NCT01192633Unknown2 期
Phase Ⅱ Study of Gemcitabine,Vincristine and Cisplatin as Second Line Combination Therapy in Patients With Sarcoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progression-free Survival(Progression-free survival was evaluated for the period from the date of first treatment with this regimen to the date when disease progression was first observed or death occurred.)
研究概览
简要总结
The primary objective of this study is to evaluate PFS of gemcitabine,vincristine and cisplatin as second line therapy in patients with sarcoma. 40 patients will be treated into this study.
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
- Prevention
- 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
- •Give written informed consent prior to study, with understanding that the patient has the right to withdraw from the study at any time without prejudice
- •Be female of male and ≥18 and ≤75 years of age
- •Be ambulatory and have ECOG performance status of ≤1
- •Have histological confirmed sarcoma
- •Locally advanced or metastatic sarcoma who receive first-line chemotherapy.
- •Have at least one target lesion according to the RECIST criteria.
排除标准
- •Pregnant or lactating women
- •patient has received chemotherapy drugs including gemcitabine,vincristine and cisplatin
- •Chemotherapy within four weeks preceding treatment start
- •Radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start or insufficient recovery from the effects of prior radiotherapy
- •Participation in any investigational drug study within 4 weeks preceding treatment start
- •History of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix .Abnormal laboratory values: hemoglobin <
- •0g/dl, neutrophil< 1.5×109/L, platelet< 100×109/L.
- •serum creatine > upper limit of normal (ULN)
- •serum bilirubin > ULN
- •alanine aminotransferase(ALT) and aspartate aminotransferase(AST)>5×ULN
- •alkaline phosphatase(AKP)>5×ULN
- •Serious uncontrolled intercurrence infection
- •Life expectancy of less than 3 months
结局指标
主要结局
Progression-free Survival(Progression-free survival was evaluated for the period from the date of first treatment with this regimen to the date when disease progression was first observed or death occurred.)
时间窗: every 6 weeks
次要结局
- Response Rate(every 6 weeks)
- Overall Survival(2 years)
- Side Effects(every 3 weeks)
研究者
研究点 (1)
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