A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma

An Open-label Study to Assess the Anti-tumor Activity of Avastin in Combination With Fotemustine as First-line Therapy in Patients With Metastatic Melanoma

This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously[IV]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Inclusion Criteria:

• cutaneous malignant melanoma;
• advanced, inoperable stage IV melanoma;
• measurable and/or evaluable sites of metastases.

Exclusion Criteria:

• prior chemotherapy and/or IFN/IL2 based immunotherapy for metastatic disease;
• prior malignancies within past 5 years, with the exception of cured non-melanoma skin cancer, or in situ cancer of cervix;
• clinically significant cardiovascular disease;
• ongoing treatment with aspirin (>325mg/day) or other medications known to predispose to gastrointestinal ulceration.