Randomized Phase II Study of Combination Chemotherapy With Sildenafil Plus Carboplatin and Weekly Paclitaxel in Patients With Previously Untreated Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
A comparison of combination chemotherapy of sildenafil plus carboplatin and weekly taxol with carboplatin and weekly taxol in patients with previously untreated advanced non-small cell lung cancer. The study hypothesis is that sildenafil may improve the distribution and efficacy of cytotoxic anticancer agents.
详细描述
Sildenafil is one of selective phosphodiesterase type 5 inhibitors. It is used to block the degradative action of phosphodiesterase type 5 on cyclic GMP in the smooth muscle cells lining the blood vessels, which leads to smooth muscle relaxation in blood vessels and increases blood flow. Because phosphodiesterase type 5 is also present in the arterial wall smooth muscle within the lungs, phosphodiesterase type 5 inhibitors is also used for the treatment of pulmonary hypertension.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of histologically confirmed stage IIIB or IV non-small cell lung cancer
- •Good performance status (ECOG 0-1)
- •No previous treatment
- •Adequate bone marrow, liver and renal functions
- •Must be able to swallow tablets
- •Provided written informed consent
排除标准
- •Severe complications or a concomitant malignancy
- •Contraindicated sildenafil, carboplatin or taxol
- •Inappropriate patients for entry to this study, judged by the physicians
研究组 & 干预措施
A
Sildenafil plus carboplatin and weekly paclitaxel
干预措施: sildenafil (Drug)
A
Sildenafil plus carboplatin and weekly paclitaxel
干预措施: paclitaxel (taxol) (Drug)
A
Sildenafil plus carboplatin and weekly paclitaxel
干预措施: carboplatin (palaplatin) (Drug)
P
carboplatin and weekly paclitaxel
干预措施: placebo (Drug)
P
carboplatin and weekly paclitaxel
干预措施: paclitaxel (taxol) (Drug)
P
carboplatin and weekly paclitaxel
干预措施: carboplatin (palaplatin) (Drug)
结局指标
主要结局
progression free survival
时间窗: three-year
次要结局
- overall response rate(three-year)
研究者
Naoki Inui
Department of Respiratory Medicine
Hamamatsu University