Status:
COMPLETED
Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma
Lead Sponsor:
Haukeland University Hospital
Collaborating Sponsors:
Norwegian Cancer Society
Hoffmann-La Roche
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To determine the efficacy as measured by objective tumor response of first-line treatment of metastatic melanoma with bevacizumab monotherapy
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 du...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00139360
Start Date
May 1 2005
End Date
July 1 2011
Last Update
August 27 2015
Active Locations (1)
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1
Department of Oncology, Haukeland University Hospital
Bergen, Norway, 5020