NCT00354549已完成2 期
Bevacizumab and Erlotinib First-Line Therapy in Advanced Non-Squamous Non-Small-Cell Lung Cancer (Stage IIIB/IV) Followed by Platinum-Based Chemotherapy at Disease Progression. A Multicenter Phase II Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 4
- 主要终点
- Disease stabilization (DS) (complete response [CR], partial response [PR], or stable disease [SD]) as assessed by RECIST criteria after 12 weeks of treatment with bevacizumab and erlotinib hydrochloride
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with erlotinib followed by cisplatin or carboplatin and gemcitabine at disease progression may be an effective treatment for non-small cell lung cancer.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib followed by cisplatin or carboplatin and gemcitabine works in treating patients with newly diagnosed or recurrent stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Assess the efficacy of bevacizumab and erlotinib hydrochloride as initial therapy in patients with newly diagnosed or recurrent stage IIIB or IV non-squamous non-small cell lung cancer (NSCLC).
Secondary
- Assess the safety of bevacizumab and erlotinib hydrochloride as initial therapy in these patients.
- Assess the quality of life (QOL) in patients treated with bevacizumab and erlotinib hydrochloride.
- Assess the efficacy and safety of subsequent cisplatin or carboplatin in combination with gemcitabine hydrochloride in patients who have disease progression.
- Assess the QOL in patients treated with subsequent cisplatin or carboplatin in combination with gemcitabine hydrochloride at disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC)
- •Newly diagnosed or recurrent disease
- •Meets 1 of the following staging criteria:
- •Stage IIIB disease, meeting both of the following criteria:
- •Proven malignant effusion or supraclavicular node involvement (i.e., N3 supraclavicular nodes)
- •Not a candidate for curative multimodality treatment or surgery
- •Stage IV disease
- •Measurable disease, defined as ≥ 1 lesion (outside of irradiated areas) that can be measured in ≥ 1 dimension as ≥ 10 mm by spiral or multi-slice CT scan or MRI
- •Immediate chemotherapy not clinically mandatory in the judgement of the investigator
- •No intrathoracic large, centrally located tumors and/or cavitary lesions invading or abutting major blood vessels
- •No evidence of clinically active interstitial lung disease
- •Patients with chronic stable radiographic changes who are asymptomatic are eligible
- •No small cell lung cancer (SCLC), squamous NSCLC, or combined SCLC-NSCLC tumors
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-1
- •Hemoglobin ≥ 10 g/dL
- •Absolute neutrophil count ≥ 1,500/mm³
- •Thrombocyte count ≥ 100,000/mm³
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •ALT ≤ 2.5 times ULN (5 times ULN if liver metastases present)
- •Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases present)
- •Quick ≥ 70% OR INR ≤ 1.5
- •Creatinine ≤ 2.0 times ULN
- •Proteinuria ≤ 2+ by urine dipstick
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 12 months after completion of study treatment
- •Able to understand trial information given by the investigator and complete quality of life questionnaire
- •No pre-existing condition that would preclude swallowing and/or absorption of oral medication
- •No prior or concurrent malignancies, except for the following:
- •Malignancy for which the minimum relapse-free interval is ≥ 5 years
- •Nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
- •No other medical condition that would preclude study participation, including any of the following:
- •Unstable or uncompensated respiratory, cardiac, hepatic, or renal disease
- •Active infection
- •Uncontrolled diabetes mellitus
- •Hypertension ≥ 150/100 mm Hg despite treatment
- •Myocardial infarction within the past 3 months
- •History of hemorrhagic disorders
- •Non-healing wound, ulcer, or bone fracture
- •No clinical history of coagulopathy or thrombosis
- •No hemoptysis or hematemesis ≥ grade 2 (defined as bright red blood of ≥ 5 mL per episode) within the past 6 months
- •No known hypersensitivity to study drug(s) or to any other component of the study drugs
- •No significant traumatic injury within the past 28 days
- •No serious underlying medical condition that would impair the ability of the patient to participate in the trial or that would preclude use of study drugs
- •No cerebrovascular accident or other CNS bleeding within the past 6 months
- •PRIOR CONCURRENT THERAPY:
- •At least 4 weeks since prior radiotherapy and recovered
- 另有 13 项未显示
排除标准
- 未提供
结局指标
主要结局
Disease stabilization (DS) (complete response [CR], partial response [PR], or stable disease [SD]) as assessed by RECIST criteria after 12 weeks of treatment with bevacizumab and erlotinib hydrochloride
时间窗: 12 weeks
次要结局
- DS as assessed by RECIST criteria after 6 and 18 weeks of treatment with bevacizumab and erlotinib hydrochloride(6 and 18 weeks)
- Objective response (CR or PR) as assessed by RECIST criteria after 6, 12, and 18 weeks of treatment with bevacizumab and erlotinib hydrochloride(6, 12 and 18 weeks)
- Best overall response when treated with bevacizumab and erlotinib hydrochloride(Until treatment ends)
- Adverse events (AEs) when treated with bevacizumab and erlotinib hydrochloride(Until treatment ends)
- Time to progression (TTP) when treated with bevacizumab and erlotinib hydrochloride(Until treatment ends)
- Objective response (CR or PR) when treated with chemotherapy(Until treatment ends)
- Unexpected adverse drug reaction(Until treatment ends)
- QOL when treated with chemotherapy(Periodically)
- Overall survival (OS) in patients treated with bevacizumab and erlotinib hydrochloride and in patients treated with subsequent chemotherapy at disease progression(life-long)
- Time to treatment failure (TTF) when treated with bevacizumab and erlotinib hydrochloride(Until treatment ends)
- Quality of life (QOL) when treated with bevacizumab and erlotinib hydrochloride(Until treatment ends)
研究者
研究点 (4)
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