NCT01814163已完成不适用
Observational Studies to Explore the Relation Between Angiogenic Markers and the Treatment Response With Carboplatin, Paclitaxel and Bevacizumab in First Line of Advanced Non-small-cell Lung Cancer With Non- Squamous Histology
Spanish Lung Cancer Group20 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 20
- 主要终点
- Correlation between angiogenesis markers and progression free survival.
研究概览
简要总结
This is a pharmacogenomic study with carboplatin, paclitaxel and bevacizumab as first line therapy in patients with non-squamous advanced non-small cell lung cancer.
详细描述
This is a observational study prospectively followed post-authorization.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients should sign inform consent before inclusion in the study that specifies that the clinical treatment entails consent for the analysis of biological samples of tumor and blood.
- •Histologically confirmed diagnosis of advanced non small-cell lung carcinoma, non-squamous cell
- •Patients age 18 years or more
- •Patients will be candidates to received a first line of chemotherapy of carboplatin, paclitaxel and bevacizumab as the best therapeutic option.
- •Evidence of measurable disease per Response Evalutation Criteria in Solid tumors (RECIST)
- •Patients must be avalaible for clinical follow-up
- •Patients with the following hematologic/biochemical values:
- •Absolute Neutrophil Count ANC > 1500/µl.
- •Platelets > 100.000 /µl.
- •Hemoglobine > 10 g/dl.
- •Bilirrubin < 1.5 mg/dl.
- •Aspartate aminotransfereasa (AST) and Alanine transaminase (ALT) ≤ 3 x LSN, except in case of hepatic metastases: upper 5 x LSN
- •Creatinine clearance ≥ 45 ml/min.
排除标准
- •Previous treatment for advanced disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neadjuvant treatment
- •history of haemoptysis (defined as at least half a teaspoon's emission of red blood) in the 3 months prior to inclusion
- •evidence by CT of tumor cavitations, or tumours invading or abutting major blood vessels
- •Known or suspected brain metastases non-treated.
- •Major surgery within 28 days of starting treatment.
- •Minor surgery within 24 hours before starting the treatment.
- •Non-controlled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg).
- •Patients with coronary disease or uncontrolled arrhytmia, uncontrolled cerebrovascular disease and other clinical conditions that, in judgment of the investigator, contraindicate the patient's participation in the study.
- •History or evidence of bleeding diathesis or hereditary coagulopathy.
- •Contraindication or suspected allergy to the products under investigation in the study:: paclitaxel, carboplatine or bevacizumab.
- •Patients who are pregnant or breasfeeding. Women of childbearing potencial must have a negative pregnancy test performed within 7 days before the onset of treatment.
- •Substance abuse of clinical, psychological or social conditions that can undermine the validity of the informed consent or protocol compliance
研究组 & 干预措施
Paclitaxel, carboplatin and bevacizumab
Paclitaxel 200 mg/m2, carboplatin area under curve (AUC) 6 mg/ml/min plus bevacizumab 15 mg/kg on day 1, every 21 days. Total number of cycles: 6. After 6 cycles bevacizumab on monotherapy until progression
干预措施: paclitaxel, carboplatin and bevacizumab (Drug)
结局指标
主要结局
Correlation between angiogenesis markers and progression free survival.
时间窗: 1 year
次要结局
- Overal survival(3 year)
- Objective response(24 months)
- Duration of response(24 months)
- Treatment security(24 months)
- Survival at 12 and 24 months(12-24 months)
研究者
研究点 (20)
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