Abraxane and Avastin as Therapy for Patients With Malignant Melanoma, a Phase II Study
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
The study is an open-label, single arm multicenter Phase II study to evaluate the safety and
efficacy of the combination of Abraxane and Avastin as first-line therapy for patients with
unresectable metastatic malignant melanoma. The patient sample will be approximately 50
individuals, males and females 18 years of age or older with measurable metastatic melanoma.
Patients will be treated with Abraxane administered weekly for 3 weeks via a 30-minute IV
infusion at150 mg/m2 followed by 1 week rest (28-day cycle). Avastin will be administered in
a dose of 10 mg/kg every 2 weeks (without rest period). Patients will be evaluated for
disease progression every 2 months and those who do not have disease progression or
unacceptable toxicity will be offered ongoing therapy until they have progressive disease or
unacceptable toxicity.