Phase II, Multicenter Study Evaluating G-CSF as Primary Prophylaxis for Neutropenia Associated With First-line Chemotherapy Regimen FOLFIRI and Bevacizumab in Patients With Metastatic Colorectal Cancer Who Are Homozygous for UGT1A1*28 Polymorphism, the Promoter of the Gene Encoding for the Enzyme UGT1A1
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Rate of neutropenia grade 4 or fever
研究概览
简要总结
RATIONALE: G-CSF may prevent or control neutropenia caused by first-line therapy in patients with metastatic colorectal cancer.
PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia during first-line treatment with chemotherapy and bevacizumab in patients with metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Determine if primary prophylaxis comprising filgrastim (G-CSF) makes it possible to obtain neutropenia lower than grade 4 or a 30% decrease in fever in patients with metastatic colorectal cancer receiving first-line FOLFIRI and bevacizumab and who are homozygous for allele UGT1A1*28 (genotype 7/7), a promoter of the gene coding for enzyme UGT1A1.
Secondary
- Evaluate the objective response rate at 6 months of treatment with FOLFIRI and bevacizumab according to RECIST criteria.
- Evaluate the toxicity (excluding neutropenia) of FOLFIRI and bevacizumab according to NCI-CTC v. 2.0.
- Determine progression-free and overall survival.
- Determine the time to treatment failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（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
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
干预措施: leucovorin calcium (Drug)
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
干预措施: bevacizumab (Biological)
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
干预措施: filgrastim (Biological)
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
干预措施: fluorouracil (Drug)
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
FOLFIRI-bévacizumab avec G-CSF en prophylaxie primaire
干预措施: irinotecan hydrochloride (Drug)
结局指标
主要结局
Rate of neutropenia grade 4 or fever
时间窗: 2013
Toxicities by NCI-CTC v. 2.0
时间窗: 2013
次要结局
- Objective response at 6 months by RECIST(2013)
- Tolerance (except neutropenia) by NCI-CTC v. 2.0(2013)
- Time to treatment failure(2013)
- Overall survival(2013)
- Progression-free survival(2013)