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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Response Rate (Complete Response + Partial Response) to Axitinib as Assessed Using RECIST Version 1.1