Dose Dense Administration of Paclitaxel and Carboplatin Combination as 1st Line Treatment in Patients With Ovarian Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 12
- 主要终点
- Determine the maximum tolerated dose and the response rate
研究概览
简要总结
This trial will determine the feasibility and toxicity of dose intense (every 2 weeks) of paclitaxel+carboplatin combination following cytoreductive surgery in patients with stage Ic-IV ovarian cancer.
详细描述
Dose dense chemotherapy has been proven beneficial in various oncological settings. It is proposed that this concept be tested in ovarian cancer, with the support of growth factors. It is hypothesized that, if feasible, dose-dense chemotherapy may be more effective.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically- or cytologically- confirmed ovarian cancer requiring standard chemotherapy
- •Patients have to be chemotherapy naive
- •Patients may have undergone cytoreductive surgery, or this may have been omitted due to dissemination
- •Age >18 years.
- •Performance status (WHO) 0-2
- •Life expectancy of at least three months.
- •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
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
研究组 & 干预措施
1
Paclitaxel/Carboplatin
干预措施: Paclitaxel (Drug)
1
Paclitaxel/Carboplatin
干预措施: Carboplatin (Drug)
结局指标
主要结局
Determine the maximum tolerated dose and the response rate
时间窗: Toxicity assestment of the 1st cycle for the first 10 patients. Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
次要结局
- Time to tumor progression(1 year)
- Toxicity profile(Toxicity assessment on each cycle)