Iressa Versus Docetaxel (Taxotere)

Completed · Phase 3

Conditions studied: Non-Small-Cell Lung Carcinoma

In brief

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.

Key facts

Study ID

NCT00076388

Run by

AstraZeneca

People needed

1440

Starts

2004-02-01

Expected to finish

2007-10-01

Last updated by the study team

2011-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Research Site — Fountain Valley, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Santa Rosa, California, United States
• Research Site — Stockton, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Norwich, Connecticut, United States
• Research Site — Newark, Delaware, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Macon, Georgia, United States
• Research Site — Tucker, Georgia, United States
• Research Site — Skokie, Illinois, United States
• Research Site — Knoxville, Kentucky, United States
• Research Site — Saint Louis Park, Minnesota, United States
• Research Site — Great Neck, New York, United States
• Research Site — Rochester, New York, United States
• Research Site — Syracuse, New York, United States
• Research Site — Chapel Hill, North Carolina, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Portland, Oregon, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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