NCT00278187Unknown2 期
Phase II Open-Label Study of Volociximab (M200) in Combination With Erlotinib (Tarceva™) in Previously Treated Patients With Locally Advanced (Stage IIIb) or Metastatic (Stage IV) Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 试验地点
- 1
- 主要终点
- Proportion of patients with confirmed tumor response
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as volociximab, 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. Volociximab may also stop the growth of non-small cell lung cancer 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. Giving volociximab together with erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving volociximab together with erlotinib works in treating patients with stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the response rate in patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer treated with volociximab and erlotinib hydrochloride.
Secondary
- Evaluate the time to disease progression and duration of response in patients treated with this regimen.
- Evaluate the safety of this drug regimen in these patients.
- Evaluate the pharmacokinetics this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
- •Failed ≥ 1 prior chemotherapy regimen OR refused first-line therapy
- •Measurable disease
- •No active and untreated CNS tumor or metastasis
- •Previously treated CNS tumor(s) allowed if CT scan or MRI shows clear-cut response or resolution of the original lesion(s)
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Hemoglobin ≥ 9.0 g/dL
- •WBC ≥ 2,500/mm^3
- •Absolute neutrophil count ≥ 1,000/mm^3 (growth factor independent)
- •Platelet count ≥ 100,000/mm^3
- •Total bilirubin ≤ 1.5 mg/dL
- •AST and ALT ≤ 3 times upper limit of normal (ULN) (5 times ULN if patient has liver metastases)
- •Alkaline phosphatase ≤ 5 times ULN
- •Serum creatinine ≤ 2.0 mg/dL
- •PT/PTT normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective (double barrier or abstinence) contraception
- •No uncontrolled seizure disorder or active neurological disease
- •No thromboembolic events (i.e., stroke or deep vein thrombosis) within the past year
- •No clinically significant medical condition that would complicate compliance with study treatment or be exacerbated by bleeding, including but not limited to:
- •Known bleeding disorders, such as coagulation defects and thrombasthenias
- •Active gastric or duodenal ulcer
- •History of gastrointestinal (GI) bleeding requiring transfusion within the past year
- •History of tumor bleeding
- •History of significant hemoptysis requiring intervention (i.e., transfusion, laser therapy, surgical treatment, or radiation) within the past year
- •No known active infections requiring IV antibiotics, antivirals, or antifungals (e.g., HIV, hepatitis B, or hepatitis C infection)
- •No unstable cardiac disease, including any of the following:
- •Poorly controlled angina
- •Congestive heart failure
- •Arrhythmias
- •Myocardial infarction within the past year
- •Acute ischemia by ECG
- •Untreated significant conduction abnormality
- •Bifascicular block (defined as left anterior hemiblock in the presence of right bundle branch block)
- •Second- or third-degree atrioventricular block
- •No asthma or oxygen-dependent chronic pulmonary disease
- •No cerebrovascular event (e.g., stroke or transient ischemic attack) within the past year
- •No peripheral vascular disease requiring surgery within the past year
- •No clinically significant or unstable medical condition, including, but not limited to, any of the following:
- •Diabetes mellitus requiring insulin
- •Uncontrolled hypertension
- •Uncontrolled or symptomatic orthostatic hypertension
- •No serious psychiatric illness, active alcoholism, or drug addiction that may preclude study treatment
- •No condition that, in the investigator's opinion, would make the patient unsuitable for study treatment
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Prior immunotherapy, including monoclonal antibodies, or vaccine therapy allowed
- 另有 19 项未显示
排除标准
- 未提供
结局指标
主要结局
Proportion of patients with confirmed tumor response
次要结局
- Pharmacokinetics
- Time to disease progression
- Duration of response
- Adverse events and serious adverse events
- Immunogenicity
研究者
研究点 (1)
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