NCT00490373已完成2 期
A Phase 2 Trial of ALIMTA in Pretreated Patients With Unresectable or Metastatic Cancer of the Pancreas
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy.
研究概览
简要总结
This study with pemetrexed is for patients with metastatic or unresectable pancreatic cancer who progressed after first line chemotherapy with gemcitabine.
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
- •Histological or cytological diagnosis of adenocarcinoma of the pancreas that is locally advanced (Stage II, III) or metastatic (Stage IV), as staged by the American Joint Committee on Cancer (AJCC; Protocol Attachment S041.2; Fleming et al. 1997), and not amenable to resection with curative intent.
- •Prior systemic first line chemotherapy with gemcitabine single agent or a combination regimen including gemcitabine (not more than one prior systemic chemotherapy allowed).
- •Uni-dimensionally measurable disease according to the RECIST criteria (Therasse et al. 2000), defined as: At least one lesion that can be accurately measured in at least one dimension, with the longest diameter greater than or equal to 2 cm with conventional techniques or greater than or equal to 1.0 cm with spiral CT scans. Ultrasound and X-ray are NOT allowed to measure or follow lesions.
排除标准
- •Prior radiation of equal to or greater than 25% of the bone marrow (Cristy and Eckerman 1987)
- •Prior immunotherapy, biological therapy, and/or hormonal therapy for pancreas cancer.
- •Prior systemic chemotherapy with 5-FU.
- •Patient not yet recovered from the acute toxic effects of the treatment prior to study enrollment.
- •Radiotherapy within the last 4 weeks before study entry
结局指标
主要结局
To evaluate the efficacy.
次要结局
- To assess tumor response.
- To assess time to event efficacy variables including time to progressive disease and overall survival.
- To characterize the quantitative and qualitative toxicities of pemetrexed in this population of pancreatic cancer patients.
研究者
研究点 (1)
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