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