Trial of Panitumumab Cisplatin, Fluourouracil and Docetaxel in Locally Advanced or Metastatic Gastric Cancer
2015年10月7日 更新者：Hellenic Oncology Research Group
Phase I/II, Multicenter, Single-Arm Clinical Trial of Panitumumab in Combination With Cisplatin, Fluourouracil and Docetaxel (DCF) in Locally Advanced or Metastatic Cancer of the Stomach and Gastro-oesophageal Junction.
Investigators propose to study the effect of panitumumab when combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in previously untreated patients with advanced cancer of the stomach.
研究概览
详细说明
Investigators propose a phase I/II study in order to evaluate the effect of panitumumab when combined with an active regimen, such as DCF (Docetaxel/Cisplatin/Fluourouracil), in chemotherapy - naive patients with advanced cancer of the stomach.
Investigators hypothesize that the addition of panitumumab to DCF regimen in advanced cancer of the stomach and gastroesophageal junction is feasible, well tolerated and could achieve an objective response rate of greater than 40%.
The 2-weekly schedule of DCF will be used as chemotherapy since a recently presented trial demonstrated a comparable efficacy but a more favourable toxicity profile comparable to the 3-weekly schedule.
研究类型
介入性
注册 (实际的)
51
阶段
- 阶段2
- 阶段1
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
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Athens、希腊
- 401 Military Hospital of Athens
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Athens、希腊
- Air Forces Military Hospital of Athens
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Athens、希腊
- "IASO" General Hospital of Athens
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Chania、希腊
- "Ag.Georgios" General Hospital of Chania
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Heraklion、希腊
- University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece
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Larissa、希腊
- State General Hospital of Larissa
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Piraeus、希腊
- "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
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Thessaloniki、希腊
- "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
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Thessaloniki、希腊
- Diabalkaniko General Hospital of Thessaloniki
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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
20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 inoperable locally advanced or metastatic adenocarcinoma of the stomach (including adenocarcinoma of the gastrooesophageal junction)
- Patient's age between 20 and 70 years old
- Measurable disease defined by RECIST criteria
- Patients with non-measurable disease could be enrolled in the phase I part of the study
- ECOG performance status ≤ 1
- Hgb ≥ 8g/dL, WBC ≥ 3 x 109/L , neutrophils count ≥ 1.5 x 109/L , platelets ≥100 x 109/L, Creatinine clearance ≥50 mL/min, Total bilirubin ≤ 1.5 X UNL, AST, ALT and ALP ≤ 2.5 x UNL
- No prior chemotherapy or more than 6 months from adjuvant chemotherapy or chemo-radiation
- Estimated life expectancy more than 3 months
- Written informed consent
Exclusion Criteria:
- Gastrointestinal bleeding
- Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's discomfort
- CNS metastases
- History of hypersensitivity to fluoropyrimidines, docetaxel or platinum compounds
- Any previous chemotherapy or radiotherapy for advanced disease
- Patient pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment
- Patient (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment
- Known hypersensitivity reaction to the component of the treatment
- Active infection or malnutrition or bowel obstruction
- Legal incapacity or limited legal capacity
- Definite contraindications for the use of corticosteroids
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
- Chronic inflammation of the bowel
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
- Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
- A second primary tumor other than non-melanoma skin cancer or in situ cervical cancer
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 |
|---|---|
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实验性的：1
Panitumumab plus DCF
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其他名称：
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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 |
|---|---|---|
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Objective response rate
大体时间：Every 8 weeks
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Patients will be followed for disease evaluation every eight (8) weeks from the first day of chemotherapy until the first documentation of disease progression
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Every 8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Progression Free Survival
大体时间：1 year
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Patients will be evaluated from the date of the first chemotherapy cycle until the date of first documented progression or date of death from any cause, whichever came first
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1 year
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Overall Survival
大体时间：1 year
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Patients will be evaluated for overall survival from the date of the first chemotherapy cycle until the date of death from any cause
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1 year
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Maximum Tolerated Dose of the combination
大体时间：Up to 4 weeks
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Patients will be evaluated for toxicity profil on Day 1 of the first two chemotherapy cycle (cycle repeated every 2 weeks)
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Up to 4 weeks
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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。
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
2011年7月1日
初级完成 (实际的)
2015年1月1日
研究完成 (实际的)
2015年1月1日
研究注册日期
首次提交
2012年10月2日
首先提交符合 QC 标准的
2012年10月25日
首次发布 (估计)
2012年10月30日
研究记录更新
最后更新发布 (估计)
2015年10月8日
上次提交的符合 QC 标准的更新
2015年10月7日
最后验证
2015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.