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Bevacizumab vs Dacarbazine in Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01705392
Recruitment Status : Terminated (Lack of financing of the study drug. Not sufficient financial support.)
First Posted : October 12, 2012
Last Update Posted : February 24, 2017
Sponsor:
Collaborators:
The Norwegian Melanoma Group
Norwegian Cancer Society
Information provided by (Responsible Party):
Haukeland University Hospital

Tracking Information
First Submitted Date  ICMJE October 8, 2012
First Posted Date  ICMJE October 12, 2012
Last Update Posted Date February 24, 2017
Actual Study Start Date  ICMJE January 2013
Actual Primary Completion Date February 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
Progression free survival [ Time Frame: Average of 6 months ]
Participants will be followed for the duration of the treatment and as long as they do not progress, an expected average of 6 months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
  • Response Rates according to RECIST [ Time Frame: Average 6 months ]
    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.
  • Disease control rate at 6 months [ Time Frame: 6 months ]
    Number of patient with complete response, partial response or stable disease at 6 months
  • Prevention of hypertension by beta blockers or ACE-inhibitors [ Time Frame: Average of 6 months ]
    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.
  • Overall survival [ Time Frame: Average og 12 months ]
    Participants will be followed until death for overall survival data, an expected average of 12 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bevacizumab vs Dacarbazine in Metastatic Melanoma
Official Title  ICMJE A Randomized Phase II Trial Comparing Bevacizumab Monotherapy With Dacarbazine (DTIC) in Treatment of Malignant Melanoma, Focusing on Angiogenic Markers and Prevention of Hypertension.
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Malignant Melanoma
  • Unresectable Malignant Melanoma
Intervention  ICMJE
  • Drug: Bevacizumab
    Bevacizumab 10 mg/kg q3w
    Other Name: Avastin
  • Drug: Propranolol
    Propranolol 80 mg x 1
    Other Names:
    • Inderal
    • Inderal retard
  • Drug: Enalapril
    Enalapril 5 mg x 1
    Other Names:
    • Renitec
    • Vasotec
  • Drug: Dacarbazine
    dacarbazine 1000 mg/m2 q3w
    Other Name: DTIC
Study Arms  ICMJE
  • Experimental: Bevacizumab plus propranolol
    Bevacizumab 10mg/kg q2w plus propranolol 80 mg x 1
    Interventions:
    • Drug: Bevacizumab
    • Drug: Propranolol
  • Experimental: Bevacizumab plus enalapril
    Bevacizumab 10mg/kg q2w plus enalapril 5 mg x 1
    Interventions:
    • Drug: Bevacizumab
    • Drug: Enalapril
  • Active Comparator: Dacarbazine
    Dacarbazine 1000mg/m2 q3w
    Intervention: Drug: Dacarbazine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 23, 2017)
2
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2012)
120
Actual Study Completion Date  ICMJE February 20, 2017
Actual Primary Completion Date February 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Previously treated or untreated, histologically confirmed, metastatic and unresectable melanoma with progressive disease
  • Both BRAF wild type patients as well as BRAF mutated patients are allowed. For BRAF mutated patients, BRAF targeting agents should be considered in first line if otherwise indicated and no contraindications exist.
  • WHO performance status 0-1
  • Age >18 years,
  • Known BRAF mutation
  • Able to undergo outpatient treatment
  • Patients must have clinically and/or radiographically documented measurable disease according to RECIST.
  • All radiology studies must be performed within 28 days prior to registration (35 days if negative).
  • At least 4 weeks since adjuvant interferon alpha
  • At least 4 weeks since 1st line treatment in case of metastasis
  • Major surgical procedure or significant traumatic injury > 28 days prior to study treatment start. Biopsy or fine needle aspiration > 2 days prior to study treatment start. Central venous line placement must be inserted at least 2 days prior to treatment start.
  • Only patients with irradiated and asymptomatic brain metastases and off dexamethasone are allowed.
  • Hematology: absolute granulocytes > 1.0 x 109/L
  • Platelets > 100 x 109/L
  • Bilirubin < 1.5 x upper normal limit
  • Serum creatinine < 1.5 x upper normal limits
  • LDH < 1.5 x upper normal limit
  • INR < 1.5
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • Before patient registration/randomization, written informed consent must be given according to national and local regulations.

Exclusion Criteria:

  • No previous DTIC
  • No previous anti-VEGF targeted therapies
  • No pregnant or lactating patients can be included
  • No clinical evidence of coagulopathy
  • No unstable angina pectoris
  • No AV-block II or III without pacemaker
  • No severe congestive heart failure
  • No untreated phaeochromocytoma
  • No severe bradycardia
  • No severe hypotension
  • No severe impairment of peripheral arterial circulation
  • No uncontrolled cardiac arrhythmia
  • No severe asthma or COPD
  • No uncontrolled diabetes mellitus
  • No Angioneurotic edema
  • No severe Aortic valve stenosis
  • No severe hypertrophic cardiomyopathy
  • No severe renal dysfunction
  • No patients on beta blockers/ ACE inhibitors by inclusion unable/unwilling to discontinue beta blockers/ ACE inhibitors and convert to other classes of antihypertensive drugs
  • No full-dose oral coumarin-derived anticoagulants (INR>1.5) or heparin, thrombolytic agents, or chronic, daily treatment with aspirin (>325 mg/day).
  • No uncontrolled hypertension
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01705392
Other Study ID Numbers  ICMJE 2012/910
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Haukeland University Hospital
Study Sponsor  ICMJE Haukeland University Hospital
Collaborators  ICMJE
  • The Norwegian Melanoma Group
  • Norwegian Cancer Society
Investigators  ICMJE
Principal Investigator: Oddbjorn Straume, MD PhD Department of Oncology, Haukeland University Hospital, Bergen, Norway
Study Director: Olav Mella, MD PhD Department of Oncology, Haukeland University Hospital, Bergen, Norway
PRS Account Haukeland University Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP