Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma

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 Inclusion Criteria: 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. Exclusion Criteria: No pregnant or lactating patients can be included No prior interferon alpha or IL-2 for metastatic disease No more than 1 prior chemotherapy regimen for metastatic disease No clinical evidence of coagulopathy No brain metastases No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No history of thrombosis No full-dose oral coumarin-derived anticoagulants (INR>1.5) or heparin, thrombolytic agents, or chronic, daily treatment with aspirin (>325 mg/day) No non-steroidal anti-inflammatory medications (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases) No uncontrolled hypertension Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial