NCT01370876终止2 期
A Phase II Trial Evaluating Efficacy and Safety of Opatin® (Oxaliplatin)/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer and to assess the safety profile of these treatment regimen.
详细描述
To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer.
To assess the safety profile of these treatment regimen. To evaluate the duration of response of oxaliplatin/5-FU.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must have been histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) except nasopharyngeal cancer.
- •Patients must have recurrent or metastatic disease and for which curative surgery or radiotherapy do not exist or are no longer effective.
- •Prior to entering the protocol treatment, it has to be more than 6 months interval between previous systemic chemotherapy and protocol treatment.
- •The disease must have been measurable by computed tomographic (CT) scan or MRI (done within 30 days of study entry) and the diameter of the target tumor is at least more than 1 cm.
- •Patients must be 20 years of age and 75 years of age.
- •Patients must have an ECOG performance status score
- •Patient's hematologic function, liver function and renal function must meet the eligibility requirements.
- •Patients must sign the informed consent.
排除标准
- •Patients with known hypersensitivity history to Platinum compounds or to 5-Fluorouracil.
- •Patients with brain metastases.
- •Patients with bone metastases only.
- •Patients with pregnancy or breast-feeding.
- •Patient with CTC (NCI Common Toxicity Criteria) grade 2 peripheral neuropathy of any cause that is clinically detectable.
- •Patients who have serious concomitant illness that might be aggravated by chemotherapy and other conditions which will be judged by physician's discretion.
- •Patients who are receiving other anticancer cancer drug(s) for SCCHN.
研究组 & 干预措施
Oxaliplatin/5-FU
Experimental
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Objective response rate
时间窗: every 12 weeks
To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer
次要结局
- Safety(Each patient will be followed for 30 days after the last dose of study medication)
研究者
研究点 (1)
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