Vatalanib in Treating Patients With Metastatic Cutaneous Melanoma That Cannot be Removed by Surgery
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT00563823
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate as assessed by RECIST every 8 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom