Axitinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed by Surgery
|ClinicalTrials.gov Identifier: NCT01533948|
Recruitment Status : Terminated (low accrual)
First Posted : February 16, 2012
Results First Posted : May 9, 2018
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: axitinib Other: laboratory biomarker analysis||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Predictive Markers of Response in a Phase II Trial of Axitinib in Advanced Melanoma|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Treatment (axitinib)
Patients receive axitinib PO BID. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
- Overall Response Rate (Complete Response + Partial Response) to Axitinib as Assessed Using RECIST Version 1.1 [ Time Frame: Up to 30 days ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Number of Patients That Experienced at Least One Grade 3 Adverse Event [ Time Frame: Up to 30 days ]Number of patients that experienced at least one grade 3 toxicity regardless of attribution. Incidence of toxicity of axitinib as a single agent as assessed by the severity of adverse effects by NCI CTCAE version 4. Please refer to the adverse event reporting for more detail.
- Median Progression-free Survival (PFS) [ Time Frame: From the date of study enrollment to the first observation of progressive disease or death within 30 days after last dose of study drug ]The distribution will be described using Kaplan-Meier and proportional hazards methods. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Median Overall Survival (OS) [ Time Frame: From the date of study enrollment to the time of death within 30 days after last dose of study drug ]The distribution will be described using Kaplan-Meier and proportional hazards methods.
- The Baseline Circulative Tumor Cells Value of Responders [ Time Frame: Baseline ]The baseline Circulative tumor Cells values of patients with response to treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. CTC were evaluated at baseline, response was assessed up to 30 days.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533948
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Matuesz Opyrchal, MD||Roswell Park Cancer Institute|