Stage IV Melanoma Clinical Trial
Official title:
Predictive Markers of Response in a Phase II Trial of Axitinib in Advanced Melanoma
This phase II trial studies how well axitinib works in treating patients with melanoma that has spread to other places in the body or cannot be removed by surgery. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the overall response rate (ORR) to axitinib in advanced melanoma. This will
be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
SECONDARY OBJECTIVES:
I. Evaluate toxicity of axitinib as a single agent. II. Determine progression-free survival
and overall survival. III. Explore the utility of 3'-deoxy-3'-[18F] fluorothymidine-labeled
positron emission tomography (FLT-PET) as a predictive marker for response and compare to
standard radiographic imaging.
TERTIARY OBJECTIVES:
I. Examine the prognostic and predictive significance of circulating melanoma tumor cells.
II. To examine whether functionally relevant polymorphisms in axitinib-related genes
(vascular endothelial growth factor receptor [VEGFR] 1, VEGFR2 and VEGFR3) correlate with
efficacy and toxicity of axitinib in advanced melanoma.
OUTLINE:
Patients receive axitinib orally (PO) twice daily (BID). Courses repeat every 4 weeks in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
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