NCT00065533已完成2 期
Study of Two Doses of ALIMTA (Pemetrexed) as First Line Chemotherapy for Advanced Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 19
- 主要终点
- To assess tumor response.
研究概览
简要总结
The purposes of this study are to determine the safety of pemetrexed and any side effects that might be associated with it, whether pemetrexed can help patients with breast cancer and how much pemetrexed should be given to patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Be at least 18 years of old.
- •Have been diagnosed with breast cancer
- •At least one year disease-free interval after initial treatment.
- •Have pre-study laboratory tests that are within the requirements of this study.
- •Be able to visit the doctor's office weekly during the treatment period.
排除标准
- •To be pregnant or breastfeeding.
- •To be currently taking aspirin or aspirin- like medicine and unable to stop for a few days during each cycle of therapy.
- •To have received prior chemotherapy for the treatment of metastatic cancer. Patients may have received prior hormonal treatment.
- •To have another illness that your doctor thinks would make you unable to participate.
- •To be unable or not willing to take folic acid and vitamin B12.
结局指标
主要结局
To assess tumor response.
次要结局
- To evaluate the toxicity profile of two doses of pemetrexed in breast cancer patients.
- To assess the following time-to-event efficacy variables: time to response, duration of response, duration of stable disease, time to documented progressive disease, time to treatment failure, progression-free survival, and overall survival.
- To identify the relationships, if any, that may exist between various molecular markers and pemetrexed efficacy and toxicity.
研究者
研究点 (19)
Loading locations...
相似试验
已完成
3 期
A Comparison of Two Doses of Pemetrexed in Patients Who Have Lung CancerNon-Small Cell Lung CancerNCT00078260Eli Lilly and Company589
已完成
2 期
A Study of Pemetrexed in Small Cell Lung Cancer, Which Has ReturnedCarcinoma, Small CellNCT00191750Eli Lilly and Company80
已完成
1 期
Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal CancerPrimary Peritoneal CancerOvarian CancerNCT00489359Eli Lilly and Company86
进行中（未招募）
不适用
Etude pharmacologique du Pemetrexed (Alimta) administré avec Cisplatine et supplémentation vitaminique chez des patients porteurs d'un mésothéliome pleural non résécable - ALIMESOmésothéliome pleuralMedDRA version: 9.1Level: LLTClassification code 10035605Term: Pleural mesothelioma malignant advancedMedDRA version: 9.1Level: LLTClassification code 10035606Term: Pleural mesothelioma malignant localisedMedDRA version: 9.1Level: LLTClassification code 10059518Term: Pleural mesothelioma malignantMedDRA version: 9.1Level: LLTClassification code 10035607Term: Pleural mesothelioma malignant recurrentEUCTR2006-004573-95-FRCentre Oscar Lambret
已完成
1 期
ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic CancerMetastasesCancerNCT00034463Eli Lilly and Company