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

Phase 2
18 Years
Not Enrolling
Metastatic Melanoma

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Trial Information

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

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.

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

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Response rates

Outcome Time Frame:


Safety Issue:


Principal Investigator

Oddbjorn Straume, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, Haukeland University Hospital


Norway: Norwegian Medicines Agency

Study ID:




Start Date:

May 2005

Completion Date:

July 2011

Related Keywords:

  • Metastatic Melanoma
  • Melanoma