NCT01656551进行中（未招募）3 期
A Factorial Study Comparing Pemetrexed With Gemcitabine and Testing the Efficacy of the Addition of Cisplatin in Elderly Patients With Non Squamous Advanced, Metastatic or Recurrent NSCLC.
National Cancer Institute, Naples48 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 232
- 试验地点
- 48
- 主要终点
- overall survival
研究概览
简要总结
The purposes of this study are to test whether the addition of cisplatin to single agent chemotherapy (either gemcitabine or pemetrexed) prolongs survival in elderly patients with non squamous non small cell lung cancer (NSCLC), and to test whether pemetrexed prolongs survival as compared to gemcitabine in elderly patients with non squamous NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Diagnosis of cytologically or histologically confirmed non-small cell lung cancer.
- •Non squamous tumor type (including those with a non-specified tumor type).
- •Metastatic (stage IV, both M1A or M1B) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes) according to TNM VII edition.
- •Both patients at first diagnosis or those with disease recurrence after former surgery are eligible.
- •At least one target or non-target lesion according to RECIST revised version 1.
- •Male or female > or = 70 years of age.
- •ECOG PS 0 or
- •Life expectancy > 3 months.
- •Neutrophils > or = 1500 mm3, platelets > or = 100000 mm3, and haemoglobin > or = 9 g/dL.
- •Bilirubin level either normal or < 1.5 x ULN.
- •AST (SGOT) and ALT (SGPT) < or = 2.5 x ULN (< or = 5 x ULN if liver metastasis are present).
- •Serum creatinine < 1.5 x ULN.
- •Signed written informed consent.
排除标准
- •Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease. Prior surgery and/or localised irradiation is permitted. Prior adjuvant chemotherapy is permitted if it did not contain gemcitabine and pemetrexed and if at least 6 months elapsed from the end of adjuvant chemotherapy.
- •Any unstable systemic disease (including active infections, significant cardiovascular disease or myocardial infarction within the previous year, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medications or render the patient at high risk from treatment complications.
- •Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA).
- •Patients with symptomatic brain metastasis or spinal cord compression that has not yet been treated with surgery and/or radiation; patients with CNS metastases or spinal cord compression previously treated with surgery and/or radiation are eligible if they are asymptomatic and do not require steroids (anti-seizure medications are allowed).
- •Known or suspected hypersensitivity to any of the study drugs
研究组 & 干预措施
C: Pemetrexed
Active Comparator
干预措施: Pemetrexed (Drug)
D: Pemetrexed + Cisplatin
Experimental
干预措施: Pemetrexed (Drug)
D: Pemetrexed + Cisplatin
Experimental
干预措施: Cisplatin (Drug)
A: Gemcitabine
Active Comparator
Single agent gemcitabine dose 1200 mg/m2 days 1 and 8, every 3 weeks
干预措施: Gemcitabine (Drug)
B: Gemcitabine + Cisplatin
Experimental
Gemcitabine dose 1000 mg/m2 days 1 and 8, every 3 weeks
干预措施: Gemcitabine (Drug)
B: Gemcitabine + Cisplatin
Experimental
Gemcitabine dose 1000 mg/m2 days 1 and 8, every 3 weeks
干预措施: Cisplatin (Drug)
结局指标
主要结局
overall survival
时间窗: one year
factorial design with two comparisons: single agent chemotherapy versus chemotherapy plus cisplatin (Arms A+C versus Arms B + D), and gemcitabine versus pemetrexed (Arms A+B versus Arms C+D)
次要结局
- objective response(after 9 and 18 weeks of therapy)
- changes in quality of life(baseline and up to 18 weeks)
- worst grade toxicity per patient(evaluated at end of each 3 week cycle of chemotherapy up to 18 weeks)
- progression free survival(6 months)
研究者
研究点 (48)
Loading locations...
相似试验
已完成
2 期
A Phase II Study of Pemetrexed Plus Gemcitabine for Metastatic/Recurrent Head and Neck Cancer (HNSCC)Head and Neck CancerNCT00589667Memorial Sloan Kettering Cancer Center26
终止
2 期
Pemetrexed and Cisplatin as Treatment in Small Cell Lung CancerSmall Cell Lung CancerNCT00475657Eli Lilly and Company5
撤回
1 期
Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural MesotheliomaMalignant Pleural MesotheliomaNCT02639767Memorial Sloan Kettering Cancer Center
终止
2 期
Pemetrexed and Gemcitabine in Patients With Advanced Head and Neck CancerHead and Neck CancerNCT00394147Fox Chase Cancer Center17
已完成
2 期
Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-SmokersNon-small Cell Lung CancerNCT00409006Eli Lilly and Company70