临床试验/NCT01963351

NCT01963351已完成不适用

Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer

University of Athens1 个研究点分布在 1 个国家目标入组 150 人开始时间: 2012年1月最近更新: 2014年12月8日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 150
试验地点: 1
主要终点: Number of adverse events during 24 months of follow-up

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This observational trial is designed to assess the safety profile and tolerability of bevacizumab when combined with chemotherapy as first-line treatment of advanced or recurrent non-squamous NSCLC.

详细描述

It is an observational study for the safety and tolerability of the combination of bevacizumab with chemotherapy in locally advanced or metastatic and recurrent non-squamous non-small cell lung cancer. We try to evaluate the safety of bevacizumab in real life population with lung cancer. For patients with performance status 0-1 platinum based chemotherapy was recommended and acceptable doses of bevacizumab was either 7.5 or 15 mg/kgr. Safety profile was evaluated with Common Toxicity criteria v 3.0. Especially for bevacizumab we evaluate specific situations as thrombotic or hemorrhagic events, hypertension, albuminuria, and gastrointestinal disorders.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Written informed consent
•Age ≥18 years
•Able to comply with the protocol
•Histologically or cytologically documented, locally advanced, metastatic (Stage IV) or recurrent non-squamous NSCLC 5.ECOG PS: 0-2
•Life expectancy ≥12 weeks
•Adequate haematological function:
•Absolute neutrophil count (ANC) ≥1.5 x 109/L AND
•Platelet count ≥100 x 109/L AND
•Haemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level)
•Adequate liver function:
•Total bilirubin <1.5 x upper limit of normal (ULN) AND
•Asparagine aminotransferase (AST), alanine aminotransferase (ALT) <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases
•Adequate renal function: calculated creatinine clearance ≥50 mL/min AND
•Urine dipstick for proteinuria <2+.
•INR ≤1.5 and partial prothrombin time (PTT or aPTT) ≤1.5 x ULN within 7 days prior to enrolment
•If female, should not be pregnant or breast-feeding. Women with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 28 days prior to enrolment into the study

排除标准

•Mixed, predominant squamous component
•History of haemoptysis, in the 3 months prior to enrolment
•Evidence of tumour invading major blood vessels
•Evidence of CNS metastases, even if previously treated. If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases
•Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment
•Radical radiotherapy with curative intent within 28 days prior to enrolment. Palliative radiotherapy f is allowed
•Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment
•Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
•Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (> 325mg/day)
•Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed
•History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
•Uncontrolled hypertension
•Clinically significant (i.e. active) cardiovascular disease
•Non-healing wound, active peptic ulcer or bone fracture
•History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
•Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective, means of contraception Men who do not agree to use effective contraception during the study
•Known hypersensitivity to bevacizumab or any of its excipients, and any of the chemotherapies
•Evidence of ongoing or active infection, any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
•Patients diagnosed with a tracheo-esophageal fistula
•Prior chemotherapy or treatment with another systemic anti-cancer agent
•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
•History of thrombotic disorders within the last 6 months prior to enrollment.

结局指标

主要结局

Number of adverse events during 24 months of follow-up

时间窗: 24 months

次要结局

Overall survival(24 months)

研究者

发起方

University of Athens

申办方类型

Other

责任方

Principal Investigator

主要研究者

Kostas N Syrigos

Professor in Medical Oncology

University of Athens

研究点 (1)

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