NCT00243061

AZD2171 in Treating Patients With Recurrent or Stage IV Melanoma

A Phase II Study of AZD2171 in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acral Lentiginous Malignant Melanoma
• Ciliary Body and Choroid Melanoma, Medium/Large Size
• Ciliary Body and Choroid Melanoma, Small Size
• Extraocular Extension Melanoma
• Intraocular Melanoma
• Iris Melanoma
• Lentigo Maligna Malignant Melanoma
• Recurrent Melanoma
• Stage, Intraocular Melanoma
• Stage IV Melanoma
• Superficial Spreading Malignant Melanoma

Interventions

Type	Name	Description
DRUG	cediranib maleate	Given orally

Timeline

• Start date: 2006-01-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2005-10-21
• Last updated: 2018-08-27
• Results posted: 2015-06-23

Locations

1 site across 1 country: Canada