A Phase II Trial Of Bevacizumab (NSC#704865) Plus Gemcitabine In Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Objective response rate (complete or partial responses)
研究概览
简要总结
This phase II trial is to see if combining gemcitabine with bevacizumab works in treating patients who have advanced pancreatic cancer. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. 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. Combining chemotherapy with a monoclonal antibody may kill more tumor cells
详细描述
PRIMARY OBJECTIVES:
I. To determine the objective response rate of patients with advanced pancreatic cancer who are treated with gemcitabine plus bevacizumab.
II. To determine the toxicity experienced by patients with advanced pancreatic cancer who are treated with gemcitabine plus bevacizumab.
III. To determine median and overall survival of patients with advanced pancreatic cancer who are treated with gemcitabine plus bevacizumab.
SECONDARY OBJECTIVES:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed pancreatic adenocarcinoma
- •Not amenable to curative treatment with surgery or radiotherapy
- •Locally advanced disease must extend outside the boundaries of a standard radiation port
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •Pleural effusions and ascites not considered measurable lesions
- •No obvious tumor involvement of major vessels on CT scan
- •No known brain metastases
- •Performance status - ECOG 0-2
- •More than 3 months
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •No prior bleeding diathesis
- •Bilirubin normal
- •AST/ALT no greater than 2.5 times upper limit of normal
- •PT INR no greater than 1.5
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance at least 60 mL/min
- •Urine protein less than 500 mg/24 hours if at least 1+ proteinuria
- •No significant renal impairment
- •No prior cardiovascular accident
- •No prior deep vein thrombosis
- •No myocardial ischemia or infarction within the past 6 months
- •No uncompensated coronary artery disease within the past 6 months
- •No uncontrolled hypertension
- •No symptomatic congestive heart failure
- •No cardiac arrhythmia
- •No clinically significant peripheral artery disease
- •No arterial thromboembolic event within the past 6 months, including any of the following:
- •Transient ischemic attack
- •Cerebrovascular accident
- •Unstable angina
- •Myocardial infarction
- •No prior pulmonary embolism
- •No concurrent uncontrolled illness
- •No ongoing or active infection
- •No other concurrent active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No psychiatric illness or social situation that would preclude study entry
- •No prior allergic reaction attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents (Chinese hamster ovary cell products or other recombinant human antibodies) used in this study
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior bevacizumab
- •No prior cytotoxic chemotherapy for metastatic disease
- •No prior gemcitabine
- •At least 4 weeks since prior adjuvant chemotherapy and recovered
- •At least 4 weeks since prior radiotherapy and recovered
- •No prior radiotherapy to sole site of measurable disease
- •At least 6 weeks since prior major surgery
- 另有 6 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (gemcitabine hydrochloride, bevacizumab)
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: gemcitabine hydrochloride (Drug)
Treatment (gemcitabine hydrochloride, bevacizumab)
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: bevacizumab (Biological)
Treatment (gemcitabine hydrochloride, bevacizumab)
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Objective response rate (complete or partial responses)
时间窗: Up to 2 years
次要结局
- Progression-free survival(Up to 2 years)
- Overall survival(Up to 2 years)