A Two Arm Phase I Dose Escalation Trial of Vinflunine With Erlotinib or Pemetrexed in Refractory Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) of vinflunine and pemetrexed disodium
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as vinflunine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib and pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vinflunine together with erlotinib or pemetrexed may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vinflunine when given together with erlotinib or pemetrexed in treating patients with unresectable or metastatic solid tumors.
详细描述
OBJECTIVES:
Primary
- Define the maximum tolerated dose (MTD) of vinflunine and pemetrexed disodium in patients with unresectable or metastatic solid tumors.
- Define the MTD of vinflunine and erlotinib hydrochloride in these patients.
Secondary
- Determine the preliminary safety and efficacy (reported descriptively per patient response; tumor specific response rate reported if applicable) of these regimens.
- Correlate CYP3A4 activity, as measured by midazolam clearance, with vinflunine plasma clearance.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
Pemetrexed, Vinflunine, Folate, B12, Dexamethasone, Ondansetron, Midazolam
干预措施: pemetrexed disodium (Drug)
Arm A
Pemetrexed, Vinflunine, Folate, B12, Dexamethasone, Ondansetron, Midazolam
干预措施: vinflunine (Drug)
Arm B
Vinflunine, Erlotinib, Ondansetron, Midazolam
干预措施: erlotinib hydrochloride (Drug)
Arm B
Vinflunine, Erlotinib, Ondansetron, Midazolam
干预措施: vinflunine (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) of vinflunine and pemetrexed disodium
时间窗: 1 year
The MTD is defined as the dose cohort where approximately 0.20 of patients experience DLT. Standard "groups of three" phase I dose escalation design will be used in each arm. Each dose cohort will accrue a minimum of three patients.The estimated MTD is the dose level below the dose that induced dose limiting toxicity (DLT) in one third or more of patients
Maximum tolerated dose (MTD) of vinflunine and continuously dosed erlotinib
时间窗: 1 year
The MTD is defined as the dose cohort where approximately 0.20 of patients experience DLT. Standard "groups of three" phase I dose escalation design will be used in each arm. Each dose cohort will accrue a minimum of three patients.The estimated MTD is the dose level below the dose that induced dose limiting toxicity (DLT) in one third or more of patients
Maximum tolerated dose (MTD) of vinflunine and intermittently dosed erlotinib
时间窗: 1 year
The MTD is defined as the dose cohort where approximately 0.20 of patients experience DLT. Standard "groups of three" phase I dose escalation design will be used in each arm. Each dose cohort will accrue a minimum of three patients.The estimated MTD is the dose level below the dose that induced dose limiting toxicity (DLT) in one third or more of patients
次要结局
未报告次要终点