Phase I Dose Escalation Trial of Biweekly Alimta (With Vitamin Supplementation) in Combination With Taxotere in Advanced Solid Tumor Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Maximum-tolerated dose (MTD) of combination ALIMTA and Taxotere
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells of by stopping them from dividing. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of giving pemetrexed disodium and docetaxel together in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose of the combination of pemetrexed disodium and docetaxel when administered on a day 1 and day 15 dosing schedule.
Secondary
- To specifically characterize the toxicity profile for the combination of biweekly pemetrexed disodium and docetaxel.
- To investigate the antitumor activity in patients with advanced solid tumors as measured by RECIST criteria for patients with measurable disease or tumor markers for patients with non-measurable disease.
- To determine the recommended phase II dose of the combination of pemetrexed disodium and docetaxel on a biweekly dosing schedule.
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
Alimta and Taxotere
Alimta and Taxotere given in combination with dose modifications.
干预措施: Taxotere (Docetaxel) (Drug)
Alimta and Taxotere
Alimta and Taxotere given in combination with dose modifications.
干预措施: Alimta (Pemetrexed) (Drug)
结局指标
主要结局
Maximum-tolerated dose (MTD) of combination ALIMTA and Taxotere
时间窗: From first dose of the study drug until 30 days after the last administration of study medication
次要结局
- Toxicity(From first dose of the study drug until 30 days after the last administration of study medication)
- Antitumor activity(From first dose of the study drug until 30 days after the last administration of study medication)