The purpose of this study is to compare efficacy of bevacizumab monotherapy with standard chemotherapy (DTIC) in patients with metastatic malignant melanoma. In addition, we want to evaluate the predictive value of a set biomarkers associated with vascular endothelial growth factor (VEGF) dependent angiogenesis. Also, we aim to identify mechanisms causing acquired resistance to treatment with bevacizumab and escape mechanisms caused by other angiogenic growth factors than VEGF. Finally, we want to analyze safety and influence on outcome variables by primary prevention of bevacizumab induced hypertension by low dose beta blockers in comparison with an ACE inhibitor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Bevacizumab 10 mg/kg q3w
Propranolol 80 mg x 1
Enalapril 5 mg x 1
dacarbazine 1000 mg/m2 q3w
Haukeland University Hospital
Bergen, Norway
Progression free survival
Participants will be followed for the duration of the treatment and as long as they do not progress, an expected average of 6 months
Time frame: Average of 6 months
Response Rates according to RECIST
Participants will be followed for the duration of the treatment with CT scans for response evaluation every 2 months for an expected average of 6 months.
Time frame: Average 6 months
Disease control rate at 6 months
Number of patient with complete response, partial response or stable disease at 6 months
Time frame: 6 months
Prevention of hypertension by beta blockers or ACE-inhibitors
Safety and influence on outcome variables by primary prevention of bevacizumab induced hypertension, by low dose beta blockers (propranolol 80 mg x 1), in comparison with an ACE inhibitor (enalapril 5 mg x 1). Patients will be monitored as during active treatment with anti hypertensive drugs and bevacizumab for an average of 6 months.
Time frame: Average of 6 months
Overall survival
Participants will be followed until death for overall survival data, an expected average of 12 months
Time frame: Average og 12 months
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