Multicenter and Prospective Phase II Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 主要终点
- Progression free survival (PFS) rate
研究概览
简要总结
Multicenter and prospective phase II trial with gemcitabine and rapamycin in second line of metastatic osteosarcoma. The study includes 6 cycles of the combination gemcitabine+rapamycin in metastatic or unresectable osteosarcoma patients.
详细描述
The trial seeks to analyze progression free survival (PFS), measured as PFS rate at 4 months, in patients with metastatic osteosarcoma who have previously received the most active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide). The treatment schedule consists of a maximum of 6 cycles of 3 weeks of gemcitabine+rapamycin. Gemcitabine is given at 800 mg/m2 in days 1 and 8 in cycles of 21 days. Rapamycin is given at 5 mg per day during treatment duration.
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
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed before any trial test
- •Age equal or less than 80 years
- •Histological diagnosis of high-grade, metastatic or unresectable osteosarcoma in progression
- •Previous treatment with drugs used in first line: methotrexate, adriamycin, platinum
- •Measurable disease, acoording to RECIST criteria
排除标准
- •Patients who have been irradiated on target lesions
- •Bilirubin levels over normal values. Creatinine over 1.6 mg/dL
- •History of other cancers except basal cell cancer or cervical cancer adequately treated
- •Serious cardiovascular disease
研究组 & 干预措施
Experimental
6 cycles of gemcitabine plus rapamycin
干预措施: Gemcitabine plus rapamycin (Drug)
结局指标
主要结局
Progression free survival (PFS) rate
时间窗: 4 months
次要结局
- Tumor response according to RECIST(6 months)