Phase II Study of Sunitinib Malate in Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Feasibility of Treatment
研究概览
简要总结
This phase II trial is studying how well sunitinib works in treating patients with recurrent and/or metastatic head and neck cancer. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
详细描述
OBJECTIVES:
I. Determine the overall response rate of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with sunitinib malate.
II. Determine the toxicity of this drug in these patients. III. Determine the feasibility of administering this drug to patients with ECOG performance status 2 (cohort B).
OUTLINE: This is a multicenter, cohort study.
Patients are assigned to one of two cohorts according to ECOG performance status (ECOG 0-1 [cohort A] vs ECOG 2 [cohort B]). Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
Arm I
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Feasibility of Treatment
时间窗: While patient remains on treatment, up to 30 weeks
Ability to remain on treatment without dose reduction
Objective Tumor Response Rate (Complete Response [CR] and Partial Response [PR]) Using RECIST Criteria
时间窗: While patient remains on treatment, up to 30 weeks
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
次要结局
- Progression-free Survival(Up to 2 years)
- Overall Survival(Up to two years)