Phase II Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- progression free rate
研究概览
简要总结
The yearly incidence of soft-tissue sarcomas(STS) in the USA is roughly 11,280 cases, and metastatic STS have a median overall survival of about 12 months. After the standard 1st line chemotherapy with doxorubicin, the only a few treatment option is available. Recently, pemetrexed, a novel multitargeted antifolate, has shown modest activity as a single agent lung cancer and mesothelioma. In patients with refractory STS, pemetrexed is well tolerated and moderately effective. Based on the background, investigators planned to conduct the phase II trial of pemetrexed in combination with cisplatin for metastatic/recurred soft-tissue sarcomas.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced bone and soft tissue sarcoma with prior chemotherapy including anthracycline or ifosfamide
- •Measurable or evaluable disease (RECIST 1.1.)
- •Age ≥19 years
- •ECOG performance status of 0-2
- •Adequate laboratory findings
- •Absolute neutrophil count (ANC) ≥ 1500 /µL
- •Platelet count ≥ 75,000/ µL
- •Serum creatinine < 1.5 x upper limit of normal (ULN)
- •AST (SGOT) and ALT (SGPT) < 3 x upper limit of normal (ULN)
- •Total bilirubin <1.5 x upper limit of normal (ULN)
- •more than 3 months of expected survival
- •Provision of written informed consent prior to any study procedure
排除标准
- •Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study'
- •Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
- •Resectable lung metastases
- •Uncontrolled or active CNS metastasis and/or carcinomatous meningitis
- •Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma, thyroid cancer or cervical cancer in situ.
- •Uncontrolled medical conditions
研究组 & 干预措施
pemetrexed+cisplatin
Patients with metastatic sarcoma who underwent one chemotherapy regimens are treated with the combination of pemetrexed and cisplatin, and the treatment is repeated until the disease progression. pemetrexed 500 mg / m2 (day 1) and cisplatin 75 mg / m2 (day 1) are intravenously injected. 21 days is one cycle, and it is carried out by co-administration up to 6 cycles. After 7 cycles, intravenous injection of pemetrexed alone at intervals of 3 weeks until disease progression.
干预措施: Pemetrexed, cisplatin (Drug)
结局指标
主要结局
progression free rate
时间窗: 12 weeks
次要结局
- adverse event(every 3 weeks)