Weekly Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With SCCHN
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
Docetaxel and cetuximab are FDA-approved for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Cisplatin and carboplatin, while not FDA-approved for SCCHN, have been used as standard of care in SCCHN patients in combination with other drugs. This study evaluates if weekly cisplatin and docetaxel, in combination with cetuximab, is effective in palliative treatment of patients with SCCHN. These drugs will be given intravenously weekly, repeated 3 of every 4 weeks until evidence of disease progression or unacceptable adverse events.
详细描述
Primary Objective:To establish the response rate using RECIST 1 criteria to weekly TPC in patients with metastatic or relapsed squamous cell carcinoma of the head and neck Secondary Objective: To establish the safety profile, progression free and overall survival of weekly TPC in this patient population.
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
- 16 Years 至 —（Child, 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
Cisplatin + Docetaxel + Cetuximab
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
干预措施: Docetaxel (Drug)
Cisplatin + Docetaxel + Cetuximab
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
干预措施: Cisplatin (Drug)
Cisplatin + Docetaxel + Cetuximab
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
干预措施: Cetuximab (Drug)
Cisplatin + Docetaxel + Cetuximab
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 8 weeks
Clinical response for each participant will be assessed after 8 weeks of treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Overall response rate (ORR) was assessed as the sum of the number of participants that experience a complete response (CR) or partial response (PR). The outcome is defined and reported as the number of subjects that responded, a number without dispersion. Other response statuses are included. RECIST v1.1 criteria is defined as follows. * 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 * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria
次要结局
- Grade 3, 4, and 5 Related Adverse Events (Toxicities)(2 years)
- Progression-free Survival (PFS)(24 months)
- Overall Survival (OS)(24 months)
研究者
A. Dimitrios Colevas
Professor of Medicine (Oncology) and Otolaryngology
Stanford University