Gemcitabine (GEM) + oxaliplatin (OX) in patients (pts) with stage III/IV ovarian cancer following 3 cycles of carboplatin (CB) + paclitaxel (PAC): Preliminary report of a phase II study

5111 Background: GEM is active in recurrent epithelial ovarian cancer. OX activity in ovarian cancer is similar to cisplatin in first-line therapy and PAC in nonrefractory relapses. This multicenter, prospective phase II study combines GEM/OX as first-line sequential therapy for advanced ovarian cancer in pts after 3 cycles of CB/PAC. Primary endpoint is time to disease progression; secondary endpoints are CA 125 response rate, objective response, response duration, overall survival, correlation between expression of MMR and p53 and efficacy, and toxicity. Methods: Pts with confirmed histologic diagnosis of stage III/IV epithelial ovarian carcinoma, initial surgery including anexohysterectomy + omentectomy, 3 cycles of CB ≥AUC 5 and PAC ≥175 mg/m2, no other prior chemotherapy, and adequate organ and marrow function were enrolled. Three to 4 weeks after CB/PAC, pts received GEM 1000 mg/m2 on days (d) 1,15 (100-minute infusion) and OX 85 mg/m2 on d2,16 (120-minute infusion), q28d. Results: To date, 18 pts (...