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| ID | Type | Description | Link |
|---|---|---|---|
| 1839IL/0073 |
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The primary objective of the trial is to determine the Maximum tolerated dose, if any, of the combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up to 45 mg/m2 paclitaxel.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib | Drug | |||
| Carboplatin | Drug | |||
| Paclitaxel | Drug | |||
| Radiation | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the Maximum tolerated dose, if any, of the combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up to 45 mg/m2 paclitaxel. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the activity potential of the combination of ZD1839, carboplatin, paclitaxel & radiation therapy | ||
| Estimating the objective response rate (complete response [CR] & partial response [PR]) as assessed by positron emission tomography with (18F)-labelled fluorodeoxyglucose (PET-FDG) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Australia Medical Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Woolloonabba | Queensland | Australia | |||
| Research Site |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| To estimate the objective response rate (CR and PR) as assessed by computerised tomography (CT) scan |
| To estimate the complete response rate (CR) as assessed by PET-FDG |
| To estimate progression free survival (PFS) as assessed by clinical examination, chest x-ray, CT scan ± PET-FDG |
| To estimate overall survival |
| To characterise the safety and tolerability of ZD1839 combined with concurrent carboplatin, paclitaxel and radiation |
| To determine the site of first failure (characterised as local-regional, distant or both) |
| East Melbourne |
| Victoria |
| Australia |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D055585 | Physical Phenomena |