Phase II Trial of Pemetrexed in Second Line Advanced/Metastatic Osteosarcomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Tumor Response
研究概览
简要总结
The primary purpose of your participation in this study is to help answer the following research questions, and not to provide you treatment for your condition.
- To assess how well treatment with pemetrexed works for patients with your type of cancer
- To assess for any side effects that might be associated with pemetrexed.
- To look at the characteristics and levels of certain of your genes and proteins to learn more about osteosarcoma and how pemetrexed works in your body.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of high grade locally advanced or metastatic osteosarcoma
- •Must have one prior chemotherapy regimen for advanced disease
- •At least 1 unidimensional measurable lesion by computed tomography (CT) scan
- •Have a good performance status
- •Adequate organ function
排除标准
- •Have a serious concomitant systemic disorder (for example active Human Immunodeficiency Virus infection)
- •Have brain metastases not adequately treated
- •Significant weight loss (that is more than 20%) over the previous 6 weeks before study entry
- •Inability or unwillingness to take folic acid or vitamin B12 supplementation and corticosteroids
- •Pregnant or breast-feeding
研究组 & 干预措施
Pemetrexed
Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle.
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Percentage of Participants With Tumor Response
时间窗: Baseline to 21 months
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) = at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria. Tumor Response Rate(%) = sum of number of PR + CR observed/number of participants qualified for tumor response analysis \* 100.
次要结局
- Time to Treatment Failure(Baseline to 21 months)
- Correlation of Disease Outcome With Pharmacogenomic Analysis(Baseline to 21 months)
- Number of Participants With Adverse Events (Pharmacology Toxicity)(Baseline to 21 months)
- Duration of Response(Baseline to 31 months)
- Progression-Free Survival (PFS)(Baseline to 10.4 months)
- Overall Survival (OS) Time(Baseline to 27.6 months)