Axitinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed by Surgery
Extraocular Extension Melanoma
Metastatic Intraocular Melanoma
Recurrent Intraocular 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
Other: laboratory biomarker analysis
|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: Up to 30 days ] [ Designated as safety issue: No ]Continuous variables will be summarized with commonly used statistics (mean, standard deviation, median, etc.), with sub-group associations tested using the Wilcoxon Rank Sum test.
- Incidence of toxicity of axitinib as a single agent as assessed by the severity of adverse effects by NCI CTCAE version 4 [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]Continuous variables will be summarized with commonly used statistics (mean, standard deviation, median, etc.), with sub-group associations tested using the Wilcoxon Rank Sum test.
- Progression-free survival (PFS) [ Time Frame: From the date of study enrollment to the first observation of progressive disease or death, assessed up to 30 days ] [ Designated as safety issue: No ]The distribution will be described using Kaplan-Meier and proportional hazards methods.
- Overall survival (OS) [ Time Frame: From the date of study enrollment to the time of death from any cause, assessed up 30 days ] [ Designated as safety issue: No ]The distribution will be described using Kaplan-Meier and proportional hazards methods.
- Change in response as a function of standardized uptake value (SUV) readings by FLT-PET and circulative tumor cells [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]Models will be fit using logistic regression methods. Goodness of fit for these models will be assessed using the Hosmer-Lemeshow test. The predictive accuracy of the models will be described using the area under the receiver operating characteristic curve (the so-called "c" statistic). Generally, models with c >= 0.8 are considered to have good predictive ability. The association SUV measurements and OS/PFS time to event will be considered using Kaplan Meier and proportional hazards methods as discussed above.
|Study Start Date:||January 2012|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (axitinib)
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
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|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Matuesz Opyrchal, MD||Roswell Park Cancer Institute|