Non-Small-Cell Lung Carcinoma
Conditions
Keywords
Non-Small-Cell Lung Cancer
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.
Interventions
DRUGGefitinib
DRUGDocetaxel
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare overall survival between ZD1839 and docetaxel | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Argentina, Belgium, Brazil, Canada, China, Croatia, Denmark, Estonia, France, Germany, Hong Kong, Indonesia, Italy, Latvia, Malaysia, Mexico, Philippines, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey (Türkiye), United States
Outcome results
None listed