NCT03127319Unknown2 期
A Study of Apatinib Plus Docetaxel for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With Bone Metastases
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib plus docetaxel and zoledronic versus docetaxel and zoledronic alone as second line treatment for advanced non-squamous non-small cell lung cancer with bone metastases.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18 to 75 years old (man or female)
- •Pathologically diagnosed with metastatic or recurrent non-squamous non-small cell lung cancer
- •Patients with at least one evaluate lesions of the lung and bone metastases.(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1 and WHO)
- •Refractory or failure of prior therapy
- •Life expectancy greater than or equal to 3 months
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Major organ function has to meet the following criteria:
- •For results of blood routine test (without blood transfusion within 14 days)
- •ANC≥1.5×109/L
- •PLT≥180×109/L
- •For results of blood biochemical test：
- •TBIL<1.5×ULN；
- •ALT and AST<2.5×ULN, but< 5×ULN if the transferase elevation is due to liver metastases；
- •Serum creatinine ≤1.25×ULN , or calculated creatinine clearance>45 ml/min(per the Cockcroft-Gault formula);
- •Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;
- •Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
排除标准
- •Allergic to apatinib and docetaxel;
- •Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with class Ⅱ and above coronary heart disease, arrhythmia (including QTc lengthened men > 450 ms, women > 470 ms) and class Ⅲ-Ⅳ cardiac insufficiency;
- •A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.).
- •Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months; For defecate occult blood (+) and primary lesions without surgical removal of the stomach tumor, requirement of gastroscopy, such as ulcer type of gastric cancer, and researchers think that may be gastrointestinal hemorrhage;
- •Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency.
- •Patients with symptoms of central nervous system metastasis.
- •Pregnant or lactating women.
- •history of psychiatric drugs abuse and can't quit or patients with mental disorders.
- •Less than 4 weeks from the last clinical trial.
- •The researchers think inappropriate.
研究组 & 干预措施
apatinib and docetaxel zoledronic
Experimental
apatinib 500mg qd po; docetaxel 60mg/m² iv q3w; zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: apatinib docetaxel zoledronic (Drug)
docetaxel zoledronic
Active Comparator
docetaxel 60mg/m² iv q3w;zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: docetaxel zoledronic (Drug)
结局指标
主要结局
Progression free survival
时间窗: evaluation per 2 cycles (6 weeks)
次要结局
- Overall survival(evaluation per 2 cycles (6 weeks))
- SREs（Skeletal-related events）(evaluation per 2 cycles (6 weeks))
- DCR (Disease control rate)(evaluation per 2 cycles (6 weeks))
- Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0(evaluation per 2 cycles (6 weeks))
- ORR (Objective response rate)(evaluation per 2 cycles (6 weeks))
研究者
Aimin Zang
Director of oncology
Affiliated Hospital of Hebei University
研究点 (1)
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