EUCTR2005-005533-35-CZ进行中（未招募）不适用
An open-label, non-controlled study of bevacizumab in combination with cisplatin-gembitabine or carboplatin-paclitaxel, as first line treatment for patients with advanced or recurrent squamous non-small cell lung cancer (NSCLC). - AVASQ
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
- 70
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
- •1. Age = 18 years.
- •2. Willing and able to comply with the protocol as judged by the
- •investigator.
- •3. ECOG Performance Status of 0 or 1.
- •4. Life expectancy of = 12 weeks at the time of inclusion.
- •5. Written informed consent obtained prior to any study specific
- •6. Histologically or cytologically documented squamous NSCLC.
- •Mixed tumours should be categorised according to the predominant
- •cell type and the squamous cells must represent 50% or more of the
- •cell components. Sputum cytology alone is not acceptable.
- •Representative samples must be sent to Roche for central review.
- •Results of the review are not required prior to inclusion and treatment
- •of the patient.
- •7. Stage IIIB with malignant pleural or pericardial effusion (i.e. patients
- •who are not candidates for radical combined modality therapy or high-dose consolidation radiotherapy) OR stage IV (metastatic) OR
- •recurrent disease.
- •8. Patients who are candidates for treatment with platinum-based
- •chemotherapy as first line chemotherapy for their disease.
- •9. Patients in whom delaying the start of platinum-based chemotherapy
- •by 3 weeks is acceptable in order to allow the administration of
- •thoracic radiotherapy to lesions at risk of haemorrhage, when treated
- •with bevacizumab. This criterion is applicable to the study population
- •10.Measurable or evaluable disease. Baseline chest CT scans and any
- •other chest imaging used for the assessment of lung lesions must be
- •sent to Roche for central review. Results of the review do not have to
- •be awaited for inclusion and treatment of the patients.
- •11. Bronchoscopic assessment available at time of inclusion into the
- •study to map and characterise endobronchial disease. Bronchoscopy
- •to be performed within 2 months prior to inclusion into the study.
- •12.Adequate renal function
- •- Serum creatinine = 1.25 x ULN or calculated creatinine
- •clearance = 50 mL/min
- •- Urine dipstick of proteinuria <2+. Patients discovered to have
- •= 2+ proteinuria on dipstick urinalysis at baseline, should
- •undergo a 24-hour urine collection and must demonstrate = 1 g
- •of protein/24 hr.
- •13.Adequate haematological function:
- •- Absolute neutrophil count (ANC) = 1.5 x 109/L
- •- Platelet count = 100 x 109/L
- •- Haemoglobin = 9 g/dL (may be transfused to maintain or exceed
- •this level)
- •- Prothrombin International Normalized Ratio (PT_INR) < 1.5;
- •aPTT =1.5 x ULN.
- •14.Adequate liver function
- •- Total bilirubin < 1.5 x upper limit of normal (ULN)
- •- AST, ALT < 2.5 x ULN in patients without liver metastases; < 5
- •x ULN in patients with liver metastases.
- •15. Free of co-morbid conditions, which could affect compliance with the
- •protocol or the interpretation of results.
- •16. If female, should not be pregnant or breast-feeding. Women with an
- 另有 11 项未显示
排除标准
- •1. Mixed, non-small cell and small cell tumours or mixed
- •adenosquamous carcinomas with a predominant non-squamous
- •non-small or small cell component.
- •2. Other primary tumours within the last 5 years before inclusion, except
- •for adequately controlled limited basal cell, squamous carcinoma of
- •the skin or carcinoma in situ of the cervix.
- •3. Prior systemic anti-tumour therapy (chemotherapy, monoclonal
- •antibody therapy or tyrosine kinase inhibitors).
- •4. Prior radiotherapy for the treatment of the patients’s current stage of
- •disease (stage IIIB with pleural or pericardial effusion, stage IV or recurrent disease). Patients who have received radiotherapy
- •to the chest as a part of the treatment of an earlier stage of disease are
- •eligible if the last fraction of radiotherapy was administered at least
- •4 weeks prior to inclusion into the study. Palliative radiotherapy for
- •the relief of metastatic bone pain allowed prior to inclusion
- •into the study, providing
- •- No more than 30% of marrow-bearing bone has been irradiated
- •- The last fraction of radiotherapy has been administered within
- •4 weeks prior to inclusion.
- •5. Patients at high-risk for radiation pneumonitis (high V20 values) or
- •unable to tolerate radiotherapy, as per investigator’s assessment. This
- •criterion applies to the study population only.
- •6. History of = grade 2 haemoptysis (bright red blood of at least
- •½ teaspoon) in the 3 months prior to inclusion into the study.
- •7. Evidence of tumour invading major blood vessels on imaging. The
- •investigator or the local radiologist must exclude evidence of tumor
- •that is fully contiguous with, surrounding, or extending into the lumen
- •of a major blood vessel (e.g. pulmonary artery or superior vena cava).
- •8. History or evidence of inherited bleeding diathesis or coagulopathy
- •with the risk of bleeding.
- •9. Current or recent (within 10 days of first dose of bevacizumab) use of
- •aspirin (> 325 mg/day) or other NSAID with anti-platelet activity or
- •treatment with dipyramidole, ticlopidine, clopidogrel (>75 mg/day)
- •and cilostaz.
- •10. Current or recent (within 10 days of first dose of bevacizumab) use of
- •full dose oral or parenteral anticoagulants or thrombolytic agent for
- •therapeutic (as opposed to prophylactic) purposes. At inclusion, exploratory population only.
- •11. Increased risk of gastrointestinal perforation, hypertension, wound
- •healing complications, thromboembolism or haemorrhage (for
- •thromboembolism and haemorrhage increased risk relates to risks
- •other than NSCLC).
- •12. Clinically serious (as judged by the investigator) non-healing wound,
- •peptic ulcer or bone fracture.
- •13. History of abdominal fistula, gastrointestinal perforation, or
- •intra-abdominal abscess within 6 months of inclusion.
- •14. Evidence of spinal cord compression or brain metastases. A CT or
- •MRI of the brain must be performed within 4 weeks prior to inclusion
- •into the study.
- •15.History or evidence, upon physical/neurological examination, of CNS
- •disease unrelated to cancer, unless adequately treated with standard
- •medical therapy.
- 另有 8 项未显示
研究者
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