Predictive Markers of Response in a Phase II Trial of Axitinib in Advanced Melanoma

•  Histologically or cytologically proven melanoma that is advanced (metastatic) or unresectable
• Have the ability to swallow and retain oral medication
• No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.  The baseline systolic blood pressure readings must be < 90 mm Hg.  Patients whose hypertension is controlled by antihypertensive  therapies are eligible. 

Exclusion: 

•  Major surgery less than 4 weeks or radiation therapy less than 2 weeks of starting the study treatment.  Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated. 
• Significant history of bleeding events within 6 months prior to registration. 
• Gastrointestinal abnormalities including:  inability to take oral medication, requiring sustenance intravenously, prior surgical procedures affecting absorption including total gastric resection; segmental small bowel or colon resection is permitted; treatment for active peptic ulcer disease in the past 6 months; active gastrointestinal bleeding, unrelated to cancer, in the past 6 months without evidence of resolution documented by endoscopy or colonoscopy; malabsorption syndromes; and history of GI perforation within prior 12 months.