Prolonged infusion of gemcitabine in patients with platinum resistant or refractory recurrent ovarian carcinoma: A phase II study Of GEICO (Spanish Group for investigation on ovarian cancer)

Abstract

5101 Background: Preclinical and clinical evidence suggests that a prolonged infusion may be more effective than the standard 30-minute infusion of gemcitabine. To investigate the activity and toxicity of gemcitabine infused over 2 hours in patients with platinum resistant or refractory recurrent ovarian carcinoma. Methods: A multi-center phase II study was conducted in patients with recurrent platinum-resistant or refractory ovarian carcinoma. Patients were to receive gemcitabine 1000 mg/m2 over 2 hours on days 1 and 8 every 21 days for at least 6 cycles unless disease progression or unacceptable toxicity occurs. Results: From August, 2003 to October, 2004, 39 patients have been included. Toxicity and efficacy data from first 20 patients are presented. Median age was 64 (range: 30–77). Median platinum-free interval was 3.65 months. 77 cycles have been administered (median of 3 cycles per patient, range: 1–10). Dose delay was required in 27% of cycles and dose reduction was indicated in 2 pts. Dose on day 8 was reduced in 26% of cycles and missed in 11.6% of cycles according to protocol dose modifications. Grade 3–4 haematological toxicities were (% of pts): anemia 20%, neutropenia 15%, and thrombocytopenia 5%. 2 pts had low-risk neutropenic fever. The most frequent non-haematological grade 2–3 toxicities were (% of pts): asthenia 25% (2 pts G2 and 3 pts G3) and nausea 15% (3 pts G2). There were 3 partial responses (15%; 95% CI: 0–30%) and no complete responses observed. Two patients had stable disease (10%) and 15 pts progressed on therapy (75%). Median time to progression was 2 months. Conclusions: These preliminary data suggest that the activity of a prolonged infusion of gemcitabine is comparable with the standard 30-min infusion. The recruitment will continue until the endpoint of 41 patients. Mature data of toxicity and efficacy will be presented. No significant financial relationships to disclose.