A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer in Patients Who Have Failed Therapy With an Irinotecan and Fluoropyrimidine Regimen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Number of Patients With an Objective Disease Progression Event
研究概览
简要总结
The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Progression on or following treatment for metastatic colorectal cancer
- •Have failed therapy with an irinotecan and fluoropyrimidine containing regimen
- •Have World Health Organisation (WHO) performance status 0-2 and life expectancy >12 weeks
排除标准
- •Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR Prior monoclonal antibodies are permitted, (eg, cetuximab, bevacizumab)
- •Previous adjuvant therapy with irinotecan within 12 months of randomisation
- •More than one prior course of chemotherapy for treatment of metastatic colorectal cancer
研究组 & 干预措施
3
FOLFOX + high dose vandetanib
干预措施: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid (Drug)
1
FOLFOX + Placebo vandetanib
干预措施: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid (Drug)
2
FOLFOX + low dose vandetanib
干预措施: Vandetanib (Drug)
2
FOLFOX + low dose vandetanib
干预措施: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid (Drug)
3
FOLFOX + high dose vandetanib
干预措施: Vandetanib (Drug)
结局指标
主要结局
Number of Patients With an Objective Disease Progression Event
时间窗: RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (5 March 2008 +/-3 days)
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
次要结局
未报告次要终点