NCT00049790已完成2 期
Safety and Efficacy Study of rhAngiostatin Administered in Combination With Paclitaxel and Carboplatin to Patients With Non-Small-Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of rhAngiostatin protein administered in combination with paclitaxel and carboplatin to patients with non-small-cell lung cancer.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Histological or cytological confirmed Stage IIIB NSCLC with malignant pleural effusions, or Stage IV NSCLC or recurrent NSCLC
- •No previous chemotherapy for NSCLC
- •Have one lesion that is bidimensionally measurable by physical exam, MRI, or CT greater than 1 cm in diameter
- •Specified lab parameters
- •Life expectancy of at least 12 weeks
- •ECOG performance status of 0 or 1
- •Understand requirements of study
- •Agree to use effective contraceptive methods
排除标准
- •Have CNS metastases
- •Have any active cancer in addition ot NSCLC
- •Participated in clinical trial involving conventional or investigational drugs within previous 4 weeks
- •Have any contraindication to paclitaxel or carboplatin
- •Have had Grade 3 or greater peripheral neuropathies
- •Be pregnant or lactating
- •Have a history of myocardial infarction or angina pectoris/angina in the last 6 months
- •Have had significant (30 mL or more) hemoptysis with the past 3 months
- •Have an active infection
- •Have a history of bleeding diathesis, hypercoagulable condition, or an active bleeding disorder
- •Be receiving concurrent treatment with therapeutic doses of heparin or coumadin
- •Have had major surgery within 4 weeks of stating therapy
- •Have additional uncontrolled serious medical conditions or psychiatric illness
- •Received rhAngiostatin in other clinical protocols
研究者
研究点 (1)
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