Entry Detail
| General information | |
| Database: | DB00541 |
| Objective: | Sorafenib, an oral multikinase inhibitor of the VEGFR/PDGFR/Raf/MEK/ERK pathway, has shown potential activity in patients with recurrent ovarian cancer (OC). One strategy to prolong disease control and survival in patients with OC is maintenance therapy after achieving a complete response. A doubleblind, randomized, placebocontrolled, phase II study to assess the efficacy and safety of maintenance therapy with sorafenib in the treatment of OC is presented. |
| Authors: | Herzog TJ, et al |
| Title: | A randomizedphase II trial of maintenance therapy with Sorafenib in frontline ovarian carcinoma. |
| Journal: | Gynecol Oncol. |
| Year: | 2013 |
| PMID: | 23591401 |
| Trial Design | |
| Clinical Trial Id: | NCT00791778 |
| 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: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a randomized, doubleblind, placebocontrolled, multicenter, phase IIB study |
| Key Patients Feature: | Women with advanced stage (International Federation of Gynecology and Obstetrics [FIGO] stage III or IV) ovarian epithelial canceror primary peritoneal cancer (histologically confirmed at presentation)who achieved clinical complete response (CR) after tumor debulkingand one regimen of standardized platinum/taxanecontaining therapywere eligible for this study. All patients were at least 18 years oldwith a life expectancy of more than and equal to 12 weeks and an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Eligible patients were alsorequired to have normal CA125 levels within 14 days of study entryas well as adequate bone marrow, hepatic, and renal function. An eligibility scan consisting of either a CT or MRI of the chest, abdomen, andpelvis must have been completed within 60 days of the date of thelast dose of prior chemotherapy and scans to document CR (disappearance of all clinical and radiologic evidence of tumor) must have beendone within 42 days prior to randomization. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts were randomized to sorafenib 400mg BID or matching placebo. |
| Primary End Point: | progression free survival (PFS) |
| Secondary End Point: | NA |
| Patients Number: | 246 |
| Trial Results | |
| DLT_MTD: | Sorafenib 400mg BID cannot be recommended as maintenance therapy for patients with OC in complete remission |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | median 12.7 vs 15.7 months; hazard ratio 1.09; 95% CI 0.72-1.63 |
| Median OS A vs. C: | OS is difficult to interpret due to the low number of events (median NR; HR 1.48; 95% CI 0.69-3.23) |
| Adverse Event(agent arm): | The most common more than and equal to grade 3 adverse events (AEs) were hand-foot skin reaction (39.0% vs 0.8%) and rash (14.6% vs 0%). |
| Conclusions: | Sorafenib 400mg BID cannot be recommended as maintenance therapy for patients with OC in complete remission. Assessment of efficacy was limited by the high rate of dose reductions and early discontinuations. |