EUCTR2004-000864-29-CZ进行中（未招募）不适用
A randomized, double-blind multicenter phase III study of bevacizumab in combination with cisplatin and gemcitabine versus placebo, cisplatin and gemcitabine in patients with advanced or recurrent non-squamous non-small cell lung cancer, who have not received prior chemotherapy - Avail
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,050
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
- •Age 18 years or over
- •Able to comply with the protocol
- •Histologically or cytologically documented inoperable, locally advanced (stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent non-squamous NSCLC (NOTE: In cases where the diagnosis is based on cytology only, representative samples have to be sent to Roche for central review. Patients for whom no representative samples can be sent should not be entered into the trial. Results of the review do not have to be awaited for randomization and treatment of the patient. Sputum cytology alone is not acceptable). Mixed tumors should be categorized according to the predominant cell type.
- •ECOG performance status 0-1
- •Life expectancy > 12 weeks
- •Adequate hematological function : ANC greater than or equal to 1.5 x 10^9/L; platelets greater than or equal to 100 x 10^9/L, Hb greater than or equal to 9 g/dL
- •INR less than or equal to 1.5 and PTT less than or equal to 1.5 x ULN within 7 days prior to starting study treatment
- •Adequate liver function: Serum bilirubin less than or equal to 1.5 x ULN; transaminases less than or equal to 2.5 x ULN (in case of liver metastases < 5 x ULN)
- •Adequate renal function:
- •oCreatinine clearance, measured and/or calculated according to the formula of Cockroft and Gault greater than or equal to 60 ml/min AND
- •oUrine dipstick for proteinuria < 2+. If urine dipstick is greater than or equal to 2+, 24- hour urine must demonstrate less than or equal to 1 g of protein in 24 hours
- •Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women < 2 years after the onset of menopause
- •Written informed consent
- •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
- •Prior chemotherapy or treatment with another systemic anti-cancer agent (for example monoclonal antibody, tyrosine kinase inhibitor) NOTE: prior surgery and irradiation is permitted
- •Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
- •History of = grade 2 hemoptysis (bright red blood of at least ½ 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 or radiotherapy within the last 4 weeks prior to first dose of study treatment or anticipation of the need for major surgery during study treatment
- •Palliative radiotherapy for bone lesions outside the thoracic region within 2 weeks prior to the first dose of study treatment
- •Pregnant or lactating women
- •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)
- •Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, DCIS treated surgically with curative intent
- •Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to starting study treatment
- •Known hypersensitivity to any of the study drugs
- •Non healing wound, ulcer or bone fracture
- •History of thrombotic or hemorrhagic disorders
- •Uncontrolled hypertension
- •Clinically significant cardiovascular disease for example CVA (less than or equal to 6 months before randomization), myocardial infarction (less than or equal to 6 months before randomization), unstable angina, NYHA greater than or equal to grade 2 CHF, arrhythmia requiring medication
- •Current or recent (within 10 days of first dose of study treatment) use of aspirin (> 325 mg/day) 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
研究者
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