An Open Label Pilot Study of NovoTTF-100L in Combination With Pemetrexed (Alimta®) for Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Device related toxicity
研究概览
简要总结
An open-label phase I-II trial will be performed in 42 patients with pretreated locally advanced non-small cell lung cancer. The trial is designed to estimate the efficacy and to determine safety of NovoTTF-100L treatment combined with Pemetrexed for advanced NSCLC patients. Patients will receive standard Pemetrexed therapy (at 500 mg/m2 iv q3w for 3 cycles) concomitant to NovoTTF-100L therapy (12 hours a day, daily until the end of all three cycles of Alimta). Repeat treatments with Alimta + NovoTTF-100L will be offered as long as the patient is stable or responding. If there is a in-field response with progression outside of the NovoTTF field, Pemetrexed is to be stopped and third line chemotherapy with Docetaxel is to be initiated (35 mg/m2 weekly, d1, 8, 15, q 28 d).
详细描述
The trial will be conducted in two stages. Fourteen patients will be recruited to a phase I stage of the trial. After all 14 patients have received 3 courses of Alimta (9 weeks of NovoTTF-100L treatment), these patients will be analyzed for toxicity. If the incidence of device related serious adverse events is < 20%, the trial will continue to the second stage where 42 patients will be assessed for safety and efficacy as part of a phase II study (including the first 14 patients in the phase I study).
Efficacy will be assessed based on local disease control in the lungs and liver, time to systemic disease progression, and overall survival. Patients will be followed for at least 6 months after the last course of NovoTTF-100L is applied to assess survival.
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
- •Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- •Stage IV or IIIB with malignant pleural effusion, also locally advanced NSCLC not otherwise amenable to local treatment (surgery or radiotherapy)
- •One line of prior chemotherapy
- •Measurable disease
- •Greater or equal to 18 years
- •Life expectancy of at least 12 weeks
- •ECOG performance status 0-2
- •Laboratory requirements at entry:
- •Blood cell counts:
- •Absolute neutrophils ≥ 1.0 x 109/L
- •Platelets ≥100 x 109/L
- •Hemoglobin ≥ 10 g/dl
- •Renal function:
- •Creatinine clearance ≥ 45 mL/min
- •Hepatic functions:
- •ASAT and ALAT ≤ 3 x UNL
- •Alkaline phosphatase ≤ 5 x UNL
- •Signed informed consent prior to start protocol specific requirements
- •Pregnancy test (β-HCG) must be negative (needed only for women of childbearing potential).
排除标准
- •Known brain metastases or meningeal carcinomatosis
- •Other serious concomitant illness of medical conditions:
- •Congestive heart failure or angina pectoris except if it is medically controlled.
- •Previous history of myocardial infarction within 1 year from study entry.
- •Uncontrolled hypertension or arrhythmias
- •Implanted pacemaker, defibrillator or deep brain stimulation device
- •History of significant neurologic or psychiatric disorders including dementia or seizures
- •Active infection requiring iv antibiotics
- •Active ulcer, unstable diabetes mellitus or other contra-indication to corticosteroid therapy
- •Concurrent treatment with other experimental drugs
- •Participation in clinical trials with other experimental agents within 30 days of study entry
- •Psychological, familial, sociological or geographical conditions which don't permit medical follow-up and compliance with the study protocol
结局指标
主要结局
Device related toxicity
时间窗: until 2 months after treatment termination
次要结局
- Time to progression(Six months after recruitment of the last patient in the trial)