NCT00759824已完成2 期
A Phase II Study of Doxorubicin, Cyclophosphamide and Vindesine With Valproic Acid in Patients With Refractory or Relapsing Small Cell Lung Cancer After Platinum Derivatives and Etoposide
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
- 64
- 试验地点
- 5
- 主要终点
- Six-months progression-free survival
研究概览
简要总结
The primary aim of this study is to determine if the addition of valproic acid to a combination of adriamycin, cyclophosphamide and vindesine could increase progression-free survival in patients relapsing after first-line chemotherapy including platinum derivatives, cisplatin or carboplatin, and etoposide.
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 or cytological diagnosis of small-cell lung cancer (SCLC)
- •SCLC refractory to prior chemotherapy regimen including platinum derivatives (cisplatin or carboplatin) and etoposide, either primary refractory (immediate progression or recurrence less than 3 months after the end of previous chemotherapy) or secondary refractory (sensitive patients to platinum plus etoposide in first-line, progressing or recurring less than 3 months after reintroduction of the same chemotherapy).
- •At least one evaluable or measurable lesion
- •Availability for participating in the detailed follow-up of the protocol
- •Signed informed consent.
排除标准
- •Patient who were previously treated with anthracyclin or vinca-alcaloid derivatives or cyclophosphamide
- •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 or of the bladder or 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 (ejection 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 valproic acid and/or doxorubicin, cyclophosphamide, vindesine
- •Serious medical or psychological factors which may prevent adherence to the treatment schedule.
研究组 & 干预措施
1
Experimental
Chemotherapy regimen (adriamycin, cyclophosphamide, vindesine) plus valproic acid
干预措施: Adriamycin, cyclophosphamide, vindesine, valproic acid (Drug)
结局指标
主要结局
Six-months progression-free survival
时间窗: The period between the day of registration and the date of first progression
次要结局
- Survival(Survival will be dated from the date of registration)
- Response rate(Every three cycles of chemotherapy)
- Toxicity(After each course of chemotherapy and at the end of treatment)
研究者
研究点 (5)
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