Bevacizumab vs Dacarbazine in Metastatic Melanoma

Conditions

• Metastatic Malignant Melanoma
• Unresectable Malignant Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — DRUG
  Bevacizumab 10 mg/kg q3w
• Propranolol — DRUG
  Propranolol 80 mg x 1
• Enalapril — DRUG
  Enalapril 5 mg x 1
• Dacarbazine — DRUG
  dacarbazine 1000 mg/m2 q3w

Study Details

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.

Key Dates

First listed

Oct 12, 2012

Start date

Jan 31, 2013

Status verified

Feb 2017

Primary completion

Feb 20, 2017

Completion

Feb 20, 2017

Study Design

Enrollment

2 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Bevacizumab plus propranolol
  Bevacizumab 10mg/kg q2w plus propranolol 80 mg x 1
• Experimental: Bevacizumab plus enalapril
  Bevacizumab 10mg/kg q2w plus enalapril 5 mg x 1
• Active Comparator: Dacarbazine
  Dacarbazine 1000mg/m2 q3w

Primary Outcome Measure

Progression free survival [ Time Frame: Average of 6 months ]