A phase II trial of dacarbazine (DTIC) and bevacizumab in patients with metastatic melanoma

8579 Background: Dacarbazine (DTIC) has been approved for treating metastatic melanoma in the 1970s, and as a single agent gives a response rate of about 20%. There have been efforts to ameliorate this poor result by using DTIC in different combinations without a significant improvement. In addition, new studies with melanoma cells in vitro show that DTIC causes transcriptional up-regulation of vascular endothelial growth factor (VEGF), suggesting a potential clinical benefit from the concomitant treatment of DTIC and anti-VEGF therapy. The purpose of this study is to determine whether a combination therapy of bevacizumab and DTIC is safe and can increase response rate and progression-free survival in patients (pts) with metastatic melanoma. Methods: From June 2006 to December 2006, 8 chemo-naive pts (1 female and 7 males) with metastatic melanoma were enrolled in the study. The median age was 53 (43–74) and PS was 0–1. Patients received DTIC 800 mg/m 2 iv every 4 weeks and bevacizumab 10 mg/kg iv every 2 weeks. A treatment cycle consisted of 28 days. Results: Among 5 evaluable pts there were 1 partial response, 2 stable disease and 2 progressions, 3 pts were not evaluable because it is too early. Median number of administered cycles was 2 (2–6). The toxicity profile was particularly favourable with no G3/G4 haematological toxicity. Other most commonly seen toxicities were: nausea/vomiting (22%), mucositis (13%), diarrhea (9%). Proteinuria 1+ was reported in 3 cycles (13%). One patient with an early progression had also a G2 increase in blood pressure with a dilatative cardiomyopathy. Conclusions: The combination treatment resulted well tolerated and with a sufficient anti-tumor activity to warrant the continuing of enrolment. Updated efficacy and safety data will be presented. No significant financial relationships to disclose.