EUCTR2008-006923-30-DE进行中（未招募）不适用
cetuximab, fluorouracil ( 5-FU) and cisplatin alone or with docetaxel in recurrent and/or metastatic head and neck cancer - CeFCiD - 1108
Charité Campus Benjamin Franklin0 个研究点目标入组 180 人开始时间: 2009年7月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Signed written informed consent
- •Male or female > 18 years of age
- •Histologically confirmed recurrent and/or metastatic stage III/IV SCCHN, not suitable for local therapy
- •Patients with recurrent and/or metastatic SCCHN, who are not candidates for local therapies
- •At least one measurable lesion according to the RECIST criteria (> 10 mm with spiral CT or > 20 mm with conventional CT) must be present
- •ECOG Performance Status 0-1
- •Adequate bone marrow function: leucocytes > 3.0 x 109/L, platelets > 80 x 109/L, hemoglobin > 10.0 g/dL
- •Adequate liver function: Bilirubin < upper normal limit, SGOT, SGPT, AP, ?-GT < 3 x ULN
- •Adequate renal function: serum creatinine < 1.5 mg/dl
- •If of childbearing potential, willingness to use effective contraceptive method (Pearl Index < 1) for the study duration and 2 months post-dosing
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior systemic treatment with cetuximab and docetaxel during the last 6 months
- •Surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry
- •Other serious illness or medical conditions:
- •-Unstable cardiac disease despite treatment, congestive heart failure NYHA grade 3 and 4;
- •-Significant neurologic or psychiatric disorders including dementia or seizures;
- •-Active uncontrolled infection;
- •-Active disseminated intravascular coagulation;
- •-Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
- •Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 2 and/or ototoxicity grade 2, except if
- •due to trauma or mechanical impairment due to tumor mass
- •Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease.
- •Having participated in another clinical trial or having received any investigational agent 30 days before study entry
- •Known allergic/hypersensitivity reaction to any of the components of the treatment
- •Pregnancy (absence confirmed by serum/urine ?-HCG) or breast-feeding
- •Other active malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- •Legal incapacity or limited legal capacity
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- •Prior accommodation in an institution under officially or judicially orders (§40 p.1 No. 4 AMG)
研究者
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