Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma

August 26, 2015 updated by: Oddbjørn Straume, MD PhD, Haukeland University Hospital

Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma and Predictive Value of Angiogenic Markers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In Norway, cutaneous malignant melanoma is the second most frequent and the most frequent cancer type in middle-aged (30-54 years) females and males, respectively, and the incidence has six-doubled during the last 30 years. Median survival for patients with metastatic melanoma is 6 months.

Many agents have been investigated for anti-tumor effect in melanoma, but there is no accepted standard therapy. Biochemotherapy, combining cytotoxic drugs with Interleukin-2 or Interferon alpha, has not been shown to be superior to single agent Dacarbazine (DTIC), which is regarded to be the most active agent. Other biological approaches like vaccination are currently under investigation, but still no efficient treatment for metastatic melanoma is available. DTIC induces objective remission in 20% of the patients, but without significant impact on survival.

The need of a new and effective treatment for the group of melanoma patients is urgently needed. This will be the first study to assess response rates of bevacizumab monotherapy in first line treatment of metastatic melanoma. In addition there will be a major focus on the identification of predictive biomarkers of bevacizumab efficacy.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5020
        • Department of Oncology, Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

LEVEL A (second line): after confirmed progression on standard first line treatment with dacarbazine.

LEVEL B (first line): when objective clinical response is observed in LEVEL A, patients will be included for first line treatment with bevacizumab

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Active drug
Drug: Bevacizumab
Anti angiogenesis treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Response rates
Time Frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression
Time Frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
Overall survival
Time Frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years.
Safety data
Time Frame: Evaluated by consultations every 12 weeks, later every 6 monts. Up to 10 years.
CTCAEv2 side effects
Evaluated by consultations every 12 weeks, later every 6 monts. Up to 10 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Collaborators

Hoffmann-La Roche
Norwegian Cancer Society

Investigators

  • Principal Investigator: Oddbjorn Straume, MD, PhD, Department of Oncology, Haukeland University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

August 31, 2005

Study Record Updates

Last Update Posted (Estimate)

August 27, 2015

Last Update Submitted That Met QC Criteria

August 26, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSD-11933
  • 94070/013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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