NCT01333696Unknown2 期
Phase II Study of Pemetrexed Monotherapy in Patients With Platinum-resistant Squamous Cell Carcinoma of Head and Neck
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
The aim of the study is to evaluate the efficacy and safety of pemetrexed monotherapy as salvage treatment in patients with relapsed or metastatic squamous cell carcinoma of head and neck.
详细描述
The treatment option in patients with platinum-resistant relapsed or metastatic squamous cell carcinoma of head and neck is limited. Previous randomized phase III study showed a borderline benefit of pemetrexed added to cisplatin. Therefore, we aim to evaluate the efficacy of pemetrexed in salvage setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18-65 years old
- •Histological confirmed incurable relapsed or metastatic squamous cell carcinoma of head and neck
- •Prior exposure of at least one line of platinum-containing regimen
- •At least one site of measurable disease according to RECIST criteria
- •ECOG performance status 0-1
- •Life expectancy of more than 3 months
- •Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
- •Liver function: total bilirubin, ALT and AST <1.5×UNL
- •Renal function: Cr<1.5×UNL, CCR≧45ml/min
排除标准
- •With curable treatment option
- •Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Significant active infection
- •Pregnant or lactating women
研究组 & 干预措施
Pemetrexed
Experimental
500 mg/m2, repeated every 3 weeks until disease progression or intolerable toxicity
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Overall response rate
时间窗: 6 weeks
次要结局
- Median progression-free survival(1 year)
- Median overall survival(1 year)
研究者
研究点 (1)
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