RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with metastatic cutaneous melanoma that cannot be removed by surgery.
OBJECTIVES: Primary * To determine the response rate in patients with unresectable metastatic cutaneous melanoma treated with vatalanib. Secondary * To determine the time to progression in these patients. * To determine the 6-month and 1-year survival of these patients. * To determine the overall survival of these patients. * To determine the safety and toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral vatalanib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed at 8 weeks and then periodically thereafter.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Response rate as assessed by RECIST every 8 weeks
Time to progression
Survival at 6 months and 1 year
Overall survival
Toxicity as assessed by NCI CTCAE v3.0 at 2 weeks and then every 4 weeks
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