A Randomized Phase II Study of Docetaxel in Combination With Oxaliplatin With or Without 5-FU or Capecitabine in Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Time to Progression
研究概览
简要总结
This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm. The optimal dose was administered in the Part II study. Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population.
Primary objective:
- To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease (part II).
Secondary objectives:
- To establish the safety profile.
- To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO) criteria
- To assess the Overall Survival (OS)
详细描述
The purpose of this study (Part II) was to evaluate the time to progression in the 3 arms at an optimal dose level of docetaxel and oxaliplatin defined during a prior pilot (Part I) phase study. The estimated duration of treatment was to be 6 months. Treatment was to be administered up to progression, unacceptable toxicities, or withdrawal of consent. The reason and date of removal of all participants was documented on the case report form.
Participants who ended treatment but had not yet progressed (e.g. unacceptable toxicities or withdrawal of consent) were be followed every 8 weeks with a complete tumor assessment until documented progression or further anti-tumor therapy. Then, they would be followed every 3 months after progression for survival status; date of death or progression were reported. Participants who ended treatment for progression, were to be followed every 3 months until death. Date of death was reported. The planned duration of the study was 30 months.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TE (Taxotere and Eloxatin)
Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin). Each chemotherapy cycle was repeated every 21 days.
Participants received either the optimal or non-optimal dose for Taxotere and Eloxatin. Participants who received the optimal dose for Taxotere and Eloxatin were analyzed in this study.
干预措施: Docetaxel + Oxaliplatin (Drug)
TEF (Taxotere, Eloxatin and 5-FU)
Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin) and 5-FU (5-Fluorouracil). Each chemotherapy cycle was repeated every 14 days.
Participants received either the optimal or non-optimal dose for Taxotere, Eloxatin and 5-FU. Participants who received the optimal dose for Taxotere, Eloxatin and 5-FU were analyzed in this study.
干预措施: Docetaxel + Oxaliplatin + 5-FU (Drug)
TEX (Taxotere, Eloxatin and Xeloda)
Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin) and capecitabine (Xeloda). Each chemotherapy cycle was repeated every 21 days.
Participants received either the optimal or non-optimal dose for Taxotere, Eloxatin and Xeloda. Participants who received the optimal dose for Taxotere, Eloxatin and Xeloda were analyzed in this study.
干预措施: Docetaxel + Oxaliplatin + Capecitabine (Drug)
结局指标
主要结局
Time to Progression
时间窗: every 8 weeks up to a maximum of 36 months
The number of months measured from the day of randomization to the first tumor progression according to World Health Organization (WHO) criteria evaluation of cancer response, or death from any cause. WHO Criteria for Progressive Disease: ≥ 25% increase in the size of at least one bidimensionally or unidimensionally measurable lesion.
次要结局
- Best Overall Response Rate (ORR)(every 8 weeks up to a maximum of 36 months)
- Overall Survival (OS)(up to a maximum of 36 months)