Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma

NCT00139360 | Completed Phase 2

• 2 other identifiers: NSD-1193394070/013
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy as measured by objective tumor response of first-line treatment of metastatic melanoma with bevacizumab monotherapy

Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• Clinical Response rates

  Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.

Secondary Outcomes (3)

• Time to progression

  Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.

• Overall survival

  Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.

• Safety data

  Evaluated by consultations every 12 weeks, later every 6 monts. Up to 10 years.

Study Arms (1)

1

EXPERIMENTAL

Active drug

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

Anti angiogenesis treatment

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed metastatic (unresectable) melanoma and with progressive disease
• WHO performance status 0-2
• Age \>18 years
• Able to undergo outpatient treatment
• Patients must have clinically and/or radiographically documented measurable disease according to RECIST criteria
• At least 4 weeks since adjuvant interferon alpha
• Recovered from prior chemotherapy
• Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start. Biopsy or fine needle aspiration within 5 days prior to study treatment start. Central venous line placement must be inserted at least 5 days prior to treatment start.
• Minimum required laboratory data:
• Hematology: absolute granulocytes \> 1.0 x 109/L platelets \> 100 x 109/L Biochemistry: bilirubin \< 1.5 x upper normal limit serum creatinine within normal limits INR \< 1.5
• Before patient registration/randomization, written informed consent must be given according to national and local regulations.

You may not qualify if:

• No pregnant or lactating patients can be included
• No prior interferon alpha or IL-2 for metastatic disease
• No more than 1 prior chemotherapy regimen for metastatic disease
• No clinical evidence of coagulopathy
• No brain metastases
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No history of thrombosis
• No full-dose oral coumarin-derived anticoagulants (INR\>1.5) or heparin, thrombolytic agents, or chronic, daily treatment with aspirin (\>325 mg/day)
• No non-steroidal anti-inflammatory medications (those known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
• No uncontrolled hypertension
• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• Norwegian Cancer Society: collaborator
• Hoffmann-La Roche: collaborator

Study Sites (1)

Department of Oncology, Haukeland University Hospital

Bergen, 5020, Norway

Location

Related Publications (2)

• Schuster C, Akslen LA, Straume O. Expression of Heat Shock Protein 27 in Melanoma Metastases Is Associated with Overall Response to Bevacizumab Monotherapy: Analyses of Predictive Markers in a Clinical Phase II Study. PLoS One. 2016 May 11;11(5):e0155242. doi: 10.1371/journal.pone.0155242. eCollection 2016.

  PMID: 27166673 DERIVED

• Schuster C, Eikesdal HP, Puntervoll H, Geisler J, Geisler S, Heinrich D, Molven A, Lonning PE, Akslen LA, Straume O. Clinical efficacy and safety of bevacizumab monotherapy in patients with metastatic melanoma: predictive importance of induced early hypertension. PLoS One. 2012;7(6):e38364. doi: 10.1371/journal.pone.0038364. Epub 2012 Jun 15.

  PMID: 22719881 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Oddbjorn Straume, MD, PhD

  Department of Oncology, Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: August 31, 2005
• Study Start: May 1, 2005
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 27, 2015

Record last verified: 2015-08

Locations

NO (1)