NCT00295503已完成2 期
A Phase II Trial of Cisplatin, Pemetrexed and Bevacizumab in Untreated Malignant Mesothelioma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Progression Free Survival Rate at 6 Months
研究概览
简要总结
To estimate the time to progression of cancer in patients with previously untreated mesothelioma receiving cisplatin, pemetrexed and bevacizumab
详细描述
Secondary endpoints will include:
objective response rate
overall survival
In addition, the objective of the analysis of the correlative science data is to determine any association between tumor expression of VEGF/KDR complex and/or the presence of sv40 (as detected by PCR amplification) and objective response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- •a. General Medical Concerns 5.3.1 Patients must not be pregnant or breast feeding. 5.3.2 No "currently active" second malignancy other than non-melanoma skin cancer. Patients are not considered to have a "currently active" second malignancy if they have completed therapy and have a less than 30% risk of relapse.
- •5.3.3 No uncontrolled intercurrent illness including but not limited to: active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social situations that would limit compliance with study requirements.
- •5.3.4 No HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with study medications.
- •5.3.5 History of allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents used in the study.
- •5.3.6 Inability to interrupt aspirin or other non-steroidal medication for a 5 day period.
- •c. Bevacizumab-Specific Concerns
- •Subjects meeting any of the following criteria are ineligible for study entry:
- •5.3.7 Patients with brain metastases are excluded 5.3.8 History of myocardial infarction or CVA (stroke) within 6 months of study entry.
- •5.3.9 Evidence of bleeding diathesis or coagulopathy. Patients on therapeutic doses of coumadin are eligible as long as the INR is maintained in the range of 2-3 and there is no evidence of active bleeding.
- •5.3.10 Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study 5.3.11 Urine protein:creatinine ratio less than 1.0 at screening 5.3.12 Serious, non-healing wound, ulcer, or bone fracture
研究组 & 干预措施
1
Experimental
cisplatin, pemetrexed, and bevacizumab
干预措施: bevacizumab (Drug)
1
Experimental
cisplatin, pemetrexed, and bevacizumab
干预措施: cisplatin (Drug)
1
Experimental
cisplatin, pemetrexed, and bevacizumab
干预措施: pemetrexed (Drug)
结局指标
主要结局
Progression Free Survival Rate at 6 Months
时间窗: patients progression free at 6 months
This is the percentage of patients alive and progression-free at 6 months from initiation of treatment.
次要结局
- Overall Survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up 100 months)
- Response Rate(from time of enrollment to time of best response or death from any cause, whichever came first up to 100 months)
研究者
研究点 (1)
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