A phase II study of Gemcitabine in platinum pre-treated patients with advanced epithelial ovarian cancer

Background. Most patients with advanced ovarian cancer will relapse followi ng platinum-based combination chemotherapy and be considered for second-lin e treatment. Gemcitabine, a nucleoside analogue, is active against a range of solid tumors. This phase II study investigated the activity of single-ag ent gemcitabine in patients with recurrent ovarian cancer. Patients and methods. Thirty-eight patients with FIGO stage III (34%) or IV (64%) ovarian cancer who were previously treated with platinum-containing regimens were enrolled. Patients received 1200 mg/m(2) gemcitabine on days 1, 8 and 15 of a 28-day cycle. Results. Patients completed an average of 3.6 cycles. Two complete and thre e partial responses were seen in 36 evaluable patients, for an overall resp onse rate of 13.9% (95% CI: 4.7%-29.5%). The median survival time was 6.7 m onths. Toxicities were generally mild. The most common were grade 3-4 neutr openia and grade 3 leukopenia reported in 23.7% and 10.5% of patients, resp ectively. One patient had grade 4 pulmonary toxicity. Conclusion. Single-agent gemcitabine is active and well tolerated in patien ts with recurrent ovarian cancer.