Metronomic Vinorelbine in Patients With Metastatic Tumors: Phase II Translational Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 11
- 主要终点
- time to treatment failure
研究概览
简要总结
Patients with recurrent or metastatic solid tumors receive oral vinorelbine at one of three different doses (30 or 40 or 50 mg). Vinorelbine will be administered orally at a metronomic schedule three times a week: on Monday, Wednesday and Friday.
详细描述
The purpose of this study is to define the biologically optimal dose of vinorelbine when administered at a metronomic dosing schema. [Metronomic chemotherapy refers to the close, regular administration of minimally toxic doses of cytotoxic drugs, with minimal or no drug-free breaks, over prolonged periods]. Patients with recurrent or metastatic solid tumors are randomly assigned one of three different doses of oral vinorelbine (30 or 40 or 50 mg). Treatment is administered three times a week (Monday, Wednesday and Friday) continuously until disease progression or unacceptable toxicity or to a maximum of 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Ages 16 - 75 years
- •Genders: both
- •Performance status 0-2 according to the World Health Organization (WHO) scale
- •Life expectancy of at least 16 weeks
- •Adequate bone marrow, hepatic and renal functions
- •Absence of brain metastasis
- •Metastatic/locally advanced refractory prostate, breast or non-small cell lung cancer previously treated with no more than two chemotherapeutic regimens
- •White blood cells >= 3500/mm^3
- •Absolute neutrophil count >= 1500/mm^3
- •Platelets >= 100,000/mm^3
- •Total serum bilirubin less than 1.5 mg/dl
- •Serum transaminases less than 2.0 x upper normal limit (UNL) unless attributed to liver metastases
- •Serum creatinine within normal range
排除标准
- •Major active infection
- •More than two prior chemotherapy regimens for metastatic disease
- •Any of the following within the 12 months prior to starting the study treatment:
- •myocardial infarction,
- •severe/unstable angina,
- •coronary/peripheral artery bypass graft,
- •congestive heart failure,
- •cerebrovascular accident or transient ischemic attack, or pulmonary embolism,
- •cardiac dysrhythmias of grade >/= 2,
- •atrial fibrillation of any grade, or
- •heart rate corrected interval (QTc) > 450 msec for males or > 470 msec for females.
- •Hypertension that cannot be controlled with medications (> 150/100 mmHg despite optimal medical therapy)
- •Ongoing anti-coagulation therapy
- •Pregnancy or breastfeeding
- •Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration; or which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial.
研究组 & 干预措施
1
干预措施: vinorelbine oral formulation (Drug)
2
干预措施: vinorelbine oral formulation (Drug)
3
干预措施: vinorelbine oral formulation (Drug)
结局指标
主要结局
time to treatment failure
时间窗: TTF rates per arm will be compared at 4 and 6 months
次要结局
- progression free survival(Patients will be assessed every 2 months during the first 6 months on treatment and every 4 months thereafter until documentation of objective tumor progression or death.)
- time to progression(Patients will be assessed every 2 months during the first 6 months on treatment and every 4 months thereafter until documentation of objective tumor progression.)
- toxicity(Acute toxicity will be assessed during the first 8 weeks, sub-acute 8 weeks to 4 months, chronic post 4 months)
- changes in blood concentrations of angiogenesis-associated surrogate markers and pharmacokinetics(Baseline values will be assessed for predictive potential and assessment on weeks 2,4,8, 12 and thereafter every 2 months they will be analyzed for their capacity to act as surrogate markers of treatment activity)