Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborators:
The Norwegian Cancer Association
Hoffmann-La Roche
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00139360
First received: August 30, 2005
Last updated: July 29, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Metastatic Melanoma
Drug: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma and Predictive Value of Angiogenic Markers

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Clinical Response rates [ Time Frame: continous ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: continous ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: continous ] [ Designated as safety issue: No ]
  • Safety data [ Time Frame: continous ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: May 2005
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Active drug
Drug: Bevacizumab
Anti angiogenesis 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139360

Locations
Norway
Department of Oncology, Haukeland University Hospital
Bergen, Norway, 5020
Sponsors and Collaborators
Haukeland University Hospital
The Norwegian Cancer Association
Hoffmann-La Roche
Investigators
Principal Investigator: Oddbjorn Straume, MD, PhD Department of Oncology, Haukeland University Hospital
  More Information

No publications provided by Haukeland University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oddbjorn Straume, MD, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00139360     History of Changes
Other Study ID Numbers: NSD-11933, 94070/013
Study First Received: August 30, 2005
Last Updated: July 29, 2011
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014