| General information |
| Database: | DB00801 |
| Objective: | Thisphase II/III doubleblind study assessed efficacy and safety of cediranib with standard chemotherapy as initial therapy for advanced non small cell lung cancer (non small cell lung cancer). |
| Authors: | Goss GD, et al |
| Title: | Randomized, doubleblind trial of carboplatin and paclitaxel with either daily oral cediranib or placebo in advanced non small cell lung cancer: NCIC clinical trials group BR24 study. |
| Journal: | J Clin Oncol. |
| Year: | 2010 |
| PMID: | 19917841 |
| Trial Design |
| Clinical Trial Id: | NA |
| 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: | phase II/III doubleblind 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 either daily oral cediranib verus carboplatin and paclitaxel with either daily oral placebo |
| Treatment Info: | Paclitaxel (200 mg/m(2)) and carboplatin (area under the serum concentrationtime curve 6) were given every 3 weeks, with daily oral cediranib or placebo at 30 mg (first 45 patients received 45 mg). |
| Primary End Point: | progression free survival (PFS) |
| Secondary End Point: | NA |
| Patients Number: | 296 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 10.5 months v 10.1 months; HR, 0.78; 95% CI, 0.57 to 1.06; P = .11 |
| Adverse Event(agent arm): | Cediranib patients were more likely to experience all causality severe hypertension, GI toxicity (diarrhea, anorexia, mucositis), febrile neutropenia, fatigue, granulocytopenia, and thrombocytopenia as well as more allgrade, allcausality dyspnea and handfoot syndrome compared with patients on placebo |
| Conclusions: | The addition of cediranib to carboplatinpaclitaxel results in improved response and PFS, but does not appear tolerable at a 30mg dose. Consequently, the National Cancer Institute of Canada Clinical Trials Group and the Australasian Lung Cancer Trials Group initiated a randomized, doubleblind, placebocontrolled trial of cediranib 20 mg with carboplatin and paclitaxel in advanced non small cell lung cancer. |