Status: Closed
Activation Date: 2008NOV06
Closing Date: 2011MAY06
Phase: III
Description: A Double Blind Randomized Trial of Cediranib versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
Objective: This is a randomized, double blind, placebo controlled study of cediranib (AZD2171) given in combination with standard paclitaxel/carboplatin chemotherapy in patients with stage IIIB or IV non-small cell lung cancer. An early futility interim analysis is planned. Primary objective: To compare the overall survival between the 2 arms
Participation: Limited to invited centres
Lay Description: The purpose of this study is to find out whether it is better to receive the combined regimen cediranib and carboplatin/paclitaxel or to receive the standard chemotherapy treatment carboplatin/paclitaxel. To do this, half of the patients in this study will get the new drug cediranib in combination with carboplatin and paclitaxel and the other half will receive a placebo (a substance that does not do anything) with carboplatin and paclitaxel. This research is being done because it is not clear if the addition of the new drug cediranib to standard chemotherapy can offer better results than standard chemotherapy.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| LUNG | BR29 | 306 | 101 | 79 | 159 |
(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 | BR29 | 306 | 1 | 9 |
| 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 | BR29 | 306 | 55 | 0 | 15 | 15 | 58 | 57 | 0 | 0 |