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A Study of Docetaxel in Combination With Capecitabine in Stomach and Esophagus Cancers

2016年1月10日 更新者:Nathan Bahary, MD、University of Pittsburgh

A Phase II Study of Weekly Docetaxel (Taxotere®) in Combination With Capecitabine (Xeloda) in Advanced Gastric and Gastro-Esophageal Adenocarcinomas.

This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas.

研究概览

地位

终止

条件

详细说明

This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas. Docetaxel 30mg/m2 will be administered on days 1 and 8 of each cycle and capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14) of each cycle. Each cycle is 21 days. Subjects will receive unlimited cycles of docetaxel and capecitabine until there is evidence of disease progression or unacceptable side effects.

研究类型

介入性

注册 (实际的)

40

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

    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15232
        • University of Pittsburgh Medical Center

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 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Have histologically or cytologically confirmed locally advanced (unresectable) or metastatic adenocarcinoma of gastric, gastro-esophageal, or esophageal origin.
  2. Must have measurable or evaluable disease.
  3. Received adjuvant therapy are eligible if adjuvant therapy was given ≥ 6 months prior to the diagnosis of metastatic disease.
  4. Life expectancy greater than 12 weeks.
  5. ECOG performance status < 2.
  6. Adequate organ and marrow function.
  7. Preexisting peripheral neuropathy if present must be grade 0 or 1.
  8. Women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 3 months thereafter. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential

Exclusion Criteria:

  1. No chemotherapy or radiotherapy within 4 weeks
  2. Not receiving any other investigational agents or participate in any investigational drug study within 4 weeks preceding the start of study treatment.
  3. Patients with known brain metastases shall be excluded from this clinical trial
  4. Patients with evidence or history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant that precludes informed consent or interferes with the compliance of oral drug intake will also be excluded.
  5. History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
  6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel, capecitabine or 5-FU.
  7. Uncontrolled intercurrent illness
  8. Pregnant or breast feeding women are excluded from this study
  9. Inability to swallow tablets or those who have malabsorptive symptoms will be excluded.
  10. HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel or capecitabine.
  11. Prior use of docetaxel or capecitabine is not allowed ( Prior 5FU therapy is allowed).
  12. Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
  13. Major surgery ( i.e laparotomy, line placement is not considered major surgery)within 4 weeks of the start of study treatment, without complete recovery.
  14. Known, existing uncontrolled coagulopathy.
  15. Patients on anticonvulsants that are metabolized via P450 3A4 pathway.

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:Docetaxel + Capecitabine

Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.

Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).

Each cycle will consist of 21 days. Cycle 2 will begin on day 22.

Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.

Cycle 2 will begin on day 22.

Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).

Each cycle will consist of 21 days.

Cycle 2 will begin on day 22.

其他名称:
  • Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
  • Each cycle will consist of 21 days.
  • Cycle 2 will begin on day 22.

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
Overall Survival
大体时间:2 years
The time interval between the date on which a patient first received protocol treatment and the documented date of death.
2 years

次要结果测量

结果测量
措施说明
大体时间
Overall Response Rate
大体时间:Every 2 cycles (6 weeks)
The number of responders (complete responders + partial responders) divided by the number of evaluable patients.
Every 2 cycles (6 weeks)

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

2005年4月1日

初级完成 (实际的)

2008年12月1日

研究完成 (实际的)

2008年12月1日

研究注册日期

首次提交

2005年9月12日

首先提交符合 QC 标准的

2005年9月12日

首次发布 (估计)

2005年9月15日

研究记录更新

最后更新发布 (估计)

2016年2月8日

上次提交的符合 QC 标准的更新

2016年1月10日

最后验证

2016年1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.

Docetaxel的临床试验

3
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