A Phase I Study Of Vinorelbine Oral Plus Capecitabine Combination In Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Maximum Tolerated Dose (MTD) of vinorelbine oral plus capecitabine combination
研究概览
简要总结
This study will evaluate the toxicity and secondary the efficacy of the combination vinorelbine plus capecitabine in metastatic breast cancer patients
详细描述
The combination capecitabine-vinorelbine, with iv administration of vinorelbine, has been studied in a phase [I]/[II], with favourable profile of toxicity in pretreated patients with anthracyclines and/or taxanes (Oncology News International vol 12, no 3, suppl 2, 2003).
In a study of toxicity and effectiveness, Vanhopher reported objective response rates (PR) in 21 from 45 patients (47%) and stabilization of disease (SD) in 16 patients (36%). Severe leucopenia (grade 4), was reported in 5% of patients (Borquez D, et al: Proc Am Soc Clin Oncol 19: Abstract 420, 2000)
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 confirmed metastatic breast cancer
- •Age 18-75 years
- •Bidimensionally measurable or evaluable disease
- •Performance status (PS) 0-2 (ECOG)
- •Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during treatment and for three months after completing treatment
- •Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the UNL in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the upper normal limit); and adequate bone marrow function(neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)
- •At least three weeks from completion of irradiation
- •Life expectancy ≥ 12 weeks
- •Patients able to take oral medication
- •written informed consent
排除标准
- •Active infection
- •Brain metastases
- •History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- •Malnutrition (loss of ≥ 20% of the original body weight)
- •Psychiatric illness or social situation that would preclude study compliance
- •Pregnant or lactating women
研究组 & 干预措施
1
Vinorelbine oral plus Capecitabine
干预措施: Vinorelbine oral (Drug)
1
Vinorelbine oral plus Capecitabine
干预措施: Capecitabine (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of vinorelbine oral plus capecitabine combination
时间窗: Toxicity assessment at 1st cycle
Dose Limited Toxicity (DLT) of vinorelbine oral plus capecitabine combination.
时间窗: Toxicity assessment at 1st cycle
次要结局
- Response Rate(Response evaluation at 3rd and 6th cycle by CT's or MRI)