Iressa Versus Docetaxel (Taxotere)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-Small-Cell Lung Carcinoma

Intervention / Treatment
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* Drug: Gefitinib
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gefitinib|nan|
|Drug: Docetaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare overall survival between ZD1839 and docetaxel |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Small-Cell Lung Cancer