Open Multicenter Phase II Study in Second-Line Metastatic Colorectal Cancer Patients: Combination of ALIMTA and Irinotecan Administered Every Two-Weeks
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Best Overall Tumor Response
研究概览
简要总结
A non-randomized phase II study to determine the efficacy and safety of the combination of Pemetrexed and Irinotecan every two weeks in metastatic colorectal cancer patients.
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
- •Diagnosis of metastatic colorectal adenocarcinoma that is not amenable to curative therapy.
- •Patient must have at least one unidimensionally measurable lesion.
- •Prior radiation therapy to less than 25% of bone marrow. Radiation must be completed at least 4 weeks prior to study enrollment.
- •Performance status 0 to 2
- •Patient must have received 1 prior course of chemotherapy (Folfox regimen) for metastatic disease
排除标准
- •Treatment with any drug within the last 30 days that has not received regulatory approval.
- •Serious systemic disorder (cardiac or pulmonary disease, active infection)
- •Documented brain metastases not amenable to surgery or unstable after radiation
- •Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
- •Presence of fluid retention that can not be controlled by drainage.
研究组 & 干预措施
Pemetrexed + Irinotecan
干预措施: pemetrexed (Drug)
Pemetrexed + Irinotecan
干预措施: irinotecan (Drug)
结局指标
主要结局
Best Overall Tumor Response
时间窗: baseline to measured progressive disease (up to 2 years follow-up)
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria.
次要结局
- Duration of Response(time of response to progressive disease or death (up to 2 years follow-up))
- Progression-Free Survival (PFS)(baseline to measured progressive disease or death (up to 2 years follow-up))
- Time to Treatment Failure(baseline to stopping treatment (up to 2 years follow-up))
- Overall Survival(baseline to date of death from any cause (up to 2 years follow-up))