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Bevacizumab vs Dacarbazine in Metastatic Melanoma

NCT01705392 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-02-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • The Norwegian Melanoma Group

    collaborator UNKNOWN

  • Norwegian Cancer Society

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Oddbjorn Straume, MD PhD · Department of Oncology, Haukeland University Hospital, Bergen, Norway

  • Olav Mella, MD PhD · Department of Oncology, Haukeland University Hospital, Bergen, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-02-20
Completion
2017-02-20

Countries

  • Norway

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01705392 on ClinicalTrials.gov