A Randomized Phase II Study of Progression Free Survival Comparing Gemcitabine (1000 mg/m2 Infusion) Versus Carboplatin (AUC5 Infusion) Plus Alimta (500 mg/m2 Infusion) as First-line Chemotherapy in Elderly Patients With Locally Advanced (Stage IIIb) or Metastatic (Stage IV) Non Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Evaluate Progression Free Survival of Carboplatin plus Alimta vs gemcitabine in chemonaive, elderly stage IIIB-IV NSCLC patients.
研究概览
简要总结
Between 10% and 25% of newly diagnosed stage IIIB/stage IV patients currently receive single agent chemotherapy regimens. A significant proportion of these patients will be elderly (70 years of age) and many oncologists would consider intravenous vinorelbine or gemcitabine to be the standard of care in this patient population. It has been demonstrated that single agent vinorelbine offers therapeutic advantages to selected NSCLC patients over best supportive care alone.
Carboplatin plus Alimta have an acceptable toxicity profile and few clinical problems so it could be acceptable its use in elderly patients.
A randomised study is being performed therefore to assess whether progression free survival, the primary efficacy endpoint for this study, achieved with Carboplatin plus Alimta is superior than achieved with gemcitabine, one of the current standards of care in elderly patients with advanced NSCLC.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSCLC, locally advanced (stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
- •Female or male patients aged 70 years and over
- •Measurable disease according to RECIST criteria, with at least one measurable lesion
- •No prior chemotherapy, biological or immunological therapy
- •Adeguate hepatic, renal and bone marrow function
- •ECOG Performance Status ≤ 2
- •Life expectancy of at least 12 weeks
排除标准
- •Newly diagnosed CNS metastases that have not been treated with surgery or radiation
- •Less than 4 weeks since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
- •Any other experimental or anti-cancer therapy within 30 days before study drug administration
- •Concurrent treatment with any other experimental or anti-cancer therapy
研究组 & 干预措施
Pemetrexed/Carboplatin
Pemetrexed (500 mg/m2 infusion) plus Carboplatin (AUC5 infusion)
干预措施: Pemetrexed/Carboplatin (Drug)
Gemcitabine
Gemcitabine 1250 mg/mq
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Evaluate Progression Free Survival of Carboplatin plus Alimta vs gemcitabine in chemonaive, elderly stage IIIB-IV NSCLC patients.
时间窗: Efficacy after the inclusion of the last patient
次要结局
- Overall Survival Quality of life(After the follow up period)
研究者
Armando Santoro, MD
MD
Istituto Clinico Humanitas