Cetuximab 5-FU and Cisplatin or Carboplatin Versus Cetuximab With Paclitaxel and Carboplatin Treatment of Metastatic Squamous Cell Carcinoma of Head and Neck
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Progression free survival
研究概览
简要总结
Primary To investigate in patients with relapsed or metastatic squamous cell carcinoma of the head and neck whether progression free survival (PFS) in the arm with cetuximab, paclitaxel and carboplatin based chemotherapy is not markedly worse than PFS in the arm with cetuximab and 5-FU, cisplatin or carboplatin based chemotherapy.
Secondary
To compare in patients with relapsed or metastatic squamous cell carcinoma of the head and neck the following study variables between both treatment arms:
- Best overall response
- Duration of response
- Time to treatment failure
- Overall survival
- Safety
详细描述
Recurrent and/or metastatic SCCHN patients are, by definition patients with recurrent disease and/or with newly diagnosed distant metastases, although this group of patients has a very heterogeneous disease characteristic, they share a dismal prognosis that has changed little in the past 30 years. The median survival time remains around 6-8 months with a poor quality of life. Patients with resectable locoregionally recurrent SCCHN may benefit from surgery. Patients with recurrent SCCHN who are not suitable for curative salvage surgery or re-irradiation, and patients who have distant metastases, usually receive CT (Cohen EE et al.) A number of compounds demonstrate single-agent activity in recurrent and/or metastatic disease including cisplatin, carboplatin, methotrexate, 5-FU, bleomycin and the taxanes ( Scantz SP et al). Cisplatin is one of the most active agents identified for head and neck cancer, with carboplatin providing an alternative for patients unable to tolerate cisplatin. While carboplatin is associated with lower response rates than cisplatin, there appears to be no difference between the agents in terms of survival
Cetuximab is a targeted therapeutic agent, a chimeric IgG1 monoclonal antibody that specifically binds to the EGFR with high affinity, internalising the receptor and preventing the ligands EGF and TGF-alfa from interacting with the receptors and thus effectively blocking ligand-induced EGFR phosphorylation. In addition, cetuximab has been found to potentiate the effects of chemotherapy and radiotherapy in experimental systems. The dose of cetuximab has been found to be generally safe and effective in several studies in major tumor types expressing the EGFR. These included colorectal cancer, squamous cell carcinoma of the head and neck and non-small cell lung cancer, with cetuximab given either in combination studies with chemotherapy and radiotherapy or as monotherapy. The main side effects of cetuximab monotherapy are hypersensitivity- and acne-like skin reactions.
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 75 Years（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
- •> 75 years
- •Nasopharyngeal cancer and cancer of the paranasal sinuses
- •Inability to follow the treatment and evaluation schedule
- •Any other condition or therapy which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives
- •Pregnant or nursing females or male or female of child-bearing potential not using adequate methods of birth-control
- •Patients with active infections or any other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment
- •Known hypersensitivity to any of the components of the treatment
- •Legal incapacity
- •Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
- •Patients with clinically relevant neuropathy
- •Previously treated for relapsed or metastatic SCCHN except radiotherapy for previously treated relapse if terminated > 3 months before start of treatment.
- •Previously treated with cetuximab, cisplatin/carboplatin, 5-FU or taxanes for locally advanced SCCHN within 3 months before study entry.
研究组 & 干预措施
Arm A: cetuximab with 5FU and carboplatin or cisplatin
Arm A:Day 1 Cetuximab 400 mg/m2 iv 120 minutes Day 8 and 15 Cetuximab 250 mg/m2 iv 60 minutes Day 1 Cisplatin 100mg/m2 or Carboplatin AUC 5 day 1-4 5-Fluorouracil 1000 mg/m2 iv 24 h maintenance treatment thereafter with cetuximab 500 mg/m2 every second week until PD or toxicity
干预措施: Cetuximab (Drug)
Arm B: cetuximab paclitaxel and carboplatin
Arm B day 1 Cetuximab 400 mg/m2 iv 120 minutes Day 8 and 15 Cetuximab 250 mg/m2 iv 60 minutes day 1 Paclitaxel 175 mg/m2 day 1 Carboplatin AUC 5 treatment for 6 cycles thereafter maintenance treatment day 1 Cetuximab 500 mg/m2 every second week treatment until progress or unacceptable toxicity
干预措施: Cetuximab (Drug)
结局指标
主要结局
Progression free survival
时间窗: 3 years
To investigate in patients with relapsed or metastatic squamous cell carcinoma of the head and neck whether progression free survival (PFS) in the arm with cetuximab, paclitaxel and carboplatin based chemotherapy is not markedly worse than PFS in the arm with cetuximab and 5-FU, cisplatin or carboplatin based chemotherapy.
次要结局
- Best overall response(3 years)
研究者
Signe Friesland
MD, PhD
Karolinska University Hospital