A Phase I Trial of Carboplatin and Abraxane in Patients With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- Maximum Tolerated Dose (MTD) of Abraxane
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy such as paclitaxel albumin-stabilized nanoparticle formulation and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle formulation together with carboplatin may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects, the best way to give, and the best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with carboplatin in treating patients with advanced or metastatic solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of paclitaxel albumin-stabilized nanoparticle formulation given once weekly for 3 weeks when administered with carboplatin given once every 4 weeks.
- Determine the MTD of paclitaxel albumin-stabilized nanoparticle formulation given once every 3 weeks when administered with carboplatin given once every 3 weeks.
- Determine the MTD of paclitaxel albumin-stabilized nanoparticle formulation given in weeks 1 and 2 when administered with carboplatin given once every 3 weeks.
- Evaluate sequence-dependent effects on toxicity and pharmacokinetics in the combination of paclitaxel albumin-stabilized nanoparticle formulation and carboplatin.
Secondary
- Explore the antitumor activity of paclitaxel albumin-stabilized nanoparticle formulation given once weekly or once every 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Weekly Arm
Carboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle
干预措施: Carboplatin (Drug)
Weekly Arm
Carboplatin day 1, abraxane days 1, 8, 15 every 28 day cycle
干预措施: Abraxane (Drug)
Every 3 week Arm
Carboplatin day 1, abraxane day 1, every 21 day cycle
干预措施: Carboplatin (Drug)
Every 3 week Arm
Carboplatin day 1, abraxane day 1, every 21 day cycle
干预措施: Abraxane (Drug)
Arm C
Carboplatin day 1, abraxane day 1, 8 every 21 day cycle
干预措施: Carboplatin (Drug)
Arm C
Carboplatin day 1, abraxane day 1, 8 every 21 day cycle
干预措施: Abraxane (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Abraxane
时间窗: 28 days
To determine the maximum tolerated dose (MTD) of Abraxane weekly days 1, 8, 15 with a carboplatin dose of AUC=6 given on day 1 of a 28 day cycle
Maximum Tolerated Dose (MTD) of Abraxane given with Carboplatin
时间窗: 21 days
To determine the MTD of Abraxane given every 3 weeks with carboplatin given on day 1 of a 21 day cycle
Sequence-dependent toxicity
时间窗: 28 days
To determine if there is any correlation to toxicity based on the order Abraxane and carboplatin are adminstered
次要结局
未报告次要终点