RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with metastatic melanoma of the eye that cannot be removed by surgery.
OBJECTIVES: Primary * To evaluate the overall response rate of patients with unresectable, metastatic uveal melanoma treated with paclitaxel albumin-stabilized nanoparticle formulation. Secondary * To determine the median progression-free survival of patients treated with this regimen. * To determine the overall survival of patients treated with this regimen. OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 8 weeks for 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Overall Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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.
Time frame: up to 1 year following last treatment, for a total of approximately 5 years
Progression-free Survival
Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel
Time frame: up to 1 year following last treatment, for a total of approximately 5 years
Overall Survival
Overall Survival is defined as the time from the start of treatment (study day 1) until death to the date of his or her death. If the subject has not died, survival time will be censored on last date the subject was known to be alive.
Time frame: up to 1 year following last treatment, for a total of approximately 5 years
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