Gemcitabine and oxaliplatin followed by paclitaxel and carboplatin as first line therapy for patients with advanced epithelial ovarian cancer. A phase II trial of sequential doublets. (GO-FIRST)

Abstract

5034 Background: Gemcitabine and oxaliplatin are active in epithelial ovarian cancer with minimal overlapping toxicity, and in pre-clinical studies have shown synergy. The primary objective of this prospective phase II study is to evaluate the response rate (RR) and toxicity of gemcitabine and oxaliplatin (GO) administered sequentially with paclitaxel and carboplatin (PC). Secondary objectives were time to progression, quality of life outcomes and overall survival. Methods: Patients with histologically proven epithelial ovarain cancer, FIGO stage II-IV, measurable disease (RECIST), and PS 0–2 were eligible. Treatment consisted of gemcitabine 1250mg/m2 D1, D8 and oxaliplatin 135mg/m2 D8 q21days for 4 cycles followed by carboplatin AUC6 and paclitaxel 175mg/m2 D1 q21days for 4 cycles. Interval debulking was permitted after 4 cycles. Results: 20 patients are enrolled. Median age 62 yrs (range 39–78), FIGO III-IV (16/4). 12/20 pts were only able to have an initial biopsy and of these, 7 were subsequently debu...