10002 Background: Angiosarcomas (AS) are unfrequent tumors with aggressive metastatic spreading. Although no prospective clinical trial has been so far specifically dedicated to these advanced tumors, their treatments are usually anthracyclin-based. However, a single institution-based retrospective study has suggested that paclitaxel (P) may have some efficacy in metastatic AS [Fata F et al. Cancer 1999, 86, 2034–7]. The aim of the following phase II study is to prospectively evaluate the efficacy and tolerance of weekly P in metastatic AS. Methods: Eligible patients were as follows: =18 years-old, measurable histologically-proven metastatic AS, and either naïve or pretreated patients (pts). Pts were planned to receive P 80 mg/m2 on day 1, 8 and 15, every 28 days until progression or severe toxicity. The primary endpoint was the objective response rate after 2 cycles, according to RECIST. A two stages Simon‘s optimal design was used with p0=10%, p1=30%, a=0.05 and 80% power. Results: From 04/2005 to 10/2006, 30 pts were included in 12 centers. There were 19 female and 11 male, and the mean age was 63 (range 23–85). Main primaries were breast, skin or scalp, liver and kidney in 8, 8, 3 and 2 cases, respectively. 33% (10/30) of these AS occurred in irradiated fields (9 for breast adenocarcinoma). Seventy three per cent of the pts (22/30) had previous surgery and 47% (14/30) previous chemotherapy, including anthracyclin in all cases. The number of pts who received 3, 4, 5 and 6 cycles of P were 15, 11, 6 and 4, respectively. Grade (G) 4 toxicity was reported in 1 case (neutropenia). G2 and 3 toxicities were notified for 27/30 pts including myalgias in 15 cases (55%), leuco-neutropenia in 14 cases (51%), infections in 6 cases (22%), and anemia in 4 cases (15%). As of 12/2006, 23 pts were evaluable for response, with 4 (14%) PR, 14 (56%) SD and 7 (30%) PD. The overall tumor- control rate (PR+SD) was 16/23 (70% (95% CI:50–88%). Conclusions: Weekly paclitaxel induces a significant tumor control with manageable toxicity for metastatic AS. No significant financial relationships to disclose.