NCT00277069已完成1 期
INST: Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Measurable disease: Bidimensionally measurable lesions with clearly defined margins by 1) palpation with both diameters greater than 1 cm, 2) CT, MRI with both diameters greater than the distance between cuts of the imaging study.
研究概览
简要总结
- Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.
详细描述
- Determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.
- Determine a maximum tolerated dose of capecitabine in combination with vinorelbine and carboplatin for this patient population.
- Determine the time to relapse after the administration of this regimen.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient must have a histological diagnosis of breast cancer with metastasis.
- •The metastatic disease should be confirmed by biopsy if clinically indicated.
- •The patient must have measurable or evaluable disease.
- •Age > 18 years and < 75 years.
- •The patient may not have received prior therapy with vinorelbine, capecitabine, carboplatinum, or cisplatinum.
- •The patient may have received herceptin previously.
- •The patients must have previously received at least one cycle of chemotherapy.
- •The patient must have received anthracycline and taxane containing chemotherapy in the past. This may be either in the adjuvant setting or for metastatic disease. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse/progression within 6 months of completing chemotherapy.
- •Performance status <
- •At least 3 weeks must have elapsed since the completion of prior radiation therapy, chemotherapy, or hormonal therapy. The patient must have recovered from all grade 3-4 associated toxicities at the time of registration. Measurable or evaluable disease must be outside the previous radiation field or a new lesion must be present.
- •Patients must not receive concurrent hormonal, or biologic therapy, or radiation therapy to measurable or evaluable disease.
- •The patient should not have uncontrolled CNS disease.
- •Laboratory parameters: ANC > l500/ l, Platelets >100 000/ l, creatinine < 2.0, bilirubin < 2.0
- •Informed consent.
排除标准
- 未提供
结局指标
主要结局
Measurable disease: Bidimensionally measurable lesions with clearly defined margins by 1) palpation with both diameters greater than 1 cm, 2) CT, MRI with both diameters greater than the distance between cuts of the imaging study.
时间窗: disease progression or unacceptable toxicities
次要结局
未报告次要终点
研究者
研究点 (2)
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