Phase I Trial of Hepatic Arterial Infusion of Abraxane With a Pharmacokinetic Study in Advanced Solid Cancer Patients With Predominant Hepatic Metastases
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of HAI Abraxane
研究概览
简要总结
The goal of this clinical research study is find the highest tolerated dose of Abraxane (nab-paclitaxel) that can be given directly into the liver of patients with advanced cancer that has spread to the liver.
详细描述
The Study Drug:
Nab-paclitaxel is designed to block cancer cells from dividing, which may cause the cells to die.
Giving nab-paclitaxel directly into the liver may allow a higher dose of the drug to be given, while avoiding some of the side effects that occur when high doses of chemotherapy are given other ways (for example, by vein into an arm).
Study Drug Dose Level:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 9 groups of 6 participants will be enrolled in Part 1 of the study, and up to 18 participants will be enrolled in Part 2. If you are enrolled in Part 1, the dose of the study drug you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of the study drug. Each new group will receive a higher dose of the study drug than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug is found. If you are enrolled in Part 2, you will receive the study drug at the highest dose that was tolerated in the Part 1 portion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Pathologically confirmed diagnosis of advanced malignancy and liver involvement as predominant site of metastasis.
- •An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Adequate end-organ function as follows: Absolute neutrophil count (ANC) > or = 1500/mm3, Platelets > or = 100,000/mm3, Creatinine < or = 2.0 mg/dL or the calculated Glomerular filtration rate (GFR) > or = 40 mL/min if Creatinine > 2.0 mg/dL, ALT < or = 5 times upper limits of normal, Hb > 9.0 and Bilirubin < or = 2.0 mg/dL.
- •Refractory to standard cancer therapy or who have no conventional therapy that produces a complete response rate of at least 10% or an increase in survival of at least 3 months.
- •Ability to fully comprehend and willingness to sign the Institutional Review Board (IRB) approved informed consent
- •Full recovery from any previous therapy and ability to receive cytotoxic agents.
- •Patient is 18 years of age or older
排除标准
- •Clinically significant ascites.
- •Pregnant or breastfeeding females. Women of childbearing potential should be advised to avoid becoming pregnant and men to not father a child while receiving treatment. Women of childbearing potential must have a negative pregnancy test.
- •Hypersensitivity to Abraxane
- •Untreatable bleeding diathesis
- •Evidence of portal vein thrombosis and clinically significant peripheral vascular disease
- •Neuropathy of grade 2 or higher
- •A known history of central nervous system (CNS) metastasis unless the patients are neurologically stable after treatment with surgery and/or radiation therapy
- •If the patient progressed on abraxane previously they will not be eligible for the dose escalation portion or the PK studies only. These patients can be included in the dose expansion portion of the trial.
研究组 & 干预措施
HAI Abraxane MTD
Dose escalation beginning Day 1, Cycle 2 dose level 180 mg/m^2 for maximum tolerated dose (MTD) of Hepatic Arterial Infusion of Abraxane (HAI Abraxane) following same dose intravenous Abraxane in Cycle 1 of 21 day cycle.
干预措施: HAI Abraxane (Drug)
HAI Abraxane MTD
Dose escalation beginning Day 1, Cycle 2 dose level 180 mg/m^2 for maximum tolerated dose (MTD) of Hepatic Arterial Infusion of Abraxane (HAI Abraxane) following same dose intravenous Abraxane in Cycle 1 of 21 day cycle.
干预措施: Hepatic Artery Catheter (Procedure)
HAI Abraxane MTD
Dose escalation beginning Day 1, Cycle 2 dose level 180 mg/m^2 for maximum tolerated dose (MTD) of Hepatic Arterial Infusion of Abraxane (HAI Abraxane) following same dose intravenous Abraxane in Cycle 1 of 21 day cycle.
干预措施: IV Abraxane (Drug)
HAI Abraxane Expansion
HAI Abraxane dose expansion at MTD or dose level 3 (260 mg/m^2) if MTD not defined.
干预措施: HAI Abraxane (Drug)
HAI Abraxane Expansion
HAI Abraxane dose expansion at MTD or dose level 3 (260 mg/m^2) if MTD not defined.
干预措施: Hepatic Artery Catheter (Procedure)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of HAI Abraxane
时间窗: Assessments every 3 week cycle (21 days)
MTD is highest dose level in which 6 patients with at most 1 patient experiencing a dose limiting toxicity (DLT). Dose escalation continues until DLT is defined or until dose level 4 is completed. DLT defined during first cycle of treatment.
次要结局
未报告次要终点