An Open-label Study of the Effect of First-line Treatment With Avastin+Xelox, Followed by Avastin+Tarceva, on Progression-free Survival in Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Percentage of Participants With Disease Progression or Death
研究概览
简要总结
This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day 1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1). Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every 3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •adult patients, >=18 years of age;
- •adenocarcinoma of colon or rectum, with metastatic disease;
- •>=1 measurable lesion.
排除标准
- •previous treatment with Avastin or Tarceva;
- •previous systemic treatment for advanced or metastatic disease;
- •adjuvant treatment for non-metastatic disease in past 6 months.
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: eloxatin (Drug)
1
干预措施: capecitabine [Xeloda] (Drug)
1
干预措施: erlotinib [Tarceva] (Drug)
结局指标
主要结局
Percentage of Participants With Disease Progression or Death
时间窗: Start of study to approximately 4 years
Disease progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
Progression-Free Survival
时间窗: From study start up to approximately 4 years
Progression-free survival was defined as the time from the date of informed consent until the date when the participant had progression of disease or died from disease progression. Participants who received surgical treatment after treatment ended were censored at the time of surgery. Participants who left the study for reasons other than progression of the disease were censored on the date on which they received a later antitumor therapy (with the same or different drugs, radiotherapy, or surgery).
次要结局
- Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR])(From study start up to approximately 4 years)
- Percentage of Participants Achieving Disease Control (CR, PR, or No Change [NC])(From study start up to approximately 4 years)
- Percentage of Participants Who Died(From study start up to approximately 4 years)
- Overall Survival (OS)(From study start up to approximately 4 years)