Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haukeland University Hospital
• Collaborators: Hoffmann-La Roche; Norwegian Cancer Society
• Treatments: Bevacizumab

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