Phase II Study of Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Malignant Mesothelioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 6
- 主要终点
- To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma
研究概览
简要总结
The purpose of this study is to determine whether the combination of the investigational drugs Avastin and Tarceva are effective in patients with mesothelioma who have previously been treated with chemotherapy.
详细描述
Each cycle of study treatment lasts 21 days. The patient will take erlotinib by mouth once daily. On day 1 of every cycle, the patient will receive bevacizumab intravenously over a 30-90 minute time period.
CT scan(s), MRI(s) and/or x-ray(s) of the cancer site will be performed every 6 weeks (2 cycles) to assess the extent of the response to treatment.
Bloodwork will be performed before the first dose of erlotinib and bevacizumab at Cycle 1, Cycle 2, Cycle 3, and at the end of treatment.
At the completion of the treatment a physical exam, vital signs, blood tests, urine tests and standard radiologic testing will be performed.
The duration of study depends upon how the patients' mesothelioma responds to treatment as well as how well the patient tolerates the medication.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mesothelioma that has been previously treated with at least one chemotherapy regimen
- •18 years of age or older
- •Must at least be able to walk and capable of taking care of oneself although unable to carry out work activities
- •Four or more weeks since last major surgery
- •Four or more weeks since last radiation therapy
- •Three or more weeks since last chemotherapy
- •Life expectancy of 12 weeks or more
- •Blood tests that show kidneys, liver and bone marrow to be working adequately
- •Able to comply with study and/or follow-up procedures
排除标准
- •Prior exposure to Tarceva (OSI-774, erlotinib), trastuzumab, ZD1839 or C225
- •Receiving anticoagulation medication other than low dose Coumadin
- •Clinically significant heart disease such as uncontrolled hypertension, previous heart attack within past 12 months, uneven heartbeat, etc.
- •History of central nervous system disease such as seizures not controlled with standard medical therapy, brain metastases or history of stroke
- •Major surgery within 28 days of screening
- •Daily treatment with aspirin or anti-inflammatory medications
- •Pregnant or lactating (pertaining to women only)
- •Serious or nonhealing wound, ulcer or bone fracture
- •Difficulty swallowing
- •A disease or disorder that interferes with ability to digest and absorb food
- •History of coughing up more than 1/4 teaspoon of blood
- •A medical condition that could make it unsafe for patient to participate in this study
结局指标
主要结局
To determine the response to the combination of bevacizumab and erlotinib in previously treated malignant mesothelioma
时间窗: 3 years
次要结局
- To determine the time to tumor progression
- to determine the duration of response
- to determine the median and overall survival of patients
- to determine the safety of the drugs administered(3 years)
研究者
Pasi A. Janne, MD, PhD
Associate Professor, Medicine
Dana-Farber Cancer Institute