Axitinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed by Surgery (NCT01533948) | Clinical Trial Compass
TerminatedPhase 2
Axitinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed by Surgery
Stopped: low accrual
United States25 participantsStarted 2012-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically proven melanoma (including uveal) that is advanced (metastatic) or unresectable
* Measurable disease
* No more than two prior regimens (0-2) of systemic therapy for metastatic or recurrent disease; therapy (systemic or radiotherapy) administered in the neo-adjuvant or adjuvant setting for previously localized disease is permitted, provided it was completed more than 3 months prior to enrollment; palliative radiotherapy is permitted provided it is completed \>= 2 weeks prior to study therapy initiation and there is at least one measurable lesion outside the radiation field; at least 2 weeks since the end of prior systemic treatment, radiotherapy, or surgical procedure with resolution of all treatment-related toxicity to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =\< 1 or back to baseline except for alopecia or hypothyroidism
* Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* Life expectancy \>= 12 weeks
* Absolute neutrophil count (ANC) \>= 1500 cells/mm\^3
* Platelets \>= 75,000 cells/mm\^3
* Hemoglobin \>= 9.0 g/dL
* Creatinine =\< 1.5 X upper limit normal (ULN) or calculated creatinine clearance \>= 60 mL/min
* Bilirubin =\< 1.5 X ULN
* Transaminase =\< 2.5 X ULN (for documented liver metastases, transaminase up to 5 X ULN is permitted)
* Random urinary protein/creatinine ratio \< 2
* Have the ability to swallow and retain oral medicati…
What they're measuring
1
Overall Response Rate (Complete Response + Partial Response) to Axitinib as Assessed Using RECIST Version 1.1