NCT01705392

Bevacizumab vs Dacarbazine in Metastatic Melanoma

A Randomized Phase II Trial Comparing Bevacizumab Monotherapy With Dacarbazine (DTIC) in Treatment of Malignant Melanoma, Focusing on Angiogenic Markers and Prevention of Hypertension.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Malignant Melanoma
• Unresectable Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Bevacizumab	Bevacizumab 10 mg/kg q3w
DRUG	Propranolol	Propranolol 80 mg x 1
DRUG	Enalapril	Enalapril 5 mg x 1
DRUG	Dacarbazine	dacarbazine 1000 mg/m2 q3w

Timeline

• Start date: 2013-01-01
• Primary completion: 2017-02-20
• Completion: 2017-02-20
• First posted: 2012-10-12
• Last updated: 2017-02-24

Locations

1 site across 1 country: Norway