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临床试验/NCT00191412
NCT00191412已完成2 期

Phase II Study of Single-Agent Alimta in the Treatment of Patients With Advanced and Metastatic Hepatoma

Eli Lilly and Company1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2005年1月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
41
试验地点
1
主要终点
Antitumor activity as measured by Response Evaluation Criteria in Solid Tumors

研究概览

简要总结

This study is to assess the response rate, toxicity, time-to-event efficacy, and potential markers of pemetrexed in patients with liver cancer.

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

入选标准

  • Diagnosis of cancer of the liver which is metastatic or locally recurrent and not amendable to curative therapy.
  • Patient must have measurable disease
  • Patient may have received prior arterial chemoembolization, completed 8 weeks prior to study enrollment, but no other previous chemotherapy
  • Prior radiation is permitted, but must be completed at least 2 weeks prior to study enrollment.
  • Prior central nervous system metastases are acceptable if the patient has received radiation ot the brain, is not on steroids, and does not have related symptoms.

排除标准

  • Patients who have had prior therapy with Pemetrexed.
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
  • Patients who have received radiation to more than 25% of marrow

结局指标

主要结局

Antitumor activity as measured by Response Evaluation Criteria in Solid Tumors

次要结局

  • Toxicity measured by CTCAE grading
  • Duration of response: First complete or partial response until progressive disease (PD) or death of any cause
  • Duration of stable disease: Enrollment to PD or death of any cause
  • Time to treatment failure: Enroll. to PD, death of any cause, early discontinuation of treatment for any reason other than adequate response or start of new therapy
  • Progression-free survival: Enroll. to PD or death of any cause
  • Overall survival: Enroll. to death of any cause

研究者

申办方类型
Industry

研究点 (1)

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