Melanoma (Skin) Clinical Trial
Official title:
A Phase II Study to Evaluate the Efficacy and Safety of PTK787 in Patients With Metastatic Cutaneous Melanoma
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.
;
Masking: Open Label, Primary Purpose: Treatment
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