Phase II study of oxaliplatin (OXA) and docetaxel (DTX) in recurrent ovarian cancer

5086 Background: We conducted a phase II study to evaluate the efficacy and safety of OXA and DTX in recurrent platinum-sensitive ovarian cancer patients. Methods: Patients received DTX 75 mg/m2 (60-min i.v.) on day 1, followed by OXA 100 mg/ m2 (120-min i.v.) on day 1 every 21 days. Results: Between October 2002 and November 2005, 30 Caucasian patients (median age: 53.5 yrs; range, 31–73) were enrolled; 7 (23.3%) patients had FIGO stage I-II disease, 22 (73.3%) had FIGO stage III, and 1 (3.3%) had FIGO stage IV disease. Sites of relapse were as follows: abdominal 3 (10.0%), pelvis 5 (16.7%), lymph nodes 10 (33.3%), peritoneal 7 (23.3%), lung 1 (3.3%), and mixed 4 (13.3%). The median PFI was 28.5 months (range 13–91). The median CA125 was 182 U/ml (range 21–5,596 U/ml). Of the 30 patients evaluable, 13 (43.3%) had complete responses and 7 (23.3%) had partial responses, for an overall response rate of 66.6%. The median time to response was 9.5 wks (range 5–32) and the median duration of response was 43 wks (range 5–124). 8 (26.7%) patients had stable disease (median duration of stabilization: 26.5 wks, range 12–43). 2 (6.7%) patients progressed while on treatment. An overall clinical benefit was observed in 93.3% of patients. All patients were evaluable for toxicity. A total of 186 courses were given, with a median of 6 cycles per patient (range 2–11). Severe toxicities (Grade 3–4 NCI-CTC) included: neutropenia in 29.4% of cycles; severe anemia and thrombocytopenia were not observed. Grade 3–4 neurotoxicity and alopecia were detected in 2.8% and 22.8% of cycles respectively. Allergic reaction was observed only in one case. Doses were reduced by 20% in 14.0% of cycles. Conclusions: In recurrent platinum-sensitive ovarian cancer patients the OXA/DTX combination is highly active with acceptable toxicity, thus making it an attractive regimen. No significant financial relationships to disclose.