NCT00052390已完成2 期
A Multi-Institutional, Open-Label, Phase II Study Of Doxorubicin And Bevacizumab (Anti-VEFG Monoclonal Antibody, NSC 704865) For Patients With Advanced Or Metastatic Soft-Tissue Sarcoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 3
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Combining doxorubicin with bevacizumab may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin with bevacizumab in treating patients who have locally recurrent or metastatic soft tissue sarcoma.
详细描述
OBJECTIVES:
- Determine the response rate (partial and complete) in patients with locally recurrent or metastatic soft tissue sarcoma treated with doxorubicin and bevacizumab.
- Determine the tolerability of this regimen in these patients.
- Determine the toxicity profile of this regimen in these patients.
- Determine whether pre-treatment plasma vascular endothelial growth factor level or microvessel density of tumor samples from these patients predicts response to this regimen.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin IV over 5-10 minutes followed by bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with responding disease after reaching the maximum dose of doxorubicin may continue bevacizumab alone.
Patients are followed every 3 months for 1 year.
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 soft tissue sarcoma
- •Locally recurrent or metastatic disease
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •No prior or concurrent known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 80-100% OR
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •No bleeding diathesis or coagulopathy
- •Bilirubin no greater than 1.2 mg/dL
- •AST and ALT no greater than 2.5 times upper limit of normal
- •PT and aPTT normal
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •No proteinuria (must be less than 500 mg protein per 24 hours)
- •Cardiovascular
- •Cardiac ejection fraction at least 50% by echocardiogram or MUGA
- •No history of deep vein thrombosis
- •No clinically significant cardiovascular disease
- •No uncontrolled hypertension
- •No myocardial infarction
- •No unstable angina
- •No New York Heart Association grade II-IV congestive heart failure
- •No serious cardiac arrhythmia requiring medication
- •No grade II or greater peripheral vascular disease within the past year
- •No history of pulmonary embolism
- •No symptomatic peripheral neuropathy grade 2 or greater
- •No other neoplastic disease within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
- •No prior allergic reactions attributed to compounds of similar chemical or biological composition to bevacizumab (including products derived from Chinese hamster ovary cells), doxorubicin, or dexrazoxane
- •No HIV-positive patients receiving combination antiretroviral therapy
- •No ongoing or active infection
- •No psychiatric illness or social situations that would preclude study entry
- •No other uncontrolled concurrent illness
- •No serious, non-healing wound ulcer or bone fracture
- •No significant traumatic injury within the past 3 weeks
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •See Chemotherapy
- •At least 4 weeks since prior immunotherapy and recovered
- •No other concurrent immunotherapy
- 另有 20 项未显示
排除标准
- 未提供
研究者
研究点 (3)
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