Open Label, Phase II Study of Capecitabine (Xeloda®) as Fluoropyrimidine of Choice in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer Suitable for Treatment With a Fluoropyrimidine-Based Regimen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 158
- 主要终点
- Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)
研究概览
简要总结
This study will assess the safety and efficacy of Xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the chemotherapy regimen used. 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
- Non 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;
- •advanced or metastatic gastric cancer;
- •Eastern Cooperative Oncology Group (ECOG) <=2.
排除标准
- •previous chemotherapy (except adjuvant or neoadjuvant treatment >=6 months prior to study);
- •evidence of central nervous system (CNS) metastasis;
- •history of another malignancy within the last 5 years (except for successfully treated basal cell cancer of skin, or in situ cancer of the cervix);
- •clinically significant cardiac disease.
研究组 & 干预措施
Cisplatin / Capecitabine
Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
干预措施: Cisplatin (Drug)
Cisplatin / Capecitabine
Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
干预措施: Capecitabine (Drug)
Epirubicin / Cisplatin / Capecitabine
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks.
干预措施: Epirubicin (Drug)
Epirubicin / Cisplatin / Capecitabine
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks.
干预措施: Cisplatin (Drug)
Epirubicin / Cisplatin / Capecitabine
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks.
干预措施: Capecitabine (Drug)
Epirubicin / Oxaliplatin / Capecitabine
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks.
干预措施: Epirubicin (Drug)
Epirubicin / Oxaliplatin / Capecitabine
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks.
干预措施: Capecitabine (Drug)
Epirubicin / Oxaliplatin / Capecitabine
Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks.
干预措施: Oxaliplatin (Drug)
Docetaxel / Cisplatin / Capecitabine
Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
干预措施: Cisplatin (Drug)
Docetaxel / Cisplatin / Capecitabine
Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
干预措施: Docetaxel (Drug)
Docetaxel / Cisplatin / Capecitabine
Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)
时间窗: Approximately 3.25 years
次要结局
- Overall Response Rate (ORR)(Approximately 3.25 years)
- Progression-Free Survival (PFS)(Approximately 3.25 years)
- Overall Survival (OS)(Approximately 3.25 years)
- Time to Response(Approximately 3.25 years)
- Duration of Response(Approximately 3.25 years)