A Phase I/II Study Of Bevacizumab (rhuMAb VEGF) In Combination With OSI-774 For Patients With Recurrent Or Metastatic Cancer Of The Head And Neck
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Objective response rate (CR + PR) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)
研究概览
简要总结
This randomized phase I/II trial is to see if combining erlotinib with bevacizumab works better in treating patients who have recurrent or metastatic head and neck cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes needed for tumor cell growth. 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 erlotinib with bevacizumab may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose and dose-limiting toxicity of bevacizumab when administered with erlotinib in patients with recurrent or metastatic head and neck cancer.
II. Determine the objective response rate and stable disease/absence of early progression in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of bevacizumab followed by a randomized, multicenter study.
Phase I: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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 or cytologically confirmed squamous cell cancer of the head and neck
- •Recurrent or metastatic disease
- •Determined to be incurable by surgery or radiotherapy
- •Measurable disease
- •No tumor involvement encasing or too close in proximity to a major artery or vein
- •No known brain metastases
- •No prior or concurrent CNS disease
- •No primary brain tumor
- •Performance status - ECOG 0-2
- •Performance status - Karnofsky 60-100%
- •More than 12 weeks
- •No history of bleeding diathesis
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •INR less than 1.5
- •Bilirubin normal
- •AST and ALT no greater than 2.5 times upper limit of normal
- •Creatinine normal
- •Creatinine clearance at least 60 mL/min
- •No significant renal impairment
- •24-hour urinary protein less than 0.5 g required if more than trace proteinuria at baseline
- •No uncontrolled hypertension
- •No symptomatic congestive heart failure
- •No serious cardiac arrhythmia requiring medication
- •No deep venous thrombosis
- •No prior stroke
- •No New York Heart Association class II-IV heart disease
- •No grade II-IV peripheral vascular disease within the past year
- •No arterial thromboembolic event within the past 6 months, including any of the following:
- •Unstable angina pectoris
- •Myocardial infarction
- •Transient ischemic attack
- •Cerebrovascular accident
- •No clinically significant peripheral artery disease
- •No significant ophthalmologic abnormalities* including any of the following:
- •Severe dry eye syndrome
- •Keratoconjunctivitis sicca
- •Sjögren's syndrome
- •Severe exposure keratopathy
- •Disorders that might increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, neutrophilic keratitis)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior allergic reactions to compounds of similar chemical or biologic composition to bevacizumab or other study agents
- •No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- •No significant traumatic injury within the past 28 days
- •No other concurrent uncontrolled illness
- •No psychiatric illness or social situation that would preclude study compliance
- •No ongoing or active infection requiring parenteral antibiotics
- 另有 16 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm II
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on days 1-28. All subsequent courses patients receive oral erlotinib on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Arm I
Patients receive bevacizumab IV over 30-90 minutes on day 15 and oral erlotinib on days 1-28. All subsequent courses patients receive oral erlotinib on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: bevacizumab (Biological)
Arm I
Patients receive bevacizumab IV over 30-90 minutes on day 15 and oral erlotinib on days 1-28. All subsequent courses patients receive oral erlotinib on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: erlotinib hydrochloride (Drug)
Arm I
Patients receive bevacizumab IV over 30-90 minutes on day 15 and oral erlotinib on days 1-28. All subsequent courses patients receive oral erlotinib on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Arm II
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on days 1-28. All subsequent courses patients receive oral erlotinib on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: bevacizumab (Biological)
Arm II
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on days 1-28. All subsequent courses patients receive oral erlotinib on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: erlotinib hydrochloride (Drug)
结局指标
主要结局
Objective response rate (CR + PR) evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)
时间窗: Up to 6 months
Maximum tolerated dose of bevacizumab when used in combination with erlotinib hydrochloride determined by dose-limiting toxicities (Phase I)
时间窗: 28 days
Progression-free survival rate (Phase II)
时间窗: Time from the start of treatment until disease progression or death, assessed up to 7 years
Overall survival rate (Phase II)
时间窗: Up to 7 years
次要结局
未报告次要终点