A clinical phase II trial to compare the efficacy of Bevacizumab monotherapy with standard chemotherapy (dacarbazine) in metastatic melanoma.

• Conditions: Previously treated or untreated histologically confirmed metastatic and unresectable melanoma with radiological (RECIST), clinical or biochemical progressive disease.; MedDRA version: 14.1Level: PTClassification code 10027480Term: Metastatic malignant melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001020-35-NO
• Lead Sponsor: Helse Bergen HF, Haukeland University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-12
• Last Update Posted: 10 December 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Previously treated or untreated histologically confirmed metastatic and unresectable melanoma with radiological (RECIST), clinical or biochemical progressive disease
- No previous DTIC
- No previous anti-VEGF targeted therapies
- WHO performance status 0-1
- Age >18 years,
- No pregnant or lactating patients can be included.
- 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
- Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start. Biopsy or fine needle aspiration within 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 dexametasone 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
- No clinical evidence of coagulopathy
- No unstable angina pectoris
- Before patient registration/randomization, written informed consent must be given according to national and local
- 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 regulations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Propranolol contraindications:
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
- Enalapril contraindications:
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified