Stage IV Melanoma Clinical Trial
Official title:
A Phase II Study of AZD2171 in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma
This phase II trial is studying how well AZD2171 works in treating patients with recurrent or stage IV melanoma. AZD2171 may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To assess the objective tumor response rate of AZD2171 administered to patients with
recurrent or metastatic malignant melanoma.
II. To assess the toxicity, median survival time, 1-year survival rate, response or stable
disease duration, time to disease progression and clinical benefit response of AZD2171
administered to patients with recurrent or metastatic malignant melanoma.
III. To measure baseline and post-treatment levels of angiogenic growth factors and
receptors, as well as circulating endothelial cells, and to explore the relationship between
these potential correlative endpoints and clinical outcome.
IV. To assess changes in blood flow and vessel permeability using dynamic contrast-enhanced
magnetic resonance imaging (DCE-MRI) pre- and post-treatment, and to explore the relationship
between these potential imaging endpoints and clinical outcome.
V. To look for polymorphisms of kdr/flk-1, and other genes in this pathway, by performing
pharmacogenetic analysis of pbmc's, and correlate genotype with VEGF levels and response to
therapy.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for survival.
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