NCT00634205已完成2 期
A Phase II Study Assessing the Activity of Valproate Acid Plus Doxorubicin in Refractory or Recurrent 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
- 45
- 试验地点
- 8
- 主要终点
- Response rate
研究概览
简要总结
The purpose of this study is to determine the response rate to the combination of doxorubicin and valproate acid in patients with MM failing after at least one previous chemotherapy regimen including platinum derivatives .
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
- •Histological diagnosis of malignant mesothelioma
- •Unresectable or inoperable malignant mesothelioma failing after at least one prior chemotherapy regimen including platinum derivatives (cisplatin or carboplatin)
- •At least one evaluable or measurable CT-lesion
- •Availability for participating in the detailed follow-up of the protocol
- •Signed informed consent
排除标准
- •Patients who are candidates for surgery with curative intent
- •Patient who were previously treated with anthracyclin derivatives
- •Performance status < 60 on the Karnofsky scale
- •A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
- •A history of prior HIV infection
- •Polynuclear cells < 2,000/mm³
- •Platelet cells < 100,000/mm³
- •Abnormal coagulation tests (aPTT, PTT, prothrombin time) and/or decreased fibrinogen
- •Serum bilirubin >1.5 mg/100 ml
- •Transaminases more than twice the normal range
- •Serum creatinine > 1.5 mg/100 ml
- •Recent myocardial infarction (less than 3 months prior to date of diagnosis)
- •Congestive cardiac failure (ejectional fraction of the left ventricle < 50%) or uncontrolled cardiac arrhythmia
- •Uncontrolled infectious disease
- •Active epilepsy needing a specific treatment
- •Concomitant treatment with IMAO, carbamazepine, mefloquine, phenobarbital, primidone, phenytoïn, lamotrigine, zidovudine
- •Pregnancy or refusal to use active contraception
- •A known allergy to valproate acid and/or doxorubicin
- •Serious medical or psychological factors which may prevent adherence to the treatment schedule
研究组 & 干预措施
A
Experimental
Continuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin
干预措施: Valproate plus doxorubicin (Drug)
结局指标
主要结局
Response rate
时间窗: Every 3 courses
次要结局
- Survival(Survival will be dated from the day of registration until death or last follow up)
- Toxicity(After each course of chemotherapy and at the end of treatment)
研究者
研究点 (8)
Loading locations...
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