Phase II study of gemcitabine in ovarian cancer

This phase II study evaluated the response rate and toxicity of single-agen t gemcitabine in 40 women with epithelial ovarian cancer, previously treate d with platinum-based chemotherapy. Patients had stage III or IV disease an d progressive disease 1-12 months after the last treatment. Gemcitabine 125 0 mg/m(2) was administered on days 1, 8 and 15 of each 28-day cycle as a 30 -minute infusion. The overall response rate to gemcitabine was 22% (95% confidence intervals: 10-39%). Responses to gemcitabine were observed in patients with platinum- refractory disease, which suggests no cross resistance to platinum. Gemcita bine was well tolerated and no grade 4 toxicity was seen. This study confirms that gemcitabine is active and well tolerated in pre-tr eated women with ovarian cancer.