NCT00107419已完成2 期
Phase II Trial of Pemetrexed for Advanced Chondrosarcomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 57
- 主要终点
- Response rate as measured by RECIST criteria
研究概览
简要总结
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent and unresectable or metastatic chondrosarcoma.
详细描述
OBJECTIVES:
Primary
- Determine the response rate (confirmed and unconfirmed complete response and partial response) in patients with recurrent and unresectable or metastatic chondrosarcoma treated with pemetrexed disodium.
Secondary
- Determine the toxicity of this drug in these patients.
- Correlate, preliminarily, response rates with deletions of methylthioadenosine phosphorylase (MTAP), as analyzed by fluorescence in-situ hybridization (FISH), in patients treated with this drug.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
pemetrexed
Experimental
pemetrexed
干预措施: pemetrexed disodium (Drug)
结局指标
主要结局
Response rate as measured by RECIST criteria
时间窗: every 9 weeks during treatment
x-rays or scans
次要结局
- Toxicity as measured by CTC v 3.0(every 3 weeks during treatment)
- Response rate compared with methylthioadenosine phosphorylase (MTAP) deletions as measured by fluorescence in-situ hybridization (FISH) retrospectively(end of study)
研究者
研究点 (57)
Loading locations...
相似试验
已完成
2 期
Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line ChemotherapyMalignant MesotheliomaNCT01085630Alliance for Clinical Trials in Oncology72
已完成
2 期
Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the UrotheliumUrethral CancerTransitional Cell Cancer of the Renal Pelvis and UreterBladder CancerNCT00053209Eastern Cooperative Oncology Group46
终止
2 期
Pemetrexed Disodium, Gemcitabine, and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung CancerLung CancerNCT00438204Barbara Ann Karmanos Cancer Institute39
已完成
2 期
Pemetrexed, Cisplatin, and Vitamin B12 in Treating Patients With Mesothelioma of the Chest That Cannot Be Removed by SurgeryMalignant MesotheliomaNCT00541073Centre Oscar Lambret60
已完成
2 期
Pemetrexed and Oxaliplatin in Treating Patients With Locally Advanced Head and Neck CancerHead and Neck CancerNCT00503997Vanderbilt-Ingram Cancer Center42