Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study Of Weekly Infusion Nab-paclitaxel (Paclitaxel Protein-bound Particles for Injectable Suspension) In Patients With Unresectable And Metastatic Uveal Melanoma|
- Overall Response Rate [ Time Frame: up to 1 year following last treatment, for a total of approximately 5 years ] [ Designated as safety issue: No ]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.
- Progression-free Survival [ Time Frame: up to 1 year following last treatment, for a total of approximately 5 years ] [ Designated as safety issue: No ]Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel
- Overall Survival [ Time Frame: up to 1 year following last treatment, for a total of approximately 5 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2008|
|Study Completion Date:||April 2013|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
150 mg/m2 weekly for 3 of 4 weeks every 28 days.
- To evaluate the overall response rate of patients with unresectable, metastatic uveal melanoma treated with paclitaxel albumin-stabilized nanoparticle formulation.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738361
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Thomas E. Olencki, DO||Ohio State University Comprehensive Cancer Center|