NCT00318136已完成2 期
A Pilot Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events
研究概览
简要总结
This is an open-label, single-arm, multicenter pilot study to evaluate the safety and efficacy of carboplatin/paclitaxel+bevacizumab in subjects with locally advanced (Stage IIIb with pleural effusion/pericardial effusion), Stage IV, or recurrent squamous Non-Small Cell Lung Cancer (NSCLC) who have not received prior systemic therapy for metastatic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Signed Informed Consent Form(s)
- •At least 18 years of age
- •Advanced histologically or cytologically confirmed predominant squamous NSCLC
- •Subjects with treated brain metastases are eligible if there is no evidence of progression or hemorrhage after treatment of the brain metastasis/metastases
- •Prior treatment for CNS disease as deemed appropriate by the treating physician
- •ECOG performance status 0, 1, or 2
- •Measurable or evaluable disease
- •Use of an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to study entry and for the duration of the study (for women of childbearing potential and sexually active men)
排除标准
- •Prior chemotherapy for metastatic disease
- •Adjuvant chemotherapy or prior combined modality therapy (chemotherapy plus radiotherapy) if < 6 months has elapsed from completion of treatment to Day 1, Cycle 1
- •Extrathoracic metastases as the only sites of disease
- •Active malignancy other than lung cancer
- •Current, recent, or planned participation in another experimental drug study
- •Untreated brain metastases
- •Presence of intrathoracic lesion(s) with any cavitation
- •Gross hemoptysis within 3 months prior to Day 1
- •In the opinion of the investigator or local radiologist, evidence of tumor that is extending into the lumen of a major blood vessel
- •Inadequately controlled hypertension
- •Unstable angina or NYHA Grade II or greater CHF
- •Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
- •Myocardial infarction within 6 months prior to Day 1, Cycle 1
- •Stroke within 6 months prior to Day 1, Cycle 1
- •Active symptomatic peripheral vascular disease within 6 months prior to Day 1, Cycle 1
- •History of significant vascular disease
- •Evidence of bleeding diathesis or coagulopathy
- •Current, ongoing treatment with full-dose warfarin or its equivalent
- •Current or recent use of aspirin (>325 mg/day)
- •Known hypersensitivity to any components of bevacizumab
- •Serious, non-healing wound, ulcer, or bone fracture
- •UPC ratio ≥ 1.0
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, Cycle 1, or anticipation of need for major surgical procedure during the course of the study
- •Pregnancy or lactation
- •Inadequate organ function
- •Any other medical conditions (including mental illness or substance abuse) deemed by the clinician to be likely to interfere with a subject's ability to provide informed consent, cooperate, or participate in the study, or to interfere with the interpretation of the results
研究组 & 干预措施
Treated with Bevacizumab
Experimental
干预措施: Bevacizumab (Drug)
Treated with Bevacizumab
Experimental
干预措施: Carboplatin (Drug)
Treated with Bevacizumab
Experimental
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events
时间窗: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death
To estimate the rate of National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE), Version 3.0, Grade ≥3 pulmonary hemorrhage adverse events. Per NCI CTCAE v.3: "Grade 3 = Transfusion, interventional radiology, endoscopic, or operative intervention indicated; radiation therapy (i.e., hemostasis of bleeding site); Grade 4 = Life-threatening consequences; major urgent intervention indicated; Grade 5 = Death."
次要结局
- Selected Adverse Events(First bevacizumab administration until 60 days after discontinuation of bevacizumab or death)
- Adverse Events That Led to Discontinuation of Bevacizumab(First bevacizumab administration until 60 days after discontinuation of bevacizumab or death)
- Progression-free Survival(Length of study)
研究者
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