Phase II Study Of Bevacizumab And PEG Interferon Alpha-2b (PEG Intron) In Patients With Metastatic, Or Unresectable Carcinoid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Tumor response rate (CR + PR) as measured by RECIST criteria
研究概览
简要总结
This randomized phase II trial is to see if combining bevacizumab with PEG-interferon alfa-2b works in treating patients who have metastatic or unresectable carcinoid tumors. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. PEG-interferon alfa-2b may stop the growth of cancer by stopping blood flow to the tumor. Combining bevacizumab with PEG-interferon alfa-2b may kill more cancer cells
详细描述
OBJECTIVES:
I. Determine the progression-free survival rate in patients with metastatic or unresectable carcinoid tumors treated with bevacizumab and PEG-interferon alfa-2b.
II. Determine the tumor response rate (complete and partial) in patients treated with this regimen.
III. Determine the biochemical response rate of patients treated with this regimen.
IV. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed carcinoid tumor
- •Metastatic or unresectable local-regional disease
- •Measurable disease
- •No osseous metastasis as the only site of disease
- •No history or clinical evidence of CNS disease (e.g., primary brain tumor or any brain metastasis)
- •Performance status - Zubrod 0-2
- •Performance status - Karnofsky 70-100%
- •At least 12 weeks
- •See Immunologic
- •Absolute granulocyte count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Hemoglobin > 8 g/dL
- •No bleeding diathesis or coagulopathy
- •No hemoglobinopathies (e.g., thalassemia) or any other cause of hemolytic anemia
- •Bilirubin < 1.5 mg/dL
- •INR < 1.5 (if receiving warfarin)
- •No evidence of decompensated liver disease (e.g., ascites, bleeding varices, or spontaneous encephalopathy)
- •Creatinine < 1.5 mg/dL
- •No baseline proteinuria
- •Patients with proteinuria (≥ 2+ or ≥ 100 mg/dL on urinalysis) are allowed provided 24-hour urinary protein is < 500 mg
- •No New York Heart Association grade II-IV congestive heart failure
- •No serious cardiac arrhythmia requiring medication
- •No clinically significant peripheral vascular disease
- •No history of stroke
- •None of the following within the past 6 months:
- •Uncontrolled hypertension
- •Transient ischemic attack
- •Cerebrovascular accident
- •Unstable angina
- •Myocardial infarction
- •No chronic pulmonary disease (e.g., chronic obstructive pulmonary disease)
- •No documented pulmonary hypertension
- •None of the following immunologically mediated diseases:
- •Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
- •Rheumatoid arthritis
- •Idiopathic thrombocytopenia purpura
- •Systemic lupus erythematosus
- •Autoimmune hemolytic anemia
- •Scleroderma
- •Severe psoriasis
- •No serious concurrent infections
- •No active infection requiring parental antibiotics on day 0
- •No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- •No known hypersensitivity to interferon alfa or to any excipient or vehicle included in its formulation or delivery system
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No significant traumatic injury within the past 4 weeks
- •No preexisting thyroid abnormality for which thyroid function can not be normalized by medication
- •No concurrent nonmalignant uncontrolled medical illness or one whose control may be jeopardized by the complications of this study therapy
- 另有 17 项未显示
排除标准
- 未提供
结局指标
主要结局
Tumor response rate (CR + PR) as measured by RECIST criteria
时间窗: Up to 4 years
次要结局
- Progression free survival(From the time of initial treatment to the time of PD or death, assessed up to 4 years)
- Biochemical response rate measured after treatment(Up to 4 years)
- Toxicity graded according to CTC v3.0 criteria for adverse outcomes(Up to 4 years)