Phase II multicenter trial of the histone deactylase inhibitor (HDACi) belinostat, carboplatin and paclitaxel (BelCaP) in patients (pts) with relapsed epithelial ovarian cancer (EOC)

5519 Background: Preclinical data show that belinostat (Bel) is synergistic with carboplatin and paclitaxel in platinum-sensitive and resistant models of ovarian cancer. This Phase II study was conducted to evaluate the efficacy of BelCaP in pts with relapsed EOC. Methods: Eligible pts had recurrent EOC and ECOG PS 0–2. BelCaP (Bel 1,000 mg/m2 x5 days; carboplatin AUC 5 x1 day 3; paclitaxel 175 mg/m2 x1 day 3) was given in 3 week cycles. The primary endpoint was overall response rate (ORR), using a Simon 2-stage design. Results: Accrual was completed in Dec 2007 (n=35); median age was 60 years (range 39 -80). Pts had received a median of 3 prior regimens (range 1–4). All pts had prior platinum therapy; median platinum-free interval was 12.5 months (m) (range 0.6–60 m), and 11 (31%) had relapsed within 6 m of first platinum therapy. Pts received a median of 4 cycles (range 1–13) of BelCaP; 17 continue on therapy. OR was 31%, including 1 complete response and 10 partial responses (PR). In addition, 16 pts (...