NCT01533948

Axitinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed by Surgery

Predictive Markers of Response in a Phase II Trial of Axitinib in Advanced Melanoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well axitinib works in treating patients with melanoma that has spread to other places in the body or cannot be removed by surgery. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the overall response rate (ORR) to axitinib in advanced melanoma. This will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. SECONDARY OBJECTIVES: I. Evaluate toxicity of axitinib as a single agent. II. Determine progression-free survival and overall survival. III. Explore the utility of 3'-deoxy-3'-\[18F\] fluorothymidine-labeled positron emission tomography (FLT-PET) as a predictive marker for response and compare to standard radiographic imaging. TERTIARY OBJECTIVES: I. Examine the prognostic and predictive significance of circulating melanoma tumor cells. II. To examine whether functionally relevant polymorphisms in axitinib-related genes (vascular endothelial growth factor receptor \[VEGFR\] 1, VEGFR2 and VEGFR3) correlate with efficacy and toxicity of axitinib in advanced melanoma. OUTLINE: Patients receive axitinib orally (PO) twice daily (BID). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.

Conditions

• Extraocular Extension Melanoma
• Metastatic Intraocular Melanoma
• Recurrent Intraocular Melanoma
• Recurrent Melanoma
• Stage IIIA Intraocular Melanoma
• Stage IIIA Melanoma
• Stage IIIB Intraocular Melanoma
• Stage IIIB Melanoma
• Stage IIIC Intraocular Melanoma
• Stage IIIC Melanoma
• Stage IV Intraocular Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
DRUG	axitinib	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2012-02-16
• Last updated: 2018-05-09
• Results posted: 2018-05-09

Locations

1 site across 1 country: United States