NCT00190671已完成1 期
A Phase 1/2 Dose-Escalating Study of ALIMTA and Cyclophosphamide Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Best Tumor Response
研究概览
简要总结
This is the phase 2 portion of a phase 1/2 trial, testing the use of pemetrexed and cyclophosphamide in combination for the treatment of advanced breast cancer. A single arm Phase 1 dose finding (establish maximum tolerated dose) study precedes the randomized phase 2 portion.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •You must be female and at least 18 years old. - You must have been diagnosed with breast cancer. - Your pre-study lab tests are within study requirements. - You must be willing to take folic acid and vitamin B12.
排除标准
- •You are pregnant or breastfeeding. - You have another illness that your doctor thinks would make you unable to participate. - You are currently taking aspirin or aspirin-like medicine and are unable to stop for a few days during each cycle of therapy.
研究组 & 干预措施
Pemetrexed 600 mg/m2
Experimental
干预措施: pemetrexed (Drug)
Pemetrexed 600 mg/m2
Experimental
干预措施: cyclophosphamide (Drug)
Pemetrexed 1800 mg/m2
Experimental
干预措施: cyclophosphamide (Drug)
Pemetrexed 1800 mg/m2
Experimental
干预措施: pemetrexed (Drug)
结局指标
主要结局
Best Tumor Response
时间窗: baseline to measured progressive disease
Tumor response was assessed using radiological imaging, which was repeated every 6 weeks prior to every other cycle. Confirmation of response was to occur no less than 4 weeks (28 days) after the first evidence of response.
次要结局
- Time to Progressive Disease(baseline to measured progressive disease)
- Progression Free Survival(baseline to measured progressive disease)
- Pharmacokinetics - Maximum Observed Drug Concentration (Cmax)(cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion))
- Pharmacokinetics - Area Under the Curve (AUC)(cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion))
- Pharmacokinetics - Clearance (CL)(cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion))
- Pharmacokinetics - Volume of Distribution(cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion))
- Pharmacokinetics - Half-Life (t½)(cycle 1 (Day 1: <1 min prior to end of pemetrexed infusion; 1/2, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours after start of pemetrexed infusion))
研究者
研究点 (1)
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