Phase II pilot study of biweekly cisplatin and gemcitabine in multi-refractory ovarian cancer

16065 Background: Preclinical data suggest the combination of cisplatin and gemcitabine may have synergy in inhibiting ovarian cancer growth in vitro. Clinical trials in breast cancer support the use of biweekly gemcitabine. A pilot trial of biweekly cisplatin and gemcitabine in multi-refractory ovarian cancer was undertaken. Methods: This was a single-stage phase II pilot trial. Eligible patients had platinum-resistant, multidrug-refractory epithelial ovarian cancer with CA125 levels exceeding 90 units/ml and acceptable renal, hepatic, and bone marrow function. Cisplatin 30 mg/m2 IV and gemcitabine 800–1000 mg/m2 IV were given biweekly (d1, 15) and CA125 levles monitored. Toxicity was monitored before each course and graded by NCI-CTC. Responses were measured using Rustin's criteria (JCO 15:172,1997). Treatment was continued until disease progression or prohibitive toxicity supervened. Results: Eleven patients aged 30–71 years (median 58 years) with advanced ovarian cancer received cisplatin and gemcitab...