NCT00717990终止2 期
A Phase II Study of Irinotecan, Capecitabine and Avastin in Patients With Metastatic Colorectal Cancer, Who Have Progressed After 1ST Line Therapy With Folfox/Avastin.
University Hospital of Crete1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This study will evaluate the efficacy of Irinotecan,Capecitabine and Avastin combination in patients with no response to previous treatment with 5-Fluorouracil,Leucovorin,Eloxatin and Avastin.
详细描述
The aim of this phase II study is to evaluate the efficacy of the combination XELIRI/AVASTIN in patients with mCRC, who have progressed in first line treatment with FOLFOX/AVASTIN. For AVASTIN was selected the dosing schedule of the trials TREE 1 and 2 [17], where Avastin was combined with capecitabine and oxaliplatin in a three weeks schedule and with adaptation of the dose in the 7,5 mg/kg
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 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed locally advanced or metastatic colorectal cancer
- •Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors
- •ECOG performance status ≤ 2
- •Age 18 - 72 years
- •Patients who progress after 1st line therapy with FOLFOX/AVASTIN
- •Adequate liver (Bilirubin ≤ 1.5 upper normal limit, SGOT/SGPT ≤ 4 upper normal limit, ALP ≤ 2.5 upper normal limit) renal (Creatinine ≤ 1.5 upper normal limit) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function
- •Patients must be able to understand the nature of this study
- •Written informed consent
排除标准
- •History of serious cardiac disease (unstable angina, congestive heart failure,uncontrolled cardiac arrhythmias)
- •History of myocardial infarction or stroke within 6 months
- •Clinically significant peripheral vascular disease
- •History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day 0
- •Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Day 1
- •Presence of central nervous system or brain metastasis
- •Evidence of bleeding diathesis or coagulopathy
- •Blood pressure > 150/100 mmHg
- •Pregnant or lactating woman
- •Life expectancy < 3 months
- •Previous radiotherapy within the last 4 weeks or > 25% of bone marrow
- •Metastatic infiltration of the liver > 50%
- •Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy
- •Active infection requiring antibiotics on Day 1
- •Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
- •Psychiatric illness or social situation that would preclude study compliance
研究组 & 干预措施
1
Experimental
XELIRI/Avastin
干预措施: Irinotecan (Drug)
1
Experimental
XELIRI/Avastin
干预措施: Capecitabine (Drug)
1
Experimental
XELIRI/Avastin
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: up to 6 months
次要结局
- Toxicity profile(Toxicity assessment on each chemotherapy)
- Symptoms improvement(Assessment every two cycles)
- Time To Progression(1 year)
- Overall Survival(1 year)
- Quality of life(Assessment every two cycles)
研究者
Vassilis Georgoulias, MD
MD
University Hospital of Crete
研究点 (1)
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