A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy With or Without Panitumumab as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects Who Fail the Combination Chemotherapy…
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) During the First-line Treatment Phase
研究概览
简要总结
This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed metastatic and/or recurrent Squamous Cell Carcinoma of Head and Neck (SCCHN) determined to be incurable by surgery and/or radiation therapy.
- •Measurable disease by CT scan
- •Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- •Age: 18 years or older
- •Adequate hematologic, renal, metabolic, hepatic & thyroid function
排除标准
- •Prior systemic treatment for metastatic and/or recurrent SCCHN
- •CNS metastases, or nasopharyngeal carcinoma
- •History of interstitial lung disease
- •History of another primary cancer
- •Any co-morbid disease that would increase risk of toxicity
- •Active infection requiring systemic treatment
- •Prior anti-Epidermal Growth Factor receptor (anti-EGFr) antibody therapy
研究组 & 干预措施
Arm 2
control
干预措施: Docetaxel (Drug)
Arm 1
Panitumumab + Docetaxel + Cisplatin
干预措施: Panitumumab (Drug)
Arm 1
Panitumumab + Docetaxel + Cisplatin
干预措施: Cisplatin (Drug)
Arm 1
Panitumumab + Docetaxel + Cisplatin
干预措施: Docetaxel (Drug)
Arm 2
control
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression Free Survival (PFS) During the First-line Treatment Phase
时间窗: Every 6 weeks until disease progression or death, up to 67 months
The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase.
次要结局
- Overall Response Rate (ORR) During the First-line Treatment Phase(Every 6 weeks until disease progression or death, up to 67 months)
- Progression Free Survival (PFS) During the Second-line Treatment Phase(Every 6 weeks until disease progression or death, up to 57 months)
- Time to Response (TTR) During the Second-line Treatment Phase(Every 6 weeks until disease progression or death, up to 57 months)
- Overall Survival (OS) for the Second-line Treatment(Until death, up to 57 months)
- Rate of Disease Control (RDC) During the First-line Treatment Phase(Every 6 weeks until disease progression or death, up to 67 months)
- Duration of Response (DOR) During the First-line Treatment Phase(Every 6 weeks until disease progression or death, up to 67 months)
- Time to Response (TTR) During the First-line Treatment Phase(Every 6 weeks until disease progression or death, up to 67 months)
- Overall Survival (OS) for the First-line Treatment(Until death, up to 67 months)
- Duration of Response (DOR) During the Second-line Treatment Phase(Every 6 weeks until disease progression or death, up to 57 months)
- Overall Response Rate (ORR) During the Second-line Treatment Phase(Every 6 weeks until disease progression or death, up to 57 months)
- Rate of Disease Control (RDC) During the Second-line Treatment Phase(Every 6 weeks until disease progression or death, up to 57 months)