A Single Arm, Open-label Multicenter Phase II Trial of Temsirolimus in Patients With Relapsed/Recurrent Squamous Cell Cancer of the Head and Neck (HNSCC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 14
- 主要终点
- Progression free rate
研究概览
简要总结
The purpose of this study is to determine whether temsirolimus is effective in the treatment of relapsed/recurrent squamous cell cancer of the head and neck (HNSCC)
详细描述
Temsirolimus is an inhibitor of the mammalian target of rapamycin (mTOR), a crucial regulator of cell cycle progression. It was approved in the treatment of advanced renal cell carcinoma. Temsirolimus demonstrated also antitumor activity in a variety of other human cancer models, such as gliomas, rhabdomyosarcomas, neuroblastomas, prostata and breast cancer through induction of apoptosis or inhibition of proliferation. A similar effect was noted in HNSCC cell lines.
This is the first study evaluating the efficacy and safety of temsirolimus in platinum/cetuximab-refractory HNSCC.
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
- •Signed written informed consent must be given prior to study inclusion
- •Histological or cytological confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC)
- •Measurable progressive disease after platinum-based radiochemotherapy or recurrence or metastatic progressive disease after 1st line platinum-based chemotherapy
- •Patients with loco-regional recurrence need to be progression free for at least 6 months after platinum-based radiochemotherapy, if locoregional recurrence is the only lesion
- •Cetuximab must have been included in at least one prior line of therapy
- •Disease is not amenable to surgery, radiotherapy or platinum-based chemotherapy
- •At least one measurable lesion according to RECIST (Version 1.0) criteria
- •Age > 18 years
- •ECOG performance status 0-2
- •Brain metastases require completion of local therapy with discontinuation of steroids prior to start of treatment
- •If of childbearing potential, willingness to use effective contraceptive method (double barrier method) for the study duration and 2 months after last dose
- •Willingness and ability to comply with the protocol
- •Adequate bone marrow function, liver and renal function
排除标准
- •Live expectancy less than 3 months
- •Anticancer treatment during the last 30 days prior to start of treatment, including systemic therapy, radiotherapy or major surgery
- •Participation in a clinical trial within the last 30 days prior to study treatment
- •Serious illness or medical condition other than the disease under study
- •Other malignancies within 3 years, with exception of HNSCC, history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- •Inability to potentially complete follow up and treatment per protocol for psychological, familial, sociological or geographical reasons
- •Pregnancy or breast feeding
- •Known allergic/hypersensitivity reaction to any component of the treatment
- •Concurrent treatment with oral anticoagulants
- •Uncontrolled diabetes: fasting serum glucose > 2.0 ULN
- •Active or uncontrolled infection
结局指标
主要结局
Progression free rate
时间窗: at week 12
The primary endpoint is the patients free of progression (PFR) at week 12 based on CT or MRI scans evaluated according to RECIST criteria.
次要结局
- Time to disease progression(6 weeks (average))
- Toxicity of temsirolimus(12 weeks)
- Objective response rate(at week 12)
- Overall survival(at week 12)
研究者
Viktor Grünwald
Associate Professor MD
Hannover Medical School