Melanoma (Skin) Clinical Trial
Official title:
A Phase I/II Trial of Nexavar, Avastin and Eloxatin in Patients With Metastatic Malignant Melanoma
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth
in different ways. Some block the ability of tumor cells to grow and spread. Others find
tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may
also stop the growth of malignant melanoma by blocking blood flow to the tumor. Drugs used
in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor
cells, either by killing the cells or by stopping them from dividing. Giving sorafenib
together with bevacizumab and oxaliplatin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side-effects and best dose of sorafenib when
given together with bevacizumab and oxaliplatin and to see how well it works in treating
patients with metastatic malignant melanoma.
OBJECTIVES:
- To determine the maximum tolerated dose of sorafenib tosylate when administered with
bevacizumab and oxaliplatin.
- To determine the effect of this treatment regimen on the complete and partial response
rate in patients with metastatic melanoma.
- To determine the effect of this treatment regimen on the progression-free and overall
survival of patients with metastatic melanoma.
OUTLINE: This is a phase I dose-escalation study of sorafenib tosylate followed by a phase
II study.
- Phase I: Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2
hours on day 1. Patients also receive oral sorafenib tosylate twice daily on days 1-14.
Treatment repeats every 2 weeks in the absence of disease progression or unacceptable
toxicity.
- Phase II: Patients receive sorafenib tosylate at the maximum tolerated dose and
bevacizumab and oxaliplatin as in phase I.
After completion of study therapy, patients are followed for at least 5 years.
;
Primary Purpose: Treatment
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