Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 15
- 主要终点
- progression-free survival
研究概览
简要总结
Chemotherapy and bevacizumab is given for 4 months. Patients who have not progressed will continue with maintenance treatment with either bevacizumab (Avastin) alone, or bevacizumab and erlotinib (Tarceva).
详细描述
Patients with metastatic colorectal cancer will be treated with standard chemotherapy according to the investigators choice. In addition to chemotherapy, Avastin (bevacizumab) will be given during the treatment period. After the chemotherapy is finished (after 18 weeks), maintenance therapy will be given and the patients will be randomized to treatment with either with Avastin alone or Avastin in combination with Tarceva (erlotinib). Patients with progressive disease, or patients suitable to curative resection of metastases will be taken out of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adenocarcinoma of the colon or rectum.
- •Measurable disease according to RECIST criteria.
- •Expected survival more than three months.
- •Adequate bone marrow, liver and kidney function.
- •INR < 1.5 times upper limit.
- •Adequate contraception for fertile patients.
- •Signed written informed consent.
排除标准
- •Earlier chemotherapy for metastatic colorectal cancer.
- •Adjuvant treatment within 6 months.
- •Surgery or significant trauma within 28 days prior to study entry.
- •Planned radiotherapy against target lesions.
- •CNS metastases.
- •Prior malignancy within 5 years except ca in situ of cervix and basal cell carcinoma.
- •Bleeding diathesis
- •Uncontrolled hypertension.
- •Significant cardiovascular disease.
- •Treatment with anticoagulant drugs.
- •Participation in other clinical trial.
- •Pregnant or lactating.
研究组 & 干预措施
1
bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab and erlotinib as maintenance treatment until progression
干预措施: erlotinib (Tarceva) (Drug)
1
bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab and erlotinib as maintenance treatment until progression
干预措施: bevacizumab (Avastin) (Drug)
2
bevacizumab and chemotherapy (according to investigators choice) during 18 weeks, followed by bevacizumab every third week until progression
干预措施: bevacizumab (Avastin) (Drug)
结局指标
主要结局
progression-free survival
时间窗: 3 years
次要结局
- overall survival(3 years)