Phase II Trial of Alimta (Pemetrexed) and Gemzar (Gemcitabine) in Metastatic Breast Cancer Patients Who Have Received Prior Taxane Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Overall Tumor Response
研究概览
简要总结
The purpose of the study is to determine if the two drugs can help patients feel better while causing the tumor to become smaller or disappear; evaluate the safety of giving both pemetrexed and gemcitabine in patients with advanced breast 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
- 否
入选标准
- •Must have received prior chemotherapy with Taxol (paclitaxel) or Taxotere (docetaxel).
- •Less than 3 different chemotherapy treatments for metastatic disease.
- •Prior treatment with hormonal and/or radiation therapy.
- •Must have disease that can be measured.
- •Must be able to take care of self needs for example personal hygiene
排除标准
- •Must not be pregnant or breast-feeding.
- •Cancer that has spread to the brain.
- •Treatment with Gemcitabine or Pemetrexed
- •Unable to take folic acid or Vitamin B12
- •Treatment for another cancer within the last 5 years
研究组 & 干预措施
A
干预措施: Pemetrexed (Drug)
A
干预措施: Gemcitabine (Drug)
B
干预措施: Gemcitabine (Drug)
B
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Overall Tumor Response
时间窗: Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated
Best overall (confirmed) response recorded from start of treatment until disease progression/recurrence, start of other anti-tumor therapy/intervention, or end of trial, whichever comes first. Response must be confirmed at least 6 weeks from previous scans. Best overall response assignment depends on both measurement and confirmation criteria.
次要结局
- Duration of (Confirmed) Complete Response or Partial Response(Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated)
- Time to Progressive Disease(Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated)
- Time to Treatment Failure(Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated)
- Overall Survival(Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated)