A Phase II Study of Docetaxel Combined With Cisplatin as the First Line Chemotherapy in Patients With Metastatic Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
This is a phase II, open-label clinical study prospectively enrolling 40 metastatic patients with non small cell lung cancer. The study will enroll patients at King Abdulaziz Medical City, Riyadh.
Sub-sites will be open for patient accrual in selected centers in the Kingdom.
详细描述
The cisplatin/docetaxel is established standard in the first line management of metastatic non small cell lung cancer in the United States, Europe and Asia. However, the safety and efficacy of this regimen was not studied systematically in Middle Eastern population. The aim of this study is to study the efficacy and safety of this regimen in our patient population
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
- •Histologically or cytologically proven non-small cell lung carcinoma
- •Stage IV metastatic non-small cell lung carcinoma or stage III with malignant pleural effusion.
- •Patient should not be eligible for customization chemotherapy (if available at participating institutions).
- •Having at least one measurable lesion
- •Patient has life expectancy of 12 weeks or greater.
- •Age > 18 years.
- •No prior systemic treatment for metastatic lung cancer. Adjuvant treatment given more than 1 year ago is acceptable.
- •WHO performance status 0-2 (See Appendix III )
- •Adequate organ function:
- •Hematology: Neutrophils > 2 x 10 9 /L, platelets > 100 x 10 9 /L
- •Hepatic function: Total bilirubin < 1.25 times the upper normal limits, ASAT (SGOT) < 2 times the upper normal limits
- •Renal function: Creatinine < 1.5 mg/dL; if value is higher than upper normal limit but less than 2 mg/dL, the creatinine clearance should be > 60min/ml.
- •Able to comply with scheduled follow-up and with management of toxicity
- •Signed informed consent from patient or legal representative
- •Negative urine pregnancy test (if indicated)
排除标准
- •Pregnant or lactating women or women of childbearing potential using inadequate contraception.
- •Uncontrolled brain metastatic disease. (CNS disease that is stable > 4 weeks after radiotherapy in lieu of steroids reduction is eligible).
- •Symptomatic peripheral neuropathy > grade 1 according to the NCI Common Toxicity Criteria Version 3
- •Other serious illness or medical condition:
- •Unstable cardiac disease requiring treatment
- •History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures
- •Active uncontrolled infection
- •Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening
- •Concurrent treatment with any other anti-cancer therapy
- •Contraindication of steroid drug administration
- •Past (up to 5 years) or concurrent history of other neoplasm except curatively treated non- melanoma skin cancer or in situ carcinoma of the cervix
研究组 & 干预措施
Cisplatin, Docetaxel
Each cycle of chemotherapy administration will be started with docetaxel at dose of 75 mg/m2 in 250 ml of D5W or NS administered as a 1-hour intravenous infusion, followed by cisplatin at dose of 75 mg/m2administered as a 2-hour intravenous infusion every 3 weeks per cycle for 4-6 cycles
干预措施: cisplatin, docetaxel (Drug)
结局指标
主要结局
Efficacy
时间窗: 3 years
Efficacy will be measured by calculating the following: * Response rate using Response Evaluation Criteria for Solid Tumor criteria * Time to Disease progression or Death * Overall Survival
次要结局
- Progression free survival, safety(3 years)