Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (TPEx)
2017年4月7日 更新者：Groupe Oncologie Radiotherapie Tete et Cou
Phase II Study of Cetuximab, Docetaxel and Cisplatin as First-line Treatment in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinomas - GORTEC 2008-03 TPEx
PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas.
Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck cancer.
This phase II trial is studying new cetuximab, docetaxel and cisplatin combination named TPEx as first-line treatment in this setting.
研究概览
详细说明
OBJECTIVES:
Primary
- To determine the efficacy of TPEx combination in patients with head and neck cancer in term of objective response rate (RECIST, see statistical consideration) Secondary
- To assess toxicities of TPEx combination
- Determine the efficacy of TPEx combination in patients with head and neck cancer: Best Overall Response , progression-free survival and survival.
- Translational research objective:To better understand the mechanisms of chemoresistance and to identify biomarkers by the analysis of the tumor biopsies (RNA, gene expression profile) and protein profile (plasma samples). Exploratory analyses.
OUTLINE: This is an open-label phase II, multicenter study. Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator. Tumor check-up will be performed every 6 weeks. This study will allow translational research with blood sample and biopsies at baseline before any treatment, during the treatment with TPEx combination (week 6).,After completion of study treatment, patients are followed every 2 months.
研究类型
介入性
注册 (实际的)
54
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Bruxelles、比利时
- Cliniques Universitaires
-
Namur、比利时
- Clinique Sainte Elisabeth
-
Yvoir、比利时
- Clinique universitaire de Mont Godinne UCL
-
-
-
-
-
Bordeaux、法国
- Hopital Saint André
-
Clermont-Ferrand、法国
- Centre Jean Perrin,
-
Dijon、法国
- Centre G-F Leclerc
-
Draguignan、法国
- Centre Hospitalier de la Dracénie
-
Lorient、法国
- Centre Hospitalier de Bretagne Sud
-
Lyon、法国
- Centre Léon Bérard
-
Marseille、法国
- Hôpital de la Timone
-
Rouen、法国
- Centre Henri Becquerel
-
Suresnes、法国
- Hôpital Foch
-
Tours、法国
- CHU Bretonneau
-
Villejuif、法国
- Institut Gustave Roussy
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Histologically proven squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx
- Recurrent disease, incurable disease as determined by surgery or radiation, or metastatic disease
- Measurable or evaluable disease
- Age > 18 years and <= 70 years
- WHO performance status 0 or 1
- Absolute neutrophil count > 1,500/mm3
- Platelets > 150,000/mm3
- Total Bilirubin <= institutional upper limit of normal
- Aspartate aminotransferase < 1.5 X institutional upper limit of normal
- Alanine aminotransferase < 1.5 X institutional upper limit of normal
- Alkaline phosphatase < 2.5 X institutional upper limit of normal
- creatinine clearance > 60 mL/min
- Signed informed consent
- Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment
Exclusion Criteria:
- Previous chemotherapy. Chemotherapy given as part of initial curative therapy and completed more than 6 months before inclusion is allowed
- Previous treatment with total doses of cisplatin > 300 mg/ m2
- Patients must not have any co-existing disease that would preclude cisplatin administration, such as peripheral neuropathy or renal failure
- Surgery (excluding biopsy) or radiotherapy within 4 weeks prior to study entry
- Nasopharyngeal carcinoma, or cancer of sinusal cavities
- Active infection including tuberculosis or HIV positive patient
- Other malignancy within last 5 years except for non-melanoma skin cancer
- No other investigational agent within 30 days prior to study entry
- No other concurrent chemotherapy, immunotherapy, antitumor hormonal therapy (excluding contraceptives and replacement steroids), radiotherapy, or experimental medications
- No prior anti EGFR therapy
- No known brain metastases
- Uncontrolled intercurrent illness that would prevent delivery of protocol therapy
- Patients with a prior history of basal cell carcinoma of the skin or in situ carcinoma of the cervix must have been curatively treated and must have remained disease free for 5 years post diagnosis
- No history of hypersensitivity reaction to drugs on study
- No unstable angina or myocardial infarction within the past 12 months
- No symptomatic congestive heart failure or New York Heart Association (NYHA) class II-IV heart disease
- No serious uncontrolled cardiac arrhythmia
- No other prior or concomitant squamous cell carcinoma
- No other prior or concomitant cancer, except curatively treated basal carcinoma of the skin or in situ cervical cancer, for which the patient has been curatively treated and remains disease-free for the past 5 years
- Patient is pregnant or lactating
- Patients must not have any co-existing condition that would preclude full compliance with the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：cetuximab
Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1.
Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks.
Treatment will be continued until disease progression or unacceptable toxicities according
|
Drug: Cisplatin IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.
No intervention, only biopsy for translational project.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Objective Tumor Response Rate
大体时间：12 weeks (after completion of the 4th cycle of chemotherapy)
|
The objective tumor response rate is evaluated every 6 weeks according to RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT-scan or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. |
12 weeks (after completion of the 4th cycle of chemotherapy)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
总生存期
大体时间：1年
|
1年
|
|
|
无进展生存期
大体时间：1年
|
1年
|
|
|
Grade 1 to 5 Toxicity
大体时间：24 weeks (average)
|
All grade 1 to 5 toxicity are registered during treatment.
Patients have weekly clinical and biological examination.
|
24 weeks (average)
|
|
Best Overall Response
大体时间：12 weeks
|
Tumor response is evaluated every 6 weeks according to RECIST criteria.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, Stable Disease (SD); Best overall Response = CR + PR + SD.
|
12 weeks
|
|
Biomarkers
大体时间：two years
|
two years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Joel GUIGAY、GORTEC
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年9月1日
初级完成 (实际的)
2014年1月1日
研究完成 (实际的)
2014年1月1日
研究注册日期
首次提交
2011年2月1日
首先提交符合 QC 标准的
2011年2月2日
首次发布 (估计)
2011年2月3日
研究记录更新
最后更新发布 (实际的)
2017年5月15日
上次提交的符合 QC 标准的更新
2017年4月7日
最后验证
2016年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.