EUCTR2008-000662-23-ES进行中（未招募）不适用
Estudio en fase II aleatorizado y multicéntrico para investigar si los biomarcadores están relacionados con el resultado del tratamiento en pacientes con cáncer de pulmón no microcítico y no epidermoide, avanzado o recurrente que no han recibido quimioterapia previa, tratados con bevacizumab (en dosis de 7,5 mg/kg o 15 mg/kg) añadido a quimioterapia basada en el carboplatino (gemcitabina o paclitaxel)A randomized, multicenter phase II study to explore whether biomarkers correlate with treatment outcome in chemo-naive patients with advanced or recurrent non-squamous non-small cell lung cancer, who receive treatment with bevacizumab (at a dose of either 7.5 mg/kg or 15 mg/kg) in addition to carboplatin based chemotherapy (gemcitabine or paclitaxel)
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
- 300
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 above
- •Life expectancy > 12 weeks
- •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. Diagnoses of non-squamous NSCLC based on sputum cytology alone are not acceptable. Mixed tumors should be categorized according to the predominant cell type.
- •At least one measurable tumor lesion according to the RECIST criteria
- •ECOG performance status 0-1
- •Adequate hematological function: ANC = 1.5 x 109/L; platelets = 100 x 109/L, Hb = 9 g/dL
- •INR < or = 1.5 (or PT within normal range) and aPTT < or = 1.5 x ULN within 7 days prior to starting study treatment
- •Adequate liver function: Serum bilirubin < or = 1.5 x ULN; transaminases < or = 2.5 x ULN (in the presence of liver metastases :< 5 x ULN)
- •Adequate renal function:
- •Creatinine clearance, measured and/or calculated according to the formula of Cockroft and Gault = 50 mL/min AND
- •Urine dipstick for proteinuria < 2+. If urine dipstick is = 2+, 24- hour urine must demonstrate < or = 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
- •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 antibodies, tyrosine kinase inhibitors) NOTE: prior surgery is permitted if the criteria below do not apply:
- •Surgery (including open biopsy) or significant traumatic injury within the last 4 weeks prior to first dose or anticipation of the need for major surgery during study treatment.
- •Minor surgical procedures within 2 days prior randomization
- •Radiotherapy within the 4 weeks prior to the first dose
- •Patients who have had radiotherapy = 4 weeks prior to the first dose of study treatment, but are experiencing acute toxic effects of radiotherapy
- •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 2.5 mL)
- •History of peripheral sensory neuropathy of Grade 2 or more
- •Evidence of CNS metastases, even if previously treated.
- •Evidence of tumor invading or abutting major blood vessels
- •Pregnant or lactating women
- •Fertile men or women of childbearing potential not using adequate contraception
- •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 (including peptic ulcer) or bone fracture •History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- •Active gastrointestinal bleeding
- •Uncontrolled hypertension systolic > 150 mmHg and/or diastolic > 100 mmHg
- •Clinically significant cardiovascular disease to include but not restricted to for example CVA (< or = 6 months before randomization), myocardial infarction (< or = 6 months before randomization), unstable angina, NYHA =grade 2 CHF, arrhythmia uncontrolled by medication
- •Current or recent (within 10 days of first dose) use of aspirin (> 325 mg/day) clopidogrel > 75 mg/day, or treatment with dipyramidole, ticlopidine, and cliostazol
- •Current or recent (within 10 days prior to study treatment start) use of full dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (not 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 of treatment-related conditions
- •Increased risk of gastrointestinal perforation, hypertension, would healing complications, thromboembolism or hemorrhage (for thromboembolism and hemorrhage risk, this concerns risks other than those related to NSCLC per se)
- •Active infection requiring iv antibiotics at randomization
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of randomization.
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