Status: Closed
Activation Date: 2002APR10
Closing Date: 2005APR15
Phase: III
Description: A Phase III Trial of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed by Maintenance Therapy with ZD1839 or Placebo in Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer
Eligibility: Either histologic or cytologic proof of a newly diagnosed single, primary bronchogenic non-small cell lung cancer is required (adenocarcinoma, non-lobar and non-diffuse bronchioloalveolar cell carcinoma, large cell carcinoma or squamous cell carcinoma). A biopsy with histology is preferred, but cytology is allowed. Histology or cytology from involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs (i.e. a second biopsy will not be required).
Objective: To assess whether cisplatin plus etoposide with concurrent radiotherapy followed by three cycles of consolidation docetaxel followed by maintenance therapy with ZD1839 compared to placebo improves overall survival and progression-free survival in patients with unresectable Stage III non-small cell lung cancer (NSCLC). To describe the toxicity profile of long-term administration of ZD1839.
Participation: Open to member centres
Lay Description: The purpose of this study is to compare the effects on this non-small cell lung cancer of ZD1839 or placebo given after treatment with cisplatin, etoposide and radiation followed by docetaxel. ZD1839 is an experimental treatment. This study is being done to find out whether ZD1839 can improve survival of patients with non-small cell lung cancer after they have received chemotherapy. To do this, half of the patients in this study will get ZD1839 and the other half will get placebo (a substance that does not do anything). The benefit of ZD1839 on survival of lung cancer patients is currently unknown.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| LUNG | BR15 | 56 | 10 | 2 | 12 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| LUNG | BR15 | 56 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| LUNG | BR15 | 56 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |