A Double-Blind, Randomized, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-Line Therapy in Patients With Advanced Gastric Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 202
- 主要终点
- Percentage of Participants With Event (Death)
研究概览
简要总结
This 2 arm study will compare the efficacy and safety of bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin in participants who have not received prior chemotherapy for advanced or metastatic gastric cancer. Participants will be randomized to one of two treatment groups Bevacizumab + Capecitabine/Cisplatin (experimental arm) or Placebo + Capecitabine/Cisplatin (control arm).
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
- Double (Participant, Investigator)
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
- •Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable, locally advanced or metastatic disease, not amenable to curative therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
- •Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
排除标准
- •Previous chemotherapy for locally advanced or metastatic gastric cancer
- •Previous platinum or anti-angiogenic therapy
- •Radiotherapy within 28 days of randomization
- •Evidence of Central Nervous System (CNS) metastasis at baseline
研究组 & 干预措施
Bevacizumab, Capecitabine and Cisplatin
Participants will receive bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
干预措施: Bevacizumab (Drug)
Bevacizumab, Capecitabine and Cisplatin
Participants will receive bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
干预措施: Capecitabine (Drug)
Bevacizumab, Capecitabine and Cisplatin
Participants will receive bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
干预措施: Cisplatin (Drug)
Placebo, Capecitabine and Cisplatin
Participants will receive placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
干预措施: Placebo (Drug)
Placebo, Capecitabine and Cisplatin
Participants will receive placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
干预措施: Capecitabine (Drug)
Placebo, Capecitabine and Cisplatin
Participants will receive placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Percentage of Participants With Event (Death)
时间窗: From randomization until death (up to 34 months)
Percentage of participants who died due to any cause was reported. As planned, ad hoc analysis was done for overall survival up to clinical cut-off date of 12 January 2012 (34 months), subsequent to the protocol-defined clinical cut-off date of 13 May 2011 (26 months). Overall survival was defined as the time between randomization and the date of death due to any cause.
Overall Survival
时间窗: From randomization until death (up to 34 months)
Overall survival was defined as the time between randomization and the date of death due to any cause. Overall survival was estimated using Kaplan Meier method. Reported data included censored observations. Participants for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. As planned, ad hoc analysis was done for overall survival up to clinical clinical cut-off date of 12 January 2012 (34 months), subsequent to the protocol-defined clinical cut-off date of 13 May 2011 (26 months).
次要结局
- Percentage of Participants With Progression-Free Survival (PFS) Events (Disease Progression/Death)(From randomization until disease progression or death (up to 26 months))
- Percentage of Participants With PFS Events (Disease Progression/Death) During First-line Therapy(From randomization until disease progression or death (up to 26 months))
- Percentage of Participants With Best Overall Response as Assessed by RECIST During First-Line Therapy(From randomization until disease progression or death (up to 26 months))
- Duration of Response During First-Line Therapy(From randomization until disease progression or death (up to 26 months))
- Percentage of Participants With Disease Progression(From randomization until disease progression or death (up to 26 months))
- Change From Cycle 1 in EORTC QLQ-STO22 Scale Over Time(From Cycle 1 until disease progression (up to 26 months))
- Time to Progression(From randomization until disease progression or death (up to 26 months))
- PFS During First-line Therapy(From randomization until disease progression or death (up to 26 months))
- Percentage of Participants With Disease Control During First-Line Therapy(From randomization until disease progression or death (up to 26 months))
- Progression-Free Survival (PFS)(From randomization until disease progression or death (up to 26 months))
- Change From Cycle 1 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) Scale Over Time(From Cycle 1 until disease progression (up to 26 months))