Phase 1/2 Study of Pemetrexed Plus Cisplatin in Unresectable, Advanced Gastric Carcinoma.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Objective Best Tumor Response
研究概览
简要总结
This is a multicenter, single arm, open-label Phase 1/2 study of pemetrexed plus cisplatin for patients with unresectable, advanced gastric cancer who had no prior palliative chemotherapy. Phase 1 was designed to determine the optimal dose of pemetrexed for its phase 2, which has been completed and now a total of 60 qualified patients will be enrolled in the phase 2 of this study. The treating physician will determined the maximum number of cycles of pemetrexed plus cisplatin that a patient may receive in this study.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological proven diagnosis of adenocarcinoma of the stomach
- •Stage IV disease not amenable to curative surgery.
- •Disease status must be that of measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- •Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale.
- •Adequate organ functions
排除标准
- •Prior palliative chemotherapy for advanced gastric cancer.
- •Pregnancy and breast feeding.
- •Known or suspected brain metastasis and secondary primary malignancy
- •Inability to interrupt aspirin, or other non-steroidal anti-inflammatory agents for a 5-day period.
- •Inability or unwillingness to take folic acid or vitamin B12 supplementation.
- •Concurrent administration of any other tumor therapy.
研究组 & 干预措施
A
干预措施: pemetrexed (Drug)
A
干预措施: cisplatin (Drug)
结局指标
主要结局
Objective Best Tumor Response
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 disease progression, or up to 12 months after enrollment)
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
次要结局
- Duration of Response(time of response to progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment))
- Progression Free Survival(baseline to measured progressive disease or death (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment))
- Overall Survival(baseline to date of death from any cause (Survival follow-up were performed every 2 cycles during therapy and approximately every 3 months during post-therapy until death or up to 12 months after enrollment))