Open-Label Single-Arm Phase IV Study of Pemetrexed in Taiwanese Patients With Advanced Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR])
研究概览
简要总结
The purpose of this study is to assess the efficacy and toxicity of pemetrexed dosing that is tailored to individual patient tolerance in patients with advanced non-small cell lung cancer (NSCLC).
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
- •Histologic or cytologic diagnosis non-small cell lung cancer (NSCLC) (Stage IIIB or IV)
- •Patients' NSCLC must have progressed following one chemotherapy regimen for palliative therapy with or without subsequent targeted biological therapy
- •Disease status must be that of measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
排除标准
- •Concurrent administration of any other tumor therapy
- •Pregnancy or breast feeding
- •Serious concomitant disorders
- •Inability or unwillingness to take folic acid or vitamin B12 supplementation
研究组 & 干预措施
Pemetrexed
干预措施: pemetrexed (Drug)
结局指标
主要结局
Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR])
时间窗: baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment)
The objective response rate (ORR) was defined as the proportion of participants who achieved a best response of either complete response (CR) or partial response (PR) (responders) based on the RECIST criteria. ORR=(CR+PR)/Number of Participants. The RECIST define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments.
次要结局
- Proportion of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate [DCR])(baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment))
- Overall Survival(baseline to date of death from any cause (includes post-treatment follow-up of up to 18 months post-Last Patient Entered Treatment))
- Progression-Free Survival (PFS)(baseline to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment))
- Duration of Response(time of response to measured progressive disease or death from any cause (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment))
- Time to Treatment Failure(baseline to early treatment discontinuation or measured progressive disease or death from any cause (assessments every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment))
- Time to Tumor Progression(baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until documented disease progression, or up to 18 months after enrollment))