| General information |
| Database: | DB00800 |
| Objective: | This randomised doubleblind placebocontrolled study evaluated the addition of cediranib, an inhibitor of vascular endothelial growth factor receptors 13, to standard carboplatin/paclitaxel chemotherapy in advanced non small cell lung cancer. |
| Authors: | Laurie SA, et al |
| Title: | Randomised, doubleblind trial of carboplatin and paclitaxel with daily oral cediranib or placebo in patients with advanced non small cell lung cancer: NCIC Clinical Trials Group study BR29. |
| Journal: | Eur J Cancer. |
| Year: | 2014 |
| PMID: | 24360368 |
| Trial Design |
| Clinical Trial Id: | NCT00795340 |
| Agent: | cediranib
|
| Target: | Vascular endothelial growth factor receptor 2
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | carboplatin + paclitaxel with cediranib |
| Study Type: | randomised doubleblind placebocontrolled study |
| Key Patients Feature: | Eligible adult patients had advanced, incurable, pathologicallyproven non small cell lung cancer (any histology), Eastern Cooperative Oncology Group Performance Status of 0-1, adequate organ function, and weight loss of <10% in the preceding 3 months (those with weight loss unknown or 5-10% required albumin of 30 g/l). |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | carboplatin and paclitaxel with daily oral cediranib verus carboplatin and paclitaxel with daily oral placebo |
| Treatment Info: | Eligible patients received paclitaxel (200mg/m(2)) and carboplatin (area under the concentration time curve 6) intravenously every 3 weeks. Daily oral cediranib/placebo 20mg was commenced day 1 of cycle 1 and continued as monotherapy after completion of 46 cycles of chemotherapy. |
| Primary End Point: | overall survival (OS). |
| Secondary End Point: | NA |
| Patients Number: | 306 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 52% and 34% (odds ratio 2.14, 95% CI 1.34-3.40, p = 0.001) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5.5 months in each arm (HR 0.91, 95% CI 0.71-1.18, p = 0.49). |
| Median OS A vs. C: | 12.2 and 12.1 months for cediranib and placebo, respectively (HR 0.94, 95% CI 0.69-1.30, p = 0.72) |
| Adverse Event(agent arm): | median duration of response of 4.3 (cediranib) and 4.2 months (placebo). |
| Conclusions: | The addition of cediranib 20mg daily to carboplatinpaclitaxel chemotherapy increased RR and toxicity, but not survival. |