NCT00475657终止2 期
Phase II Study of Pemetrexed Plus Cisplatin in the Treatment of Patients With Extensive Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
The purpose of this study is to determine if cisplatin and pemetrexed are effective in the treatment of patients with Small Cell Lung Cancer, extended disease.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of Small Cell Lung Cancer (SCLC).
- •Functional stage from 0 to 2 of the ECOG functional scale
- •No previous systemic chemotherapy, immunotherapy or biologic therapy for SCLC.
- •Previous bone marrow radiotherapy less than 25% is allowed.
- •There must be at least one measurable lesion that complies with the solid tumor response evaluation criteria.
- •Appropriate organic function.
- •Life expectancy estimated at 12 weeks minimum.
- •Females must be surgically sterile, postmenopausal or follow approved medical contraceptive methods during the treatment period and 6 months afterwards. Males must be surgically sterile or use a contraceptive method during the treatment period and during 6 months after treatment.
- •The patient must be compliant and located close to the trial area for appropriate follow-up.
- •The patient or his/her legal representative must sign an informed consent document.
- •Patients must be at least 18 years of age.
排除标准
- •Having received treatment for the last 30 days with a drug that has not obtained regulatory approval.
- •Having participated in a previous pemetrexed trial.
- •Mixed histologic diagnosis of SCLC and NSCLC.
- •Concurrent illness.
- •Having an active infection.
- •Severe cardiac disease.
- •Having received recently or concurrently a vaccine against yellow fever.
- •Having suffered a previous malignant process other than SCLC.
- •Central nervous system (CNS) metastases require concurrent corticoid therapy. Treated and stable CNS metastases are allowed.
- •Clinically relevant fluid accumulation in the third space.
- •Significant weight loss (greater than or equal to 10%) within 6 weeks prior to trial inclusion.
- •Concurrent administration of any other anti-tumor treatment.
- •Severe renal failure.
- •Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS) agents.
- •Inability or unwillingness to take folic acid and vitamin B12 supplements.
- •Inability to take corticoids.
研究组 & 干预措施
A
Experimental
干预措施: pemetrexed (Drug)
A
Experimental
干预措施: cisplatin (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: baseline to measured progressive disease
Trial terminated - results not analyzed
次要结局
- Overall Survival(baseline to date of death from any cause)
- Progression Free Survival(baseline to measured progressive disease)
- Duration of Response(time of response to progressive disease)
- Stable Disease Rate(baseline to measured progressive disease)
研究者
研究点 (1)
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