Study of PEP02, Irinotecan or Docetaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
A Randomized Phase II Study of PEP02, Irinotecan or Docetaxel as a Second Line Therapy in Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
研究概览
详细说明
Palliative chemotherapy has been shown to improve survival compared with best supportive care alone in patients with unresectable or recurrent gastric cancer. There is no standard second-line chemotherapy for advanced gastric cancer and no randomized-controlled trial data suggest a benefit of second-line chemotherapy compared with supportive care alone. Response rates of second-line therapy in phase II trials are similar to those seen for other cancers that are more commonly retreated. Combination therapy may achieve higher response rates than single agents, however, the survival outcome are the same. In addition, data suggest that patients may obtain symptomatic benefits from second-line therapy. In comparison to the toxicity profile of single agent with combination regimen, patients are more tolerable to single agent therapy than combination.
Based on the previous clinical experience in second line chemotherapy of advanced gastric cancer, the single agent of PEP02, irinotecan and docetaxel are selected as the regimens for this randomized phase II study. The efficacy and toxicity outcome of the three-arm design will be a valuable reference for future combination therapy or phase III study design.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Rijeka、克罗地亚、51 000
- University Hospital Centre Rijeka
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Zagreb、克罗地亚、10 000
- University Hospital Centre Zagreb
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Zagreb、克罗地亚、10 000
- University Hospital Centre Dubrava
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Chiayi、台湾
- Chang Gung Memorial Hospital - Chiayi
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LinKou、台湾
- Chang Gung Memorial Hospital - Linkou
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Tainan、台湾、704
- National Cheng Kung University Hospital
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Taipei、台湾、112
- Taipei Veterans General Hospital
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Taipei、台湾、25115
- Mackay Memorial Hospital
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Seoul、大韩民国、135-710
- Samsung Medical Center
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Seoul、大韩民国、138-736
- Asan Medical Center
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Seoul、大韩民国、410-769
- National Cancer Center
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Mostar、波斯尼亚和黑塞哥维那、36 000
- Clinical hospital Mostar
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Sarajevo、波斯尼亚和黑塞哥维那、71 000
- Clinical Centre University of Sarajevo
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Cambridge、英国、CB2 2QQ
- Addenbrookes Hospital Oncology Center
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London、英国、SE19RT
- Guy's & St Thomas' NHS Foundation Trust
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Maidstone、英国、ME16 9QQ
- Kent Oncology Centre, Maidstone Hospital
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Southampton、英国、SO16 6YD
- Southampton University Hospital
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Surrey、英国、SM2 5PT
- The Royal Marsden Hospital
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Barcelona、西班牙、08035
- Hospital Universitario Vall d'Hebron
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Elche、西班牙、03203
- Hospital General Universitario de Elche
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Madrid、西班牙、28040
- Hospital Clinico San Carlos
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Santander、西班牙、39008
- Hospital Universitario Marques de Valdecilla
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced (unresectable) or metastatic adenocarcinoma of gastric or gastroesophageal junction
- Failed to only one systemic chemotherapy for locally advanced or metastatic disease, including patients whose diseases recur within 6 months after (neo)adjuvant chemotherapy. Chemotherapy administered with concurrent radiotherapy is NOT considered as systemic chemotherapy.
- Have at least one measurable lesion according to the RECIST criteria
- Aged above or equal to 18 years, at the time of acquisition of informed consent
- With ECOG performance status 0, 1, or 2
- Life expectancy equal to or more than 3 months
- With adequate organ and marrow function as defined below:
- With ability to understand and the willingness to sign a written Informed Consent Form
Exclusion Criteria:
- Had systemic chemotherapy within 3 weeks before the commencement of study treatment
- Had radiotherapy within 4 weeks before the commencement of study treatment
- With known brain metastasis
- With active multiple cancers or had treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
- With prior irinotecan or taxane (paclitaxel, docetaxel) treatment
- Have received irradiation affecting > 30% of the active bone marrow
- Had major surgery within 4 weeks of the start of study treatment (laparotomy, line placement is not considered major surgery)
- Have not recovered from prior treatments
- With preexisting peripheral neuropathy > grade 2
- With history of allergic reaction to liposome product or other drugs formulated with polysorbate
- With uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, active gastrointestinal bleeding, watery stools, central nervous system disorders or psychiatric illness/social situation that would limit compliance with study requirements or judged to be ineligible for the study by the investigator
- Have received any investigational agents within 3 weeks preceding the start of study treatment
- Pregnant or breastfeeding females (a pregnancy test must be performed on all female patients who are of child-bearing potential before entering the study, and the result must be negative)
- With intestinal obstruction
- Have received St. John's Wort, CYP3A4 inducing anticonvulsants (phenytoin, phenobarbital, and carbamazepine), rifampin and rifabutin within two weeks, or ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem and verapamil within one week before the administration of study medications
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 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. PEP02
liposome irinotecan
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120 mg/m2, IV infusion for 90 minutes on day 1 of each 21 day as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops.
其他名称:
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有源比较器:2. irinotecan
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300 mg/m2, IV infusion on day 1 of each 21 day as a treatment cycle.
Number of Cycles: until progression or unacceptable toxicity develops.
其他名称:
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有源比较器:3. docetaxel
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75 mg/m2, IV infusion for 60 minutes on day 1 of each 21 day as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops.
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 |
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客观肿瘤反应
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次要结果测量
结果测量 |
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progression-free survival, duration of tumor response, time to progression, time to treatment failure, disease control rate, 1-year survival rate,and overall survival; pharmacokinetics and pharmacogenetics of PEP02 and irinotecan
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合作者和调查者
赞助
调查人员
- 首席研究员:David Cunningham、The Royal Marsden Hospital, London & Surrey, UK
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.
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