Open-label, Efficacy and Safety Study of Bevacizumab (Avastin®) in Combination With XELOX (Oxaliplatin Plus Xeloda®) for the First-line Treatment of Patients With Metastatic Cancer of the Colon or Rectum - 'OBELIX'
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 205
- 主要终点
- Progression-Free Survival (PFS): Percentage of Participants With Progressive Disease or Death
研究概览
简要总结
This single arm study will evaluate the efficacy and safety of a first-line regimen of Avastin and XELOX (oxaliplatin + Xeloda) in patients with metastatic cancer of the colon or rectum. Patients will receive 21-day cycles of treatment, comprising Avastin 7.5mg/kg iv on day 1, oxaliplatin 130mg/m2 iv on day 1, and Xeloda 1000mg/m2 po twice daily on days 1-14, for a maximum of 6 months. Patients with stable disease or complete or partial response may continue on Avastin therapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >=18 years of age;
- •locally advanced or metastatic colorectal cancer;
- •no previous treatment with chemotherapy for metastatic disease;
- •at least one measurable lesion.
排除标准
- •radiotherapy to any site within 4 weeks before study;
- •untreated brain metastases or primary brain tumors;
- •clinically significant cardiovascular disease;
- •chronic daily treatment with high dose aspirin (>325 mg/day);
- •other co-existing malignancies or malignancies diagnosed within last 5 years.
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: Oxaliplatin (Drug)
1
干预措施: Xeloda (Drug)
结局指标
主要结局
Progression-Free Survival (PFS): Percentage of Participants With Progressive Disease or Death
时间窗: Baseline and Day 1 of every cycle until disease progression or death up to 5 years
PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented neither a relapse nor a new colorectal cancer had occurred. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
PFS: Time to Event
时间窗: Baseline and Day 1 of every cycle until disease progression or death up to 5 years
PFS was defined as the time period in months from the start of study treatment to the first observation of disease progression or death from any cause, whichever occurred first. Data for participants with no tumor assessments after baseline but who were still alive at the time of the clinical cutoff were censored at Day 1. Participants who underwent surgery after experiencing a sufficient shrinkage of the tumor, had any relapse, new occurrence of colorectal cancer, or who died were all considered as having had an event. Participants who underwent surgery without any such event were censored at the date of the last tumor assessment that documented that neither a relapse nor a new colorectal cancer had occurred. Median PFS was estimated using the Kaplan-Meier method.
次要结局
- Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Among Participants in the ITT Population Who Had at Least 1 Post-Baseline Assessment(Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years)
- Percentage of Participants With a CR or PR Among Participants in the ITT Population(Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years)
- Time to CR or PR Overall Response - Time to Event(Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years)
- Percentage of Participants With a Best Overall Response of CR or PR During First Line Treatment(Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years)
- Duration of Overall Response Among Participants Whose Best Response Was CR or PR During First Line Treatment - Time to Event(Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years)
- Percentage of Participants With a Stable Response During First Line Treatment(Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years)
- Duration of Stable Response(Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years)
- Percentage of Participants With Treatment Failure(Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years)
- Time to Treatment Failure(Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years)
- Overall Survival: Percentage of Participants That Died Due to Any Cause(Baseline, Day 1 of every cycle to end-of-treatment, every 3 months during longer-term follow-up, or to death due to any cause up to 5 years)
- Overall Survival: Time to Event(Baseline, Day 1 of every cycle to end-of-treatment, every 3 months during longer-term follow-up, or to death due to any cause up to 5 years)
- Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery(At surgery, at least 6 to 8 weeks after last dose of bevacizumab up to 5 years)
- Percentage of Participants With Best Overall Response of CR or PR by Kirsten Rat Sarcoma Viral Oncogene Homolog (K-Ras)/V-Raf Murine Sarcoma Viral Oncogene Homolog B (B-Raf) Mutation Status(Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years)
- European Quality of Life 5 Dimension (EQ-5D) Raw-Index Score(Baseline, every 9 weeks (every 3 cycles), at end-of-treatment up to 5 years)