Phase II Study of Alimta (Pemetrexed) Treatment of Advanced Thymoma and Thymic Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Objective Response Rate (Complete and Partial Response)
研究概览
简要总结
To study the efficacy of Alimta as a single agent in thymic cancers
详细描述
The broad range of clinical activity of thymic carcinomas makes the likelihood of detecting efficacy of a single agent such as premetrexed a reasonable objective since these malignancies are relatively slow growing and exhibit a broad range of chemosensitivity to antineoplastic agents.
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
- •Histologically confirmed invasive, recurrent or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery. Original biopsy of tumor is sufficient for diagnoses unless otherwise clinically indicated.
- •Patients must have measurable disease with at least one bidimensional measurable lesion. Any scans or x-rays used to document measurable disease must be obtained with 6 weeks prior to registration.
- •Patients may have had prior chemotherapy for metastatic disease
- •Adequate organ function as defined by: bili </=1.5; calc. crt clr of >/=45; hematologic-granulocytes >/=1500 & plt >/=100K.
- •Patients who are receiving a stable dose of corticosteroids for myasthenia gravis are eligible.
- •ECOG performance status of 0 or 1
排除标准
- •Acute intercurrent infection or complications
- •pregnancy or lactating patients
- •Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents.
- •Presence of clinically relevant third-space fluid collections that cannot be controlled by a procedure
研究组 & 干预措施
Pemetrexed
Pemetrexed infusion once every 21 days (one cycle).
干预措施: Premetrexed (Alimta) (Drug)
结局指标
主要结局
Objective Response Rate (Complete and Partial Response)
时间窗: Up to 3 years
The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. RECIST v1.0 will be used. At least a 30% decrease in the sum of the longest diameter of target lesions in reference to the baseline longest diameter will need to take place to be considered an objective response.
次要结局
- Duration of Remission(Time from the date of remission until progression or death, assessed up to 3 years)
- Grade 3/4 Treatment Related Adverse Events(Up to 3 years)
研究者
Patrick Joseph Loehrer Sr.
Professor of Medicine
Indiana University School of Medicine