A Phase II Study of Efficacy and Safety of Paclitaxel and Cisplatin Every 2 Weeks as the First-line Treatment of Patients With Ovarian Cancer Stage Ic-IV.
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving paclitaxel together with cisplatin as first-line therapy and to see how well it works in treating patients with stage I, stage II, stage III, or stage IV ovarian epithelial cancer.
详细描述
OBJECTIVES:
- To investigate the efficacy and safety of paclitaxel and cisplatin as first-line chemotherapy in patients with stage IC-IV ovarian epithelial cancer.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV and cisplatin IV once every 2 weeks. Treatment repeats every 2 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed epithelial adenocarcinoma of the ovary
- •Stage IC-IV disease
- •No known or clinical evidence of brain metastasis
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Hemoglobin must be ≥ 90 g/L
- •ANC ≥ 2 x 10^9/L
- •Platelet count ≥ 100 x10^9/L
- •Serum creatinine ≤ 115 μmol/L
- •Total bilirubin ≤ 25 μmol/L
- •Not pregnant or nursing
- •No other serious disease which could affect protocol compliance and results
- •No other prior malignancy within the past 5 years except for curatively treated carcinoma in situ of the cervix or squamous carcinoma of the skin
- •No peripheral neuropathy ≥ CTCAE version 3.0 grade 2
- •No known hypersensitivity to any of the study drugs or their excipients
- •No drug addiction or alcoholism
- •No disorder which leads to the condition that contraindicates the use of the investigational drugs, or that may affect the patient's compliance with the study requirements
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy or radiotherapy for ovarian cancer
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
次要结局
- Overall survival
- Objective response rate (complete and partial remission in patients with measurable disease)
- Toxicity