A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy

CompletadoFase 3ClinicalTrials.gov

ID: NCT00076388Tipo: INTERVENTIONALInicio: 1 de feb de 2004Fin estimado: 1 de oct de 2007

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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)

Intervenciones

drug

Gefitinib

drug

Docetaxel

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Córdoba, Argentina

Research site

El Palomar, Argentina

Research Site

Mar del Plata, Argentina

Research Site

Quilmes, Argentina

Research Site

Rosario, Argentina

Research Site

San Miguel de Tucumán, Argentina

Research Site

Santa Fe, Argentina

Patrocinadores

PrincipalAstraZeneca

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