Entry Detail
| General information | |
| Database: | DB00546 |
| Objective: | Sorafenib is a novel oral anticancer agent targeting signal transduction and angiogenic pathways through inhibitory effects against MAP kinases and vascular endothelial growth factor receptor2. The objectives of this neoadjuvantphase IItrial in patients with advanced epithelial ovarian cancer were to assess the activity and tolerability of the combination therapy of carboplatin/paclitaxel with multitarget tyrosine kinase inhibitor sorafenib. |
| Authors: | P lcher M, et al |
| Title: | Sorafenib in combination with carboplatin and paclitaxel as neoadjuvant chemotherapy in patients with advanced ovarian cancer. |
| Journal: | Cancer Chemother Pharmacol |
| Year: | 2010 |
| PMID: | 20204367 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | ovarian cancer |
| Cancer Subtype: | advanced ovarian epithelial cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Sorafenib + carboplatin and paclitaxel |
| Study Type: | phase IItrial |
| Key Patients Feature: | This study included patients with histologically conWrmedFIGO stage IIIC and IV epithelial ovarian cancer and anascites volume of 500 ml or more |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Enrolled patients received 2 of 6 cycles carboplatin (area under the curve 5) and paclitaxel (175 mg/m(2)) preoperatively and concomitant sorafenib 400 mg twice daily. After four cycles of postoperative chemotherapy, a maintenancephase of single agent oral sorafenib through 1 year was planned. |
| Primary End Point: | progression free survival. |
| Secondary End Point: | NA |
| Patients Number: | 4 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | Threepatients had life threatening events (cardiac output failure, myocardial infarction, anastomotic leak); two patients hadprimary progressive disease. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Frequently reported drugrelated adverse events at any grade included fatigue (40%), anorexia (35%), diarrhea (34%), rash/desquamation (27%), and hand-foot skin reaction (25%). |
| Conclusions: | The addition of sorafenib to carboplatinpaclitaxel chemotherapy was not feasible within this neoadjuvant regimen in primary advanced ovarian cancer. Although the occurrence of serious adverse events might have emerged at random, a detrimental effect of preoperative study medication could not be denied. Further evaluations of sorafenib in ovarian cancer are warranted. |