NCT00401609已完成1 期
Evaluation of Activity and Toxicity of Polychemotherapy With 2-drug Combinations Containing Gemcitabine as First Line Treatment of Elderly Patients With Small Cell Lung Cancer
National Cancer Institute, Naples32 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2000年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 32
- 主要终点
- to identify optimal dose of GEMETO, GEMCAR, and GEMCIS combinations
研究概览
简要总结
The purpose of this study is to describe the activity and toxicity of gemcitabine combined with four different drugs (carboplatin or cisplatin or etoposide or vinorelbine) as first line treatment of elderly patients with extensive small cell lung cancer.
详细描述
Four treatment arms are planned.
- GEMVIN: gemcitabine 1000 mg/m2 and vinorelbine 25 mg/m2 on days 1 & 8, every 21 days
- GEMCAR: gemcitabine 1000 on days 1 & 8 and carboplatin AUC 3.5 or 4 or 4.5 on day 1, every 21 days
- GEMCIS: gemcitabine 1000 mg/m2 on days 1 & 8 and cisplatin 50 or 60 or 70 mg/m2 on day 1, every 21 days
- GEMETO: gemcitabine 1000 mg/m2 on days 1 & 8 and etoposide 60 or 70 or 80 mg/m2 on days 1,2,3 every 21 days
For the study of the GEMVIN combination a two-stage minimax flexible design will be applied. For the remaining 3 combinations (GEMCAR, GEMCIS, GEMETO) a phase 1/2 design aimed at looking for optimal dose within a Bayesian framework will be applied.
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
- •Histologic or cytologic diagnosis of SCLC
- •Extensive disease
- •Measurable disease
- •Performance Status (ECOG) < o = 2
- •Age > o = 70 years.
- •Written informed consent.
排除标准
- •Previous chemotherapy.
- •Previous or concomitant malignancies (with the exception of adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix)
- ••Neutrophils<2.000/mm3;platelets<100.000/mm3; hemoglobin < 10 g/dl
- •Creatinine > 1.5 time the upper limit
- •AST, ALT > 2.5 times and/or bilirubin > 1.5 time the upper limit of normal if liver metastases are absent or AST, ALT ³5 times and bilirubin > 3 times the upper limit of normal if liver metastases are present
- •Symptomatic brain metastases
结局指标
主要结局
to identify optimal dose of GEMETO, GEMCAR, and GEMCIS combinations
to evaluate activity and toxicity of GEMETO, GEMCAR, and GEMCIS combinations
to evaluate activity and toxicity of GEMVIN combination
次要结局
- treatment impact on patient quality of life
- clinical variables predictive of response to treatment
- prognostic value of ADL and IADL multidimensional geriatric evaluation scales
研究者
研究点 (32)
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