Vatalanib in Treating Patients With Metastatic Cutaneous Melanoma That Cannot be Removed by Surgery
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study to Evaluate the Efficacy and Safety of PTK787 in Patients With Metastatic Cutaneous Melanoma|
- Response rate as assessed by RECIST every 8 weeks [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Survival at 6 months and 1 year [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTCAE v3.0 at 2 weeks and then every 4 weeks [ Designated as safety issue: Yes ]
|Study Start Date:||February 2006|
|Study Completion Date:||October 2010|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
- To determine the response rate in patients with unresectable metastatic cutaneous melanoma treated with vatalanib.
- 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.
|Cambridge, England, United Kingdom, CB2 2QQ|
|Leicester Royal Infirmary|
|Leicester, England, United Kingdom, LE1 5WW|
|Study Chair:||Pippa Corrie, PhD, FRCP||Cambridge University Hospitals NHS Foundation Trust|