A Phase I Evaluation of the Combination of Pegylated Liposomal Doxorubicin (Doxil®) With PS-341 in Patients With Refractory Hematologic and Solid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) of PS-341 in combination with Doxil (Phase I)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving doxorubicin hydrochloride liposome together with bortezomib may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of bortezomib when given together with doxorubicin hydrochloride liposome and to see how well they work in treating patients with refractory hematologic cancer or malignant solid tumor or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of bortezomib when administered with pegylated doxorubicin hydrochloride liposome in patients with refractory hematologic or solid tumor malignancies. (Phase I [closed to accrual as of 10/15/2007])
- Determine the dose-limiting toxicity of this regimen in these patients. (Phase I [closed to accrual as of 10/15/2007])
- Determine the response rate in patients with metastatic breast cancer treated with this regimen. (Phase II)
Secondary
- Determine the response in patients with hematologic or solid tumor malignancies treated with this regimen. (Phase I [closed to accrual as of 10/15/2007])
- Determine the time to disease progression in patients with metastatic breast cancer treated with this regimen. (Phase II)
- Obtain further evidence of the safety of this regimen in patients with metastatic breast cancer. (Phase II)
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
Part 1
Doxil + PS-341
干预措施: PS-341 (Drug)
Part 1
Doxil + PS-341
干预措施: Doxil (Drug)
Part 2
Doxil + Velcade
干预措施: Doxil (Drug)
Part 2
Doxil + Velcade
干预措施: Velcade (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) of PS-341 in combination with Doxil (Phase I)
时间窗: 1 year
When the current dose level exceeds the MTD, the preceding dose-level will be considered to be the MTD if there have been six patients treated at that dose level. Otherwise, 3 additional patients will be treated at the presumed MTD. No further dose escalation will occur. MTD, like dose limiting toxicity (DLT), will be defined based on toxicities seen within the first cycle. Among the additional 3 patients enrolled in a cohort, if one or more DLT is observed, the MTD will be considered to have been exceeded
Response rate of the combination of Velcade and Doxil in patients with metastatic breast cancer
时间窗: every 42 days
Radiographic response will be measured using RECIST criteria
次要结局
未报告次要终点