| General information |
| Database: | DB00797 |
| Objective: | Inhibition of angiogenesis is a novel strategy for the treatment of cancer. they evaluated the safety and efficacy of cediranib, a potent small molecule inhibitor of the vascular endothelial growth factor receptor, in patients with refractory or recurrent small cell lung cancer (SCLC). |
| Authors: | Ramalingam SS, et al |
| Title: | Phase II study of Cediranib (AZD 2171), an inhibitor of the vascular endothelial growth factor receptor, for secondline therapy of small cell lung cancer (National Cancer Institute #7097) |
| Journal: | J Thorac Oncol. |
| Year: | 2010 |
| PMID: | 20559150 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cediranib
|
| Target: | Vascular endothelial growth factor receptor 2
|
| Cancer Type: | smallcell lung cancer |
| Cancer Subtype: | small cell lung cancer. |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase II study |
| Key Patients Feature: | Patients with SCLC with progression after prior platinumbased chemotherapy only; performance status (PS) of 0 to 2; and adequate bone marrow, renal, and hepatic function were included. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | The dose of cediranib was 45 mg PO once a day for the first 12 patients and was reduced to 30 mg PO once a day for the subsequent patients because of intolerance of the higher dose. Treatment was given on a daily continuous schedule. |
| Primary End Point: | determination of the response rate. |
| Secondary End Point: | NA |
| Patients Number: | 25 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2 months |
| Median OS A vs. C: | 6 months; At the 30 mg dose level, median OS was 4 months |
| Adverse Event(agent arm): | NA |
| Conclusions: | Cediranib failed to demonstrate objective responses in recurrent or refractory SCLC at the dose and schedule evaluated. The 45 mg dose was intolerable in a majority of SCLC patients. |