Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma

Inclusion Criteria

• •LEVEL A (second line): after confirmed progression on standard first line treatment with dacarbazine.
• •LEVEL B (first line): when objective clinical response is observed in LEVEL A, patients will be included for first line treatment with bevacizumab
• •Histologically confirmed metastatic (unresectable) melanoma and with progressive disease
• •WHO performance status 0-2
• •Age \>18 years
• •Able to undergo outpatient treatment
• •Patients must have clinically and/or radiographically documented measurable disease according to RECIST criteria
• •At least 4 weeks since adjuvant interferon alpha
• •Recovered from prior chemotherapy
• •Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start. Biopsy or fine needle aspiration within 5 days prior to study treatment start. Central venous line placement must be inserted at least 5 days prior to treatment start.
• •Minimum required laboratory data:
• •Hematology: absolute granulocytes \> 1.0 x 109/L platelets \> 100 x 109/L Biochemistry: bilirubin \< 1.5 x upper normal limit serum creatinine within normal limits INR \< 1.5
• •Before patient registration/randomization, written informed consent must be given according to national and local regulations.