A randomized, double-blind, placebo-controlled, multicenter phase II study to compare the efficacy and safety of sorafenib added to standard treatment with topotecan to standard treatment alone in patients with platinum-resistant recurrent ovarian cancer (TRIAS): Results of a NOGGO-AGO intergroup pilot-study.

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e15548 Background: Response rates in patients with platinum resistant ovarian cancer are generally low and prognosis is very poor. Therefore new treatment strategies including the combination of chemotherapy and targeted therapies may improve the therapeutic index. TRIAS is a phase II trial of Sorafenib, a novel multitargeted kinase inhibitore plus Topotecan, an approved topoisomerase inhibitor, vs Topotecan alone in patients with platinum-resistant recurrent ovarian cancer. Here we present results from a preplanned blinded safety analysis. Methods: This is the first randomized, double-blind, placebo-controlled phase II trial in patients with in patients with platinum-resistant recurrent ovarian cancer. Primary endpoint is progression free survival. In total 184 patients will be randomized to receive either Topotecan 1,25mg/m2/d1-5 q 21d and Sorafenib (400mg twice daily, d 6-15/q21d) or Topotecan 1,25mg/m2/d1-5 q 21d and placebo. All hematological and non-hematological toxicities were compared with the data of the published TOWER study (J Clin Oncol). Results: Overall 12 consecutive patients were analyzed. A total of 38 cycles with a median (range) were evaluatedd. 7 SAE in 5 patients were reported: pleura effusion, port infection, anemia (two events), cholecystis, vomiting, rash. 4 patients discontinued therapy. A total of 31 Grade 3/4 events were observed. (. table 1) 9 non-hematological events grade 3/4 were observed including ALT/AST elevation γ-GT elevation, rash and pain). Conclusions: The combination of Sorafenib and standard regimen Topotecan is feasible and safe with an expected hematological and non-hematological toxicity profile allowing the continuation of this phase II trial.

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