A Multicenter Randomized Phase II Study of Docetaxel/Carboplatin Versus Docetaxel/Pegylated Liposomal Doxorubicin as Second Line Treatment in Patients With Platinum Sensitive Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 34
- 试验地点
- 12
- 主要终点
- Overall Response Rate
研究概览
简要总结
This trial will compare the efficacy of docetaxel/carboplatin versus docetaxel/liposomal doxorubicin in pretreated patients with advanced ovarian carcinoma and treatment free-interval of at least six months
详细描述
The second-line treatment in advanced ovarian cancer has been proved effective in prolonging overall survival and improving quality of life. In patients with platinum-sensitive ovarian cancer (relapsed disease after 6 months from the end of first line chemotherapy) the combination of paclitaxel/carboplatin is considered the standard treatment. Generally, the combination platinum-based chemotherapy may well be associated with a survival benefit in patients with platinum-sensitive disease. Carboplatin, pegylated doxorubicin (caelyx) docetaxel, have been approved for second-line treatment of ovarian carcinoma and seem to be active in platinum-sensitive disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed ovarian cancer
- •Stage IIIB/IV
- •Failure to prior chemotherapy with paclitaxel /carboplatin regimen and treatment free interval > 6 months
- •Presence of two-dimensional measurable disease.
- •Life expectancy of more than 3 months.
- •Age ≥ 18 years.
- •Performance status (WHO) 0-2
- •Adequate bone marrow function (Absolute neutrophil count >1000/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3)
- •Adequate liver (Bilirubin<1.5 times upper limit of normal and SGOT/SGPT<2 times upper limit of normal) and renal function (creatinine<2mg/dl)
- •Informed consent
排除标准
- •Pregnant or nursing
- •Psychiatric illness or social situation that would preclude study compliance'
- •Other concurrent uncontrolled illness
- •Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •Other concurrent investigational agents
研究组 & 干预措施
1
Docetaxel/carboplatin
干预措施: Docetaxel (Drug)
1
Docetaxel/carboplatin
干预措施: Carboplatin (Drug)
2
Docetaxel/Caelyx
干预措施: Docetaxel (Drug)
2
Docetaxel/Caelyx
干预措施: Liposomal doxorubicin (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
次要结局
- Overall Survival(1 year)
- Toxicity profile(Toxicity assessment on each cycle)
- Time to tumor progression(1 year)