Entry Detail
| General information | |
| Database: | DB00970 |
| Objective: | The primary objective of this study was to determine whether carboplatin, paclitaxel, and sorafenib (CPS) improve overall survival (OS) compared with carboplatin and paclitaxel (CP) in chemotherapynaive patients with metastatic melanoma |
| Authors: | Flaherty KT, et al |
| Title: | Phase III trial of carboplatin and paclitaxel with or without sorafenib in metastatic melanoma. |
| Journal: | J Clin Oncol. |
| Year: | 2013 |
| PMID: | 23248256 |
| Trial Design | |
| Clinical Trial Id: | NCT00110019 |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | melanoma |
| Cancer Subtype: | advanced melanoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | carboplatin + paclitaxel with sorafenib |
| Study Type: | doubleblind, randomized, placebocontrolledphase III study |
| Key Patients Feature: | chemotherapynaive patients with metastatic melanoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | carboplatin and paclitaxel with sorafenib vresus carboplatin and paclitaxel |
| Treatment Info: | all patients received carboplatin at area under the [concentrationtime] curve 6 and paclitaxel 225 mg/m(2) intravenously once every 21 days with random assignment to sorafenib 400 mg orally twice per day on days 2 through 19 every 21 days or placebo. |
| Primary End Point: | OS |
| Secondary End Point: | progression free survival, objective tumor response, and toxicity |
| Patients Number: | 823 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 20% for CPS and 18% for CP (P = .427). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.9 months for CPS and 4.2 months for CP (P = .092, stratified logrank test). |
| Median OS A vs. C: | 11.3 months (95% CI, 9.8 to 12.2 months) for CP and 11.1 months (95% CI, 10.3 to 12.3 months) for CPS |
| Adverse Event(agent arm): | More patients on the CPS arm had grade 3 or higher toxicities (84% v 78%; P = .027), with increased rash, handfoot syndrome, and thrombocytopenia accounting for most of the difference. |
| Conclusions: | Sorafenib does not improve OS when given in combination with CP for chemotherapynaive patients with metastatic melanoma. This study establishes benchmark end points for the CP regimen in firstline therapy of metastatic melanoma. |