Phase II Trial of Geriatric Evaluation as Selection Criteria and Predictive Factor of Safety in Elderly Patients (≥ 70 Years) With Non-small Cell Lung Cancer (NSCLC)That Can be Treated With Bevacizumab, Carboplatin and Paclitaxel
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 18
- 主要终点
- Rate of grade 3-4 neutropenia defined according to National Cancer Institute Common Terminology Criteria version 4.0 (NCI-CTC v4.0)
研究概览
简要总结
A phase II Study of an adapted chemotherapy regimen plus bevacizumab in elderly non-small cell lung cancer patients selected by geriatric assessment
详细描述
CRITERIOS INCLUSION
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Written informed consent confirming that the patient understands the study objective and the procedures required.
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Patients must be able to accomplish with the study protocol.
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Men and women ≥70 years old.
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Histologically or cytologically confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC) with EGFR gen mutational status negative or non-determinable.
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Patients with stage IV disease.
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Patients who have not received first-line treatment
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Patients with ECOG performance status 0 or 1.
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Adequate bone marrow function, defined as:
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Absolute neutrophil count (ANC) ≥1.500/mm3 or ≥1.5x109/L;
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Hemoglobin ≥ 9 g/dL.
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Platelet count ≥ 100.000/mm3.
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Adequate renal function, defined as:
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Creatinine clearance ≥ 40 ml/min, according to MDRD formula.
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Urine dipstick proteinuria <2+. If urine dipstick for proteinuria ≥2+ 24 hours urine must be collected within 24 hours, and proteins must be less than 1 g.
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Fertile males must use an effective contraceptive method (error rate per year <1%) during the trial and until 6 months after the last study treatment dose, such as sexual abstinence, previous vasectomy and/or having a partner using any of following methods: implantables, injections, combined oral contraceptives and/or intrauterine device (hormonal only).
CRITERIOS EXCLUSION
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent confirming that the patient understands the study objective and the procedures required.
- •Patients must be able to accomplish with the study protocol.
- •Men and women ≥70 years old.
- •Histologically or cytologically confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC) with EGFR gen mutational status negative or non-determinable.
- •Patients with stage IV disease.
- •Patients who have not received first-line treatment
- •Patients with ECOG performance status 0 or
- •Adequate bone marrow function, defined as:
- •Absolute neutrophil count (ANC) ≥1.500/mm3 or ≥1.5x109/L; Hemoglobin ≥ 9 g/dL. Platelet count ≥ 100.000/mm
- •Adequate renal function, defined as: Creatinine clearance ≥ 40 ml/min, according to MDRD formula. Urine dipstick proteinuria <2+. If urine dipstick for proteinuria ≥2+ 24 hours urine must be collected within 24 hours, and proteins must be less than 1 g.
- •Fertile males must use an effective contraceptive method (error rate per year <1%) during the trial and until 6 months after the last study treatment dose, such as sexual abstinence, previous vasectomy and/or having a partner using any of following methods: implantables, injections, combined oral contraceptives and/or intrauterine device (hormonal only).
排除标准
- •Previous chemotherapy for advanced NSCLC.
- •History of haemoptysis grade ≥ 2 (defined as at least 2.5 mL of bright red blood) in the 3 months before inclusion.
- •Major surgery (including open biopsy), significant traumatic injuries in the 28 days before inclusion or anticipation of the need of major surgical procedure during the treatment period
- •Minor surgery, including permanent catheter insertion, in the 24 hours before bevacizumab infusion.
- •Untreated brain metastases. Patients with CNS metastases treated with radiotherapy or surgery may be included if there is no evidence of progression after treatment
- •Radiological evidence of a tumor that invades or is adjacent to a main blood vessel (e.g. lung artery or superior cava venous).
- •Radiotherapy, in any lesion and for any reason, within 28 days before inclusion. Palliative radiotherapy for bone lesions within 14 days before inclusion is allowed.
- •Treatment with aspirin (>325 mg/day) or clopidogrel (>75 mg/day) within 10 days prior to bevacizumab first dose. Use of full dose of oral or parenteral anticoagulants or thrombolytic agents in therapeutic doses. Prophylactic use of anticoagulant therapy is allowed.
- •Uncontrolled hypertension (systolic BP >140 mmHg, diastolic BP >90mmHg) in the 28 days previous to inclusion or history of hypertensive crisis , or hypertensive encephalopathy.
- •Clinically significant cardiovascular disease (i.e. cerebrovascular accident (CVA), myocardial infarction within 6 months prior to inclusion, unstable angina, congestive cardiac insufficiency NYHA ≥ II, left ventricular ejection fraction (LVEF) <50% or serious cardiac arrhythmia), not responding to treatment or that can interfere with trial treatment administration.
- •Not healed wounds, active peptic ulcer or untreated bone fracture.
- •Hypersensibility to any of the active ingredients of the study treatment (bevacizumab, carboplatine and paclitaxel) or any of its excipients.
- •Serious cognitive impairment that limits the patient to understand and answer the study questionnaires.
- •Inability to comply with the study protocol and/or follow-up procedures due to psychological, familiar, social or geographical problems
- •Patients with an ADL score <5 at the screening.
- •Patients with dementia: 9-12 points in the Folstein MMS at the screening.
- •Patients accomplishing fragility Balducci criteria at the screening:
- •Age ≥ 85 years old Dependence in 1 or more ADL >3 comorbidities >1 geriatric syndrome
结局指标
主要结局
Rate of grade 3-4 neutropenia defined according to National Cancer Institute Common Terminology Criteria version 4.0 (NCI-CTC v4.0)
时间窗: participants will be followed for the duration of the study, around 3 years
次要结局
- Plasma VEGF(participants will be followed for the duration of the study, around 3 years)
- progression-free survival and overall survival(participants will be followed for the duration of the study, around 3 years)
- Objective response and Stable disease according to RECIST(participants will be followed for the duration of the study, around 3 years)