EUCTR2006-002485-19-BE进行中（未招募）1 期
Phase II study of sunitinib (SU011248) in patients with small cell lung cancer who are either chemo-naïve (extensive disease) or have a sensitive relapse
EORTC-European Organisation for Research and Treatment of Cancer0 个研究点目标入组 48 人开始时间: 2008年9月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •¨ Histologically proven small cell lung cancer
- •¨ Chemotherapy naïve or sensitive relapse (that is, off first line treatment > 3 months)
- •¨ Presence of measurable disease, as defined in the RECIST criteria (see chapter on Response evaluation).
- •¨ Extensive disease when chemotherapy naïve
- •¨ Age > 18 years
- •¨ WHO PS 0-2
- •¨ Life expectancy > 12 weeks
- •¨ Adequate organ function as defined by the following criteria:
- •- Absolute neutrophil count (ANC) = 1.5 x 109/L
- •- Platelets = 100 x 109/L
- •- Serum asparatate aminotransferase (AST; serum glutamate-oxalate transferase (SGOT)) and serum aminotransferase (ALT; serum glutamate-pyruvate transferase (SGPT)) = 2.5 x upperlimit of normal (ULN), or AST and ALT = 5 x ULN if liver function abnormalities are due to underlying malignancy.
- •- Total serum bilirubin = 1.5 x ULN
- •- Serum albumin = 3.0 g/dL
- •¨ For women: patient must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; they also must have a negative serum or urine pregnancy test performed within 28 days before registration and must not be lactating.
- •¨ For men: patient must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period.
- •¨ Written informed consent must be given according to ICH/GCP, and national/local regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •¨ Brain metastases (according to CT or MRI scan performed not earlier than one week prior to the start of treatment)
- •¨ Prior chemotherapy, radiation therapy, surgery or investigational agent within 4 weeks prior to study entry except for palliative radiotherapy to non-target lesions.
- •¨ Prior treatment with sunitinib (SU011248) or other receptor tyrosinekinase inhibitors
- •¨ Spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. Patients should be off radiotherapy for at least 1 month and be off treatment with steroids
- •¨ Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus within 6 months prior to starting study treatment
- •¨ NCI CTCAE grade 3 hemorrhage within 4 weeks before the start of the treatment
- •¨ Hypertension ( > 150/100 mm Hg) that cannot be controlled with standard antihypertensive agents.
- •¨ Ongoing cardiac dysrhythmias of grade = 2, atrial fibrillation of any grade, or QTc interval > 450 msec for males or > 470 msec for females.
- •¨ Other severe acute or chronical medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
- •¨ Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
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