A Phase 2 Study Of Weekly Infusion Nab-paclitaxel (Paclitaxel Protein-bound Particles for Injectable Suspension) In Patients With Unresectable And Metastatic Uveal Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed evidence of metastatic/ unresectable uveal melanoma
- •Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension and is ≥10 mm by spiral CT scan
- •18 years or older
- •Eastern Cooperative Oncology Group(ECOG)performance status 0, or 1
- •No known HIV or Hepatitis B or C
- •Patients with brain metastasis are eligible for entry into the study
- •Patients must have normal organ/marrow function as defined below:
- •Absolute neutrophil count ≥ 1.5 x 109/L
- •Platelets ≥ 100,000 x 109/L
- •Hemoglobin ≥ 9.0 gm/100 ml
- •Total bilirubin ≤ 1.
- •In patients with Gilbert's disease the indirect bilirubin must be less than or equal to 4.
- •AST and ALT ≤ 2.5x upper limit of normal
- •Alkaline phosphatase ≤ 2.5x upper limit of normal, unless bone metastases is present in the absence of liver metastasis
- •Creatinine ≤ 1.8 mg/ml or calculated creatinine clearance > 50 mg ml.
- •Calcium <12 mg/dl when corrected for levels of serum albumen
- •Patients my have had up to one prior systemic therapy
排除标准
- •Chemotherapy or radiotherapy within 4 weeks prior to entering the study or failure to recover from adverse events due to agents administered more than 4 weeks earlier.
- •May not be receiving any other simultaneous investigational agents
- •No prior malignancy except for adequately treated basal cell cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years.
- •Patients who have serious infections or other major uncontrolled medical illnesses.
- •Patients who have significant psychiatric illness who in the opinion of the principal investigator would prevent adequate informed consent or render therapy unsafe.
- •Patients who are pregnant. Female patients of child bearing potential must have a negative serum pregnancy test and use adequate contraception protection while on study.
- •Peripheral neuropathy of > grade 2.
研究组 & 干预措施
nab-paclitaxel
Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
干预措施: nab-paclitaxel (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: up to 1 year following last treatment, for a total of approximately 5 years
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.
次要结局
- Progression-free Survival(up to 1 year following last treatment, for a total of approximately 5 years)
- Overall Survival(up to 1 year following last treatment, for a total of approximately 5 years)
研究者
Thomas Olencki
Principal Investigator
Ohio State University Comprehensive Cancer Center