Phase II Trial of First Line Docetaxel and Oxaliplatin in Stage IV or Relapsed Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
Lung cancer is the leading cause of cancer death in Korea as well as in other countries. About 80% of lung cancer is non-small cell lung cancer(NSCLC). The majority of patients with NSCLC require cytotoxic chemotherapy in the course of their illness. Combination chemotherapy using third generation anticancer drugs (paclitaxel, docetaxel, gemcitabine) with platinums(cisplatin or carboplatin) reached a plateau in their efficacy. Oxaliplatin, another platinum being used for colorectal, gastric and pancreatic cancer has lower adverse effects such as nausea and nephrotoxicity. In this phase II trial, we will observe efficacy and safety of docetaxel and oxaliplatin for patients with NSCLC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage IIIB/IV or Relapsed NSCLC
- •Age >= 18 years
- •At least one measurable lesion by RECIST (version 1.1)
- •ECOG PS 0, 1, 2
- •Hematologic profile
- •Hgb > 8 g/dL, ANC >= 2,000/m3, Platelet >= 100,000/m3
- •Hepatic profile
- •Total bilirubin <= 1.5 x upper normal value
- •Transaminases <= 3 x upper normal value <= 5 x upper normal value in case of liver metastasis
- •Creatinine <= 1.5mg/dL
- •Patients should be recovered from toxicities of previous treatment.
- •Written informed consent by patient or surrogates
排除标准
- •Patients who had been previously treated with chemotherapy for NSCLC
- •Active infection requiring antibiotics treatment
- •Prior diagnosis of other malignancy except radically treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the uterine cervix
- •Peripheral neuropathy >= grade 2 by NCI CTCAE 4.0
- •Uncontrolled hypertension, Acute myocardial infarction within 6 months Unstable angina, Congestive heart failure >= NYHA grade 2 Uncontrolled significant arrhythmia
- •Patients who entered other clinical trials within 4 weeks
- •Pregnant or lactating women. women with child bearing age who are not willing to a contraceptive measure
研究组 & 干预措施
Belotaxel plus Belloxa
Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
干预措施: Belotaxel (Drug)
Belotaxel plus Belloxa
Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
干预措施: Belloxa (Drug)
结局指标
主要结局
Response Rate
时间窗: 6th week
RECIST version 1.1
次要结局
- Progression Free Survival(2 years)
- Overall Survival(2 years)
- Neutropenia Grade 3-4(2 years)
研究者
Young-Chul Kim
Professor
Chonnam National University Hospital