A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria
研究概览
简要总结
This randomized, open-label study will evaluate the safety and efficacy of Avastin (Bevacizumab) added to standard mFOLFOX6 chemotherapy in treatment-naïve patients with Stage IV metastatic colorectal cancer. According to K-RAS gene mutation status, patients will be assigned or randomized to receive either Avastin 5 mg/kg intravenously (iv) on Day 1 of each 2-week cycle or cetuximab 400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week, in addition to mFOLFOX6 every 2 weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
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
- •Adult patients >/= 18 years of age
- •Histologically confirmed adenocarcinoma of the colon or rectum
- •Stage IV metastatic disease with at least one measurable metastatic lesion according to RECIST criteria
- •Tumour tissue sample available for assessment of K-RAS and BRAF genes
- •Prior radiotherapy must have been completed 4 weeks before randomization
- •Adequate bone marrow, kidney and liver function
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
排除标准
- •Previous chemotherapy for metastatic disease
- •Completion of adjuvant treatment for colorectal cancer (Stage I, II and III) in the 12 months preceding randomization
- •Prior treatment with bevacizumab, cetuximab or other EGFR inhibitors
- •Clinical or radiographic evidence of brain metastases
- •Clinically significant cardiovascular disease or disorder
- •History of neoplastic disease other than colorectal cancer in the 3 years prior to start of study treatment, except for successfully treated non-invasive carcinomas such as cervical cancer in situ, basal cell carcinoma of the skin or superficial bladder tumours
- •HIV, hepatitis B or C infection
研究组 & 干预措施
K-RAS mutated
干预措施: bevacizumab [Avastin] (Drug)
K-RAS mutated
干预措施: mFOLFOX6 (Drug)
K-RAS native A
干预措施: bevacizumab [Avastin] (Drug)
K-RAS native A
干预措施: mFOLFOX6 (Drug)
K-RAS native B
干预措施: cetuximab (Drug)
K-RAS native B
干预措施: mFOLFOX6 (Drug)
结局指标
主要结局
Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria
时间窗: up to 4 years
次要结局
- Objective response rate(4 years)
- Safety: Incidence of adverse events(4 years)
- Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30)(up to 4 years)
- Overall survival(up to 4 years)
- Progression-free survival: comparison of the two treatment regimens in the native K-RAS arms(up to 4 years)