇷 El Palomar, Argentina