Phase II Study With Capecitabine as Monotherapy in the Treatment of Platinum Resistant or Refractory Ovarian Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 17
- 主要终点
- objective response rate
研究概览
简要总结
The purpose of this study is to evaluate the activity and the toxicity of capecitabine as monotherapy in the treatment of platinum resistant or refractory ovarian cancer.
详细描述
Ovarian cancer is the second most frequent and the most deadly gynaecologic cancer. Standard combination chemotherapy with a platinum derivative (cisplatin or carboplatin) and a taxane are effective in causing remission in 60 - 80 % of cases, yet recurrences are frequent and 5-year survival is only 20%. Current therapies for second line treatment of recurrence in patients who have platinum refractory (who experienced progression of the disease during first line platinum based therapy) or platinum resistant (who experienced a recurrence of the disease within 6 months of completing platinum based therapy)ovarian cancer are limited. Capecitabine, an oral chemotherapy already used in colon and breast cancers, has shown some promise in early clinical trials for treating recurrent ovarian cancer.
Patients entered into this trial will receive oral capecitabine 1250 mg/m2 on days 1-14 every 21 days for up to 6 cycles, depending on response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cytologic or histologic diagnosis of relapsed ovarian cancer
- •Refractory or resistant to platinum salts disease
- •Age < 75 years
- •At least one measurable lesion (³ 20 mm with conventional techniques or ³ 10 mm with spiral CT scan)
- •Life expectancy of at least 3 months
- •Written informed consent
排除标准
- •Previous or concomitant malignant neoplasia within 5 years prior to basal evaluation (excluding adequately treated basocellular or spinocellular skin carcinoma or in situ carcinoma of the uterine cervix).
- •Performance Status (ECOG) ³ 3
- •Previous chemotherapy treatment with capecitabine
- •More than 3 lines of chemotherapy
- •Heart disease (heart failure, heart attack during the 6 months prior to the trial, atrioventricular block of any degree, serious arrhythmia)
- •Leukocytes < 4000/mm3, platelets < 100000/mm3
- •Modifications of renal function (Creatinine ³ 1.25 times the upper normal limit) or liver function (SGOT or SGPT ³ 1.25 times the upper normal limit)
- •Present or suspected haemorrhagic syndromes
- •Uncooperative and/or unreliable patients
- •Patients' inability to access the centre
研究组 & 干预措施
Capecitabine
干预措施: capecitabine (Drug)
结局指标
主要结局
objective response rate
时间窗: 6 months
toxicity
时间窗: up to 6 months
次要结局
未报告次要终点