A Randomised, Open-label Phase III Study to Assess Efficacy and Safety of Bevacizumab in Combination With Capecitabine as First-line Treatment for Elderly Patients With Metastatic Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 280
- 主要终点
- Progression-free Survival
研究概览
简要总结
This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5 mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) alone.
No notable trends or interactions in laboratory values, electrocardiogram, or vital signs suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or capecitabine monotherapy were observed during the 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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, ≥ 70 years of age.
- •Cancer of the colon or rectum.
- •Metastatic disease diagnosed ≤ 6 months before enrollment.
- •≥ 1 measurable metastatic lesion.
排除标准
- •Adjuvant anti-vascular endothelial growth factor (VEGF) treatment.
- •Prior chemotherapeutic treatment for metastatic colorectal cancer.
- •Past or current history of other malignancies (with the exception of basal and squamous cell cancer of the skin, or in situ cancer of the cervix).
- •Clinically significant cardiovascular disease.
- •Current or recent daily use of aspirin (> 325 mg/day) or other non-steroidal anti-inflammatory drug (NSAID), or full dose anticoagulants.
研究组 & 干预措施
Bevacizumab + capecitabine
Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
干预措施: Bevacizumab (Drug)
Bevacizumab + capecitabine
Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
干预措施: Capecitabine (Drug)
Capecitabine
Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: Baseline to the end of the study (up to 5 years 8 months)
Progression-free survival was defined as the time in months from the date of randomization to the date of disease progression or death from any cause, whichever occurred first. All measurable lesions (maximum of 5 per organ and 10 in total, those with the longest diameter and suitability for accurate repeated measurements) were identified as target lesions (TL). A sum of the longest diameter for all TLs was calculated and reported as the baseline sum longest diameter (SLD). All other lesions were identified as non-TLs and recorded at baseline. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.
次要结局
- AEs, Laboratory Parameters, Vital Signs(Throughout study)
- Percentage of Participants Requiring Additional Treatment for Malignancy(Baseline to the end of the study (up to 5 years 8 months))
- Duration of Response(Baseline to the end of the study (up to 5 years 8 months))
- Time to Response(Baseline to the end of the study (up to 5 years 8 months))
- Overall Survival(Baseline to the end of the study (up to 5 years 8 months))
- Duration of Follow-up(Baseline to the end of the study (up to 5 years 8 months))
- Best Overall Response (BOR)(Baseline to the end of the study (up to 5 years 8 months))
- Eastern Cooperative Oncology Group (ECOG) Performance Status(Baseline to the Safety Follow-up which occurred 28 days after the last dose of treatment (up to 5 years 8 months).)