NCT00544011Unknown2 期
Phase II Study Evaluating the Association of Bevacizumab and Chemotherapy of the Type Modified FOLFIRI 3 in Patients With Metastatic Colorectal Adenocarcinoma
Hopital Jean Minjoz2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2007年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Objective response (complete and partial) rate
研究概览
简要总结
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 irinotecan, fluorouracil, and capecitabine, 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 combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well bevacizumab given together with combination chemotherapy works in treating patients with metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the objective response (complete and partial) rate in patients with metastatic colorectal adenocarcinoma treated with bevacizumab and modified FOLFIRI 3 chemotherapy.
Secondary
- Determine progression-free and overall survival.
- Determine the tolerance to this regimen.
- Evaluate the resectability rate.
- Evaluate biological markers predictive of the efficacy of this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the colon or rectum
- •Previously untreated metastatic disease
- •Measurable disease by RECIST
- •Must not be located in a prior radiation field
- •No cerebral or meningeal metastases
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •WHO performance status 0-1
- •Life expectancy > 12 weeks
- •Absolute neutrophil count ≥ 1,000/mm³
- •Platelet count ≥ 100,000/mm³
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Transaminases ≤ 2 times ULN (5 times ULN if liver metastases present)
- •Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases present)
- •Creatinine ≤ 130 μmol/L OR creatinine clearance ≥ 30 mL/min
- •Proteinuria < 2+ or urine protein ≤ 1 g/24 hours
- •Not pregnant or nursing
- •Fertile patients of must use effective contraception
排除标准
- •Uncontrolled cardiac disease
- •Prior cerebral vascular accident
- •Uncontrolled arterial hypertension
- •Severe renal or hepatic insufficiency
- •Prior arteriopathy
- •Bleeding disorder or nonhealing wound
- •Coagulopathy
- •Other malignancy within the past 2 years except basal cell or squamous cell skin cancer or curatively treated carcinoma of the cervix
- •Psychiatric disorder compromising comprehension or participation in the study
- •Intestinal occlusion or subocclusion not caused by medical therapy
- •PRIOR CONCURRENT THERAPY:
- •Inclusion criteria:
- •See Disease Characteristics
- •Exclusion criteria:
- •Prior adjuvant bevacizumab or irinotecan hydrochloride
- •Concurrent aspirin (> 325 mg/day) or therapeutic anticoagulants
- •Surgery in the past 28 days
结局指标
主要结局
Objective response (complete and partial) rate
次要结局
- Resectability rate
- Biomarkers predictive of efficacy
- Progression-free survival
- Overall survival
- Tolerance
研究者
研究点 (2)
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