NCT01057017终止2 期
Panitumumab and Bevacizumab Maintenance After First-Line FOLFOX-Bevacizumab for Patients With Advanced Colorectal Cancer With Wild-Type Ras
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab
研究概览
简要总结
Bevacizumab given at 7.5mg/kg. IV over 10-90 minutes every 3 weeks until disease progression.Panitumumab given at 9mg/kg. IV over 30-90 minutes every 3 weeks until disease progression.Primary Objective: To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer.
详细描述
26 patients with advanced colorectal cancer will be given Bevacizumab at 7.5mg/kg. IV over 10-90 minutes every 3 weeks until disease progression.Panitumumab given at 9mg/kg. IV over 30-90 minutes every 3 weeks until disease progression
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 pathologically confirmed advanced colorectal cancer who received FOLFOX/bevacizumab for first-line treatment of metastatic disease.
- •Patients must not have had disease progression while receiving a minimum of 6 treatments of FOLFOX/bevacizumab. Patients with stable or responding disease on FOLFOX/bevacizumab are eligible. Bevacizumab does not need to be administered with all cycles of FOLFOX.
- •At least 3 weeks since prior FOLFOX/bevacizumab.
- •Wild type ras
- •No potentially curative treatment option.
- •ECOG performance status 0-1
- •Age>18, not pregnant or breast-feeding
- •Required entry laboratory parameters within 14 days of study entry: Granulocytes ≥ 1500/µl; platelet count ≥ 100,000/µl, Creatinine ≤ 2.0 mg/dl, Bilirubin ≤ 1.5 x upper limit of normal, AST ≤ 3 x upper limit of normal (or ≤ 5 x upper limit of normal for patients with liver metastases), Magnesium > lower limit of normal
- •Life expectancy of at least 16 weeks
- •Must not have uncontrolled severe, intercurrent illness.
- •No chemotherapy or radiation therapy within last 3 weeks
- •No concurrent anticancer therapy.
- •Signed study-specific consent form prior to study entry
排除标准
- •Prior EGFR inhibitor and prior irinotecan.
- •Clinically significant cardiac disease (e.g., uncontrolled hypertension [blood pressure of >150/90 mmHg on medication], history of myocardial infarction within 6 months,), New York Heart Association (NYHA) Class II or greater congestive heart failure within 6 months, unstable arrhythmia. Patients with an atrial arrhythmia must have this condition well controlled on stable medication. Patients with current or recent (within 6 months) unstable angina are also not eligible.
- •Significant bleeding diathesis or coagulopathy
- •Major surgical procedure within 28 days prior to start of treatment. Port-a-cath placements are allowed.
- •Serious, nonhealing wound, ulcer, or current healing fracture
- •History of cerebral aneurysms or cerebral arteriovenous malformations.
- •Patients with recent (within 12 months) arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), or clinically significant peripheral artery disease should also be excluded.
- •Brain metastases
- •Patients with a history of a gastrointestinal fistula or perforation.
- •Significant infection or other coexistent medical condition that would preclude protocol therapy.
- •Interstitial lung disease
- •Patients who have had an organ transplant
- •Known positive test(s) for HIV infection, hepatitis C virus, acute or chronic active hepatitis B infection
- •Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, bladder and cervix are permissible).
结局指标
主要结局
Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab
时间窗: every 3 weeks until patient comes off study (progressive disease), for up to 2 years
To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer. Use of CTCAE version 3
次要结局
未报告次要终点
研究者
howard safran
Director of BrUOG
Brown University
研究点 (2)
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