EUCTR2007-007949-13-IT进行中（未招募）不适用
Multicenter phase III randomized study of cisplatin and etoposide with or without bevacizumab as first-line treatment in extensive stage (ED) small cell lung cancer (SCLC) - ND
GRUPPO ONCOLOGICO ITALIANO DI RICERCA0 个研究点开始时间: 2008年10月8日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •·The patient must give written (personally signed and dated) informed consent before completing any study related procedure;
- •·Histologically or cytological documented extended SCLC, including malignant pleural effusion;
- •·Males or females, age >= 18 years;
- •·ECOG performance status <= 2;
- •·Life expectancy > 12 weeks;
- •·No prior systemic chemotherapy, immunotherapy or biological therapy for SCLC;
- •·Prior radiation therapy allowed to < 25% of the bone marrow. Patients who have received prior radiation to chest for the treatment of SCLC are not eligible. Prior radiotherapy must be completed at least 2 weeks before study enrolment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrolment;
- •·Adequate haematological, hepatic and renal functions;
- •·At baseline, presence of at least one measurable target lesion (according to RECIST criteria); all radiology studies must be performed within 28 days prior to randomization;
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomisation in the trial.
- •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
- •·Mixed histological diagnosis of SCLC and NSCLC;
- •·History of ≥ grade 2 haemoptysis (bright red blood of at least œ teaspoon);
- •·Brain metastases or spinal cord compression (CT or MRI of the head is required within 4 weeks prior to randomization).
- •·Evidence of tumor invading or abutting major blood vessels;
- •·Surgery (including open biopsy), significant traumatic injury within the last 4 weeks prior to first dose of study treatment or anticipation of the need for major surgery during study treatment;
- •·Other malignancies (previous or current), except for adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, localized prostate cancer surgically treated with curative intent or ductal carcinoma in situ treated surgically treated with curative intent or if previous malignancy was more than 5 years prior and there are no signs or symptoms of recurrence;
- •·Patients with any underlying medical condition that might be aggravated by treatment or which cannot be controlled i.e. patients with active serious infection, diabetes mellitus, patients with concurrent heart failure [New York Heart Association (NYHA) class II-III-IV], or with progressive or unstable angina, patients who have had myocardial infarction within 6 months, and/or poorly controlled hypertension, or pericardial effusion;
- •·Concomitant treatment with any other anti-cancer drug;
- •·Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to starting study treatment;
- •·Known hypersensitivity to the study drugs or to drugs with similar chemical structures;
- •·Non healing wound, ulcer or bone fracture;
- •·History of thrombotic or hemorrhagic disorders;
- •·Uncontrolled hypertension;
- •·Current or recent (within 10 days of first dose of study treatment) use of aspirin (> 325 mg/day) or other NSAID with anti-platelet activity or treatment with dipyramidole, ticlopidine, clopidogrel and cilostazol;
- •·Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes;·Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug or puts the patient at high risk for treatment-related complications;·For female patients, pregnancy and/or breast-feeding. Fertile men or woman of childbearing potential not using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).
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