Entry Detail
| General information | |
| Database: | DB00760 |
| Objective: | This study was conducted to evaluate the efficacy and safety of sunitinib in patients with relapsed or refractory small cell lung cancer (SCLC) |
| Authors: | Han JY, et al |
| Title: | a phase II study of sunitinib in patients with relapsed or refractory small cell lung cancer. |
| Journal: | Lung Cancer. |
| Year: | 2013 |
| PMID: | 23182663 |
| Trial Design | |
| Clinical Trial Id: | NCT00620347 |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | smallcell lung cancer |
| Cancer Subtype: | small cell lung cancer. |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II study |
| Key Patients Feature: | Eligibility included histologic or cytologic diagnosis of SCLC, ECOG PS of 02, cancer progression following one or two prior chemotherapy or chemoradiotherapy (CRT) and adequate organ functions. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Treatment regimen consisted of a 6week cycle of sunitinib given as 50mg p.o. daily for 4 weeks follotheyd by 2 weeks off. |
| Primary End Point: | objective response rate (ORR). |
| Secondary End Point: | NA |
| Patients Number: | 25 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 9% (95% CI, 128%) |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.4 months (95% CI, 1.11.7) |
| Median OS A vs. C: | 5.6 months (95% CI, 3.57.7) |
| Adverse Event(agent arm): | NA |
| Conclusions: | Although tumor response was noted in 2 patients, the median PFS was short and most patients were unable to tolerate the treatment. At the current dose schedule, sunitinib does not appear to warrant further evaluation. |