Entry Detail
| General information | |
| Database: | DB00091 |
| Objective: | to evaluate the efficacy, safety, and tolerability of pazopanib in combination with pemetrexed compared with the standard cisplatin/pemetrexed doublet in patients with previously untreated, advanced, nonsquamous non small cell lung cancer. |
| Authors: | Scagliotti GV, et al |
| Title: | An openlabel, multicenter, randomized, phase II study of pazopanib in combination with pemetrexed in firstline treatment of patients with advancedstage non small cell lung cancer. |
| Journal: | J Thorac Oncol. |
| Year: | 2013 |
| PMID: | 24389434 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | pazopanib |
| Target: | Plateletderived growth factor receptor Mast/stem cell growth factor receptor 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: | pazopanib+pemetrexed |
| Study Type: | An openlabel, multicenter, randomized, phase II study |
| Key Patients Feature: | Chemotherapynaive patients with histologically or cytologically proven predominantly nonsquamous cell stage IIIB theyt (with confirmed malignant pleural effusion) or stage IV non small cell lung cancer according to the 6th edition of Tumor, Node, Metastasis classification |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | pazopanib+pemetrexed VS cisplatin+pemetrexed |
| Treatment Info: | patients were randomized (2:1 ratio) to receive pemetrexed 500 mg/m(2) intravenously once every 3 weeks plus either oral pazopanib 800 mg daily or cisplatin 75 mg/m(2) intravenously once every 3 weeks up to six cycles. All patients received folic acid, vitamin B12, and steroid prophylaxis. |
| Primary End Point: | progression free survival (PFS). |
| Secondary End Point: | NA |
| Patients Number: | 106 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | pazopanib/pemetrexed and cisplatin/pemetrexed arms for PFS ( 25.0 versus 22.9 weeks, HR = 0.75; 95%CI, 0.43%1.28%; p = 0.26) |
| Median OS A vs. C: | pazopanib/pemetrexed and cisplatin/pemetrexed arms for OS(23% vs 34%; 95%CI, 30.6% to 7.2%; p = 0.21). |
| Adverse Event(agent arm): | three fatal adverse events in the pazopanib/pemetrexed arm, including ileus, tumor embolism, and bronchopneumonia/sepsis. |
| Conclusions: | The combination of pazopanibpemetrexed in firstline treatment of non small cell lung cancer showed some antitumor activity but had unacceptable levels of toxicity. |