Phase I/II Trial of Abraxane® (ABI-007) and Alimta® (Pemetrexed) in Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Number of Participants With Dose Limiting Toxicities
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. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel albumin-stabilized nanoparticle formulation together with pemetrexed may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with pemetrexed and to see how well they work in treating patients with advanced non-small cell lung cancer, breast cancer, or other solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the safety of paclitaxel albumin-stabilized nanoparticle formulation when administered with pemetrexed disodium in patients with advanced non-small cell lung cancer, breast cancer, or other solid tumors. (Phase I)
- Determine the efficacy of this regimen, as measured by objective tumor response rate (RECIST criteria), in these patients. (Phase II)
Secondary
- Determine the preliminary efficacy of paclitaxel albumin-stabilized nanoparticle formulation and pemetrexed disodium in these patients. (Phase I)
- Determine the overall survival of patients treated with this regimen. (Phase II)
- Evaluate the frequency and severity of toxicities associated with this regimen. (Phase II)
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
Phase I: Abraxane and Alimta
Three dose levels were tested. Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 180, 220, and 260 mg/m2 every 21 days.
干预措施: Abraxane (Drug)
Phase I: Abraxane and Alimta
Three dose levels were tested. Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 180, 220, and 260 mg/m2 every 21 days.
干预措施: Alimta (Drug)
Phase II: Abraxane and Alimta
Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 260 mg/m2 every 21 days.
干预措施: Abraxane (Drug)
Phase II: Abraxane and Alimta
Pemetrexed 500mg/m2 day 1 and nab-paclitaxel day 1 at 260 mg/m2 every 21 days.
干预措施: Alimta (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities
时间窗: Up to21 days
Dose limiting toxicity (DLT) was defined as any of the following occurring during the first cycle: Grade 4 thrombocytopenia, or grade 3 thrombocytopenia associated with bleeding, requirement for transfusion, febrile neutropenia, neutropenia with documented infection. Non-hematologic DLT included any other ≥ grade 3 non-hematologic toxicity that was clinically significant and considered by the investigator to be related to study drug. Alopecia and grade 3 allergic reaction/hypersensitivity with infusion were not considered DLTs.
Number of Patients With Toxicities
时间窗: Up to 1 year
Toxicities was evaluated based on the standard NCI CTCAE Version 3.0 grading criteria. Attributable grade ≥ 3 hematologic and non-hematologic toxicities are presented here.
次要结局
- Duration of Overall Survival(Up to 2 years)
- Number of Participants With Complete Response(Up to 2 years)
- Number of Participants With Stable Disease(Up to 2 years)
- Number of Participants With Partial Response(Up to 2 years)
- Number of Participants With Disease Control(Up to 2 years)