Multicenter, Open Label, Phase II Clinical Study of Gemcitabine, Capecitabine and Avastin in Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with metastatic or unresectable pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine progression-free survival of patients with metastatic or unresectable adenocarcinoma of the pancreas treated with gemcitabine, capecitabine, and bevacizumab.
Secondary
- Determine clinical response in patients treated with this regimen.
- Determine toxicity of this regimen in these patients.
- Determine quality of life of patients treated with this regimen.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the pancreas meeting 1 of the following criteria:
- •Newly diagnosed or previously treated metastatic disease
- •Unresectable disease
- •No CNS or brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute neutrophil count > 1,500/mm^3
- •WBC > 3,000/mm^3
- •Platelet count > 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed)
- •No evidence of bleeding diathesis or coagulopathy
- •Bilirubin < 2 mg/dL
- •AST or ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- •INR < 1.5 (except for patients receiving full-dose warfarin)
- •Creatinine < 1.5 mg/dL
- •No proteinuria OR
- •Urine protein < 500 mg by 24-hour urine collection
- •No clinically significant impairment of renal function
- •Cardiovascular
- •No uncontrolled hypertension (blood pressure > 160/110 mm Hg on medication)
- •No New York Heart Association class II-IV congestive heart failure
- •No unstable symptomatic arrhythmia requiring medication
- •Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed
- •No clinically significant grade II-IV peripheral vascular disease
- •No arterial thromboembolic event within the past 6 months, including any of the following:
- •Transient ischemic attack
- •Cerebrovascular accident
- •Unstable angina
- •Myocardial infarction
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other serious systemic disease
- •No significant traumatic injury within the past 28 days
- •No serious non-healing wound, ulcer, or bone fracture
- •No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •More than 28 days since prior major surgery or open biopsy
- 另有 5 项未显示
排除标准
- 未提供
结局指标
主要结局
Progression-free Survival
时间窗: every 2-4 months for 1 year and then every 6 months for 5 years
Progressive Disease is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
次要结局
- Clinical Response(Pre-treatment and every 6 weeks from treatment.)
- Percentage of Participants With Grades 3-5 Treatment Related Toxicities(Subjects were evaluated for adverse events at each study visit for the duration of their participation in the study, up to 5 years)
- Overall Survival(every 2-4 months for 1 year and then every 6 months for 5 years)
- Percentage of Participants With Improved Quality of Life(assessed at baseline then weekly for 3 weeks)