A comparative randomized, placebo-controlled, double-blind phase II study with and without enzastaurin in combination with paclitaxel and carboplatin as first-line treatment for advanced ovarian cancer.

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5010 Background: Enzastaurin (E) is a potent, selective serine-threonine kinase inhibitor which suppresses tumor cell proliferation by targeting PKCβ and PI3/AKT pathways, inducing apoptosis and inhibiting angiogenesis. E may be effective as an add-on to other chemotherapy regimens. Methods: The primary aim of this multicenter, phase II, randomized, placebo-controlled double blind study was to compare progression-free survival (PFS) of first-line therapy of carboplatin (C) plus paclitaxel (P) with/without E (CPE/CP) followed by maintenance therapy, in patients with primary advanced ovarian cancer. Patients (FIGO Stage IIB-IV) were randomized (stratification factors: optimal (=0) vs. suboptimal (>0cm) tumor debulking, FIGO stage IIB-IIIB vs. IIIC-IV, and center) to receive CPE or CP (C [AUC 5 mg/mL/min], P [175 mg/m2, 3 hours infusion], E [1125 mg one day prior to CP treatment followed by 500 mg daily oral doses]) on Day 1 every 3 weeks for 6 cycles of 21 days each, followed by 3 yrs maintenance therapy wi...