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Brief Title: Bevacizumab vs Dacarbazine in Metastatic Melanoma
Official Title: A Randomized Phase II Trial Comparing Bevacizumab Monotherapy With Dacarbazine (DTIC) in Treatment of Malignant Melanoma, Focusing on Angiogenic Markers and Prevention of Hypertension.
Study ID: NCT01705392
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Haukeland University Hospital, Bergen, , Norway
Name: Oddbjorn Straume, MD PhD
Affiliation: Department of Oncology, Haukeland University Hospital, Bergen, Norway
Role: PRINCIPAL_INVESTIGATOR
Name: Olav Mella, MD PhD
Affiliation: Department of Oncology, Haukeland University Hospital, Bergen, Norway
Role: STUDY_DIRECTOR