Status: Closed
Activation Date: 2005SEP07
Closing Date: 2008FEB25
Phase: II
Description: A Phase II/III Double Blind Randomized Trial of AZD2171 versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer
Eligibility: Histologically or cytologically confirmed diagnosis of stage IIIB or stage IV NSCLC. For phase II, the first 150 patients must have unidimensionally measurable disease by RECIST criteria. Prior adjuvant chemotherapy permitted (completed >=12 months), prior EGFR inhibitor therapy permitted (completed >=14 days). No prior anti-angiogenesis therapy permitted, no prior chemotherapy for metastatic or recurrent disease permitted. Patients must be > 21 days since radiation therapy and > 14 days since previous surgery.
Objective: Phase II: To compare the progression-free survival between arms. To compare the objective tumour response rate in each arm. To evaluate the nature, severity, and frequency of toxicities, including hemorrhage and hemoptysis between the two arms. To examine pharmacogenomic and pharmacodynamic aspects of treamtent. Phase III: To compare overall survival between the two arms. To compare progression-free survival between arms. To compare objective response rates (RR) in each arm. To estimate time to response and response duration. To evaluate the nature, severity, and frequency of toxicities, including hemorrhage and hemoptysis between the two arms. To correlate the expression of tissue markers (at diagnosis) with outcomes and response. To compare Quality of Life between the two arms.
Participation: Limited to invited centres only.
Lay Description: The purpose of this study is to find out whether it is better to receive the combined regimen AZD2171 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 AZD2171 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 AZD2171 to standard chemotherapy can offer better results than standard chemotherapy.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| LUNG | BR24 | 296 | 53 | 118 | 145 |
(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 | BR24 | 296 | 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 | BR24 | 296 | 234 | 0 | 234 | 235 | 249 | 254 | 0 | 0 |