A Phase II Study of Modified FOLFOX-6 Chemotherapy as First-line Treatment of Metastatic Colorectal Cancer in Patients Who Have Received Oxaliplatin-based Adjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Sanofi
- 试验地点
- 1
- 主要终点
- Primary endpoint for the first thirteen patients according to the Simons Design: Clinical DCR (Disease Control Rate) at the end of stage I, based on Response Evaluation Criteria on Solid Tumors (RECIST) criteria.
研究概览
简要总结
Primary Objective:
- To demonstrate that re-challenge with an oxaliplatin based regimen (modified FOLFOX-6) will provide a clinical disease control rate (DCR) of at least 20% at the end of the chemotherapy.
Secondary Objective:
- To evaluate other measures of tumour's responses and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Patients will receive modified FOLFOX-6 regimen:
- oxaliplatin 85mg/m2, day 1 (given as a 2-hour infusion)
- LV 400mg/m2, day 1 (given as a 2-hour infusion simultaneous to oxaliplatin)
- 5-FU given as a bolus IV 400mg/m2 dose on day 1 followed by 2400mg/m2 continuous infusion over 46 hours (day 1 and 2)
A cycle is defined as 2 weeks. Patients will receive cycles of modified FOLFOX-6 regimen every 2 weeks up to a maximum of 8 cycles. Use of bevacizumab is at the discretion of the treating physician.
干预措施: OXALIPLATIN (SR96669) (Drug)
1
Patients will receive modified FOLFOX-6 regimen:
- oxaliplatin 85mg/m2, day 1 (given as a 2-hour infusion)
- LV 400mg/m2, day 1 (given as a 2-hour infusion simultaneous to oxaliplatin)
- 5-FU given as a bolus IV 400mg/m2 dose on day 1 followed by 2400mg/m2 continuous infusion over 46 hours (day 1 and 2)
A cycle is defined as 2 weeks. Patients will receive cycles of modified FOLFOX-6 regimen every 2 weeks up to a maximum of 8 cycles. Use of bevacizumab is at the discretion of the treating physician.
干预措施: 5-FLUOROURACIL (5-FU) (Drug)
1
Patients will receive modified FOLFOX-6 regimen:
- oxaliplatin 85mg/m2, day 1 (given as a 2-hour infusion)
- LV 400mg/m2, day 1 (given as a 2-hour infusion simultaneous to oxaliplatin)
- 5-FU given as a bolus IV 400mg/m2 dose on day 1 followed by 2400mg/m2 continuous infusion over 46 hours (day 1 and 2)
A cycle is defined as 2 weeks. Patients will receive cycles of modified FOLFOX-6 regimen every 2 weeks up to a maximum of 8 cycles. Use of bevacizumab is at the discretion of the treating physician.
干预措施: LEUCOVORIN (LV) (Drug)
1
Patients will receive modified FOLFOX-6 regimen:
- oxaliplatin 85mg/m2, day 1 (given as a 2-hour infusion)
- LV 400mg/m2, day 1 (given as a 2-hour infusion simultaneous to oxaliplatin)
- 5-FU given as a bolus IV 400mg/m2 dose on day 1 followed by 2400mg/m2 continuous infusion over 46 hours (day 1 and 2)
A cycle is defined as 2 weeks. Patients will receive cycles of modified FOLFOX-6 regimen every 2 weeks up to a maximum of 8 cycles. Use of bevacizumab is at the discretion of the treating physician.
干预措施: BEVACIZUMAB (Drug)
结局指标
主要结局
Primary endpoint for the first thirteen patients according to the Simons Design: Clinical DCR (Disease Control Rate) at the end of stage I, based on Response Evaluation Criteria on Solid Tumors (RECIST) criteria.
时间窗: At the end of 8 cycles or end of treatment which occurs first.
次要结局
- Adverse events(At each visit, i.e. every two weeks)
- Progression-free survival (PFS)(evaluated at 10 weeks, 16 weeks and 40 weeks)
- Duration of response(evaluated at 10 weeks, 16 weeks and 40 weeks)
- Overall response rate of stage I and II(evaluated at week 14)