Bevacizumab, Docetaxel, and Gemcitabine Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
A Phase II Study of Bevacizumab Plus Docetaxel and Gemcitabine in Subjects With Advanced, Previously Untreated, Non-Squamous Non-Small Cell Lung Cancer
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel and gemcitabine hydrochloride may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and gemcitabine hydrochloride works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
研究概览
详细说明
OBJECTIVES:
Primary
- Estimate the 1-year progression-free survival rate in patients with stage IIIB, stage IV, or recurrent non-squamous cell non-small cell lung cancer treated with bevacizumab, docetaxel, and gemcitabine hydrochloride.
Secondary
- Evaluate the median time to progression in patients treated with this regimen.
- Estimate the response rate in patients treated with this regimen.
- Determine the median overall survival of patients treated with this regimen.
- Determine the incidence of adverse events associated with this regimen in these patients.
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes and docetaxel IV over 60 minutes on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease may then continue to receive bevacizumab alone for up to 12 months in the absence of disease progression.
After completion of study treatment, patients are followed up every 3 months.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
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Cleveland、Ohio、美国、44106
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
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Cleveland、Ohio、美国、44111
- Fairview Hospital, Moll Pavilion
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Mayfield Heights、Ohio、美国、44124
- Hillcrest Hospital, a Cleveland Clinic Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically confirmed non-squamous cell non-small cell lung cancer
- Stage IIIB (with pleural effusion), stage IV, or recurrent disease
- Bidimensionally measurable disease
No known CNS disease, except for previously treated brain metastasis defined as no evidence of progression or hemorrhage after treatment AND no ongoing requirement for dexamethasone as documented by clinical examination, MRI, or CT scan
- Treatment for brain metastases may have included whole brain radiotherapy, radiosurgery (gamma knife, LINAC, or equivalent), or a combination of therapy as deemed appropriate by the treating physician
- Stable dose of anticonvulsants allowed
- No known metastatic disease to the gastrointestinal tract (e.g., stomach, small bowel, or large bowel)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy > 3 months
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Bilirubin ≤ 2.0 mg/dL
- AST or ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5.0 times ULN if hepatic metastases are present)
- Serum creatinine ≤ 1.8 mg/dL
- Urine protein:creatinine ratio < 1.0 OR proteinuria < 2+ by urine dipstick OR ≤ 1 g of protein by 24-hour urine collection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Available for regular follow-ups
- No inadequately controlled hypertension, defined as systolic BP > 150 mm Hg and/or diastolic BP > 100 mm Hg despite antihypertensive medications
- No history of hypertensive crisis or hypertensive encephalopathy
- No NYHA class II-IV congestive heart failure
- No myocardial infarction or unstable angina within the past 6 months
- No stroke or transient ischemic attack within the past 6 months
- No significant vascular disease (e.g., aortic aneurysm, aortic dissection requiring surgical repair, or recent peripheral arterial thrombosis) within the past 6 months
- No symptomatic peripheral vascular disease
- No evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
- No history of colonic diverticular disease (i.e., diverticulosis or diverticulitis)
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No serious, nonhealing wound, ulcer, or bone fracture
- No known hypersensitivity to any component of bevacizumab
- No hemoptysis (bright red blood of ≥ ½ teaspoon per episode) within the past 3 months
- No significant traumatic injury within the past 28 days
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or biological therapy
- No prior radiotherapy to an area of measurable disease unless there is documented progressive disease after completion of therapy
- More than 2 weeks since prior radiotherapy
- More than 4 weeks since prior and no concurrent participation in another experimental drug study, except for a Genentech-sponsored bevacizumab cancer study
- More than 28 days since prior major surgical procedure or open biopsy
- More than 3 months since prior abdominal surgery
- More than 3 months since prior neurosurgical resection or brain biopsy
- More than 7 days since prior core biopsy or other minor surgical procedure, except placement of a vascular access device
- No concurrent major surgical procedure
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Bevacizumab, Docetaxel, and Gemcitabine
Treatment repeats every 21 days for up to 6 courses.
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15 mg/kg on day 1 of a 21-day cycle
75 mg/m2 on day 1
900 mg/m2 on days 1, and 8,
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Progression Free Survival(PFS)
大体时间:1 year
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PFS is defined as time to death or first occurrence of documented disease progression assessed by the investigator as per the RECIST guidelines (at lease a 20% increase in the diameter of a lesion, in addition to an absolute increase of 5mm).
If no deaths occur prior to progression, this measure will be the same as the median time to progression.
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1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Median Time to Progression
大体时间:1 year
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Time to progression (TTP) is defined as the time from start of treatment to first evidence of disease progression, defined per the RECIST 1.1 criteria as at least a 20% increase in the diameter of a lesion and an absolute increase of at least 5mm.
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1 year
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Best Response
大体时间:1 year
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The number of patients with a response will be assessed using the RECIST criteria of complete response (the disappearance of all target lesions); partial response (at least a 30% decrease in the diameter of lesions); progressive disease at least a 20% increase in the diameter of lesions); or stable disease(neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease)
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1 year
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合作者和调查者
调查人员
- 首席研究员:Nathan Pennell, MD, PhD、Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CASE4507 (其他标识符:Case Comprehensive Cancer Center)
- P30CA043703 (美国 NIH 拨款/合同)
- CASE 4507-CC694 (其他标识符:Cancer Center IRB)
- NCI-2010-00547 (其他标识符:NCI/CTRP)
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