Axitinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed By Surgery
This phase II trial studies how well axitinib works in treating patients with melanoma that is metastatic or cannot be removed by surgery. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Stage IIIA Melanoma
Stage IIIB Melanoma
Stage IIIC Melanoma
Stage IV Melanoma
Other: laboratory biomarker analysis
Other: pharmacogenomic studies
Procedure: positron emission tomography
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Predictive Markers of Response in a Phase II Trial of Axitinib in Advanced Melanoma|
- Overall response rate (complete response + partial response) to axitinib as assessed using RECIST version 1.1 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Toxicity of axitinib as a single agent as assessed by the severity of adverse effects by NCI CTCAE version 4 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Progression-free survival [ Time Frame: From the date of study enrollment to the first observation of progressive disease or death, assessed up to 1 year ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From the date of study enrollment to the time of death from any cause, assessed up to 1 year ] [ Designated as safety issue: No ]
- Change in response as a function of standardized uptake value (SUV) readings and circulative tumor cells (CTC) by FLT-PET [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzyme inhibitor)
Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: pharmacogenomic studies
Other Name: Pharmacogenomic StudyOther: 3'-deoxy-3'-[18F]fluorothymidine
Other Name: 18F-FLTProcedure: positron emission tomography
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.
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533948
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Roswell Park 877-275-7724 AskRPCI@roswellpark.org|
|Principal Investigator: Nikhil I. Khushalani|
|Principal Investigator:||Nikhil Khushalani||Roswell Park Cancer Institute|