Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma
2018年1月21日 更新者:University of Southern California
Phase II Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma
This study is for people with advanced gastric or gastroesophageal cancer.
This study is being done to find out how long it takes tumors to grow after receiving treatment with the drugs irinotecan (also known as CPT-11) and docetaxel (also known as Taxotere).
Irinotecan is a drug that has been approved by the Food and Drug Administration (FDA).
Irinotecan has been approved for treatment of cancer of the colon and rectum.
Docetaxel is another drug approved by the FDA.
Docetaxel is approved for treatment of breast, prostate and lung cancer.
However, the FDA has authorized the use of irinotecan and docetaxel in this study.
This study will evaluate the effects of these drugs on participant's tumors.
The side effects of the combination of irinotecan and docetaxel will also be evaluated.
This study will also measure the levels of certain substances in participant's tumors.
These substances, called genes (which are the cell's blueprint), affect how people's bodies react to the cancer drugs.
Genes will also be measured in participant's blood.
The researchers want to see if these substances can predict response to the study drugs.
研究概览
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
-
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California
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Los Angeles、California、美国、90033
- University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center
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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
18年 及以上 (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:
- Patients must have clinically documented unresectable or metastatic gastric cancer or gastroesophageal adenocarcinoma and histologic confirmation of the diagnosis with tumor.
- Patients must have received one prior chemotherapeutic regimen for metastatic or unresectable disease. Patients may not have received prior therapy with irinotecan or a taxane.
- Tissue from tumor must be available. This may be paraffin embedded tissue from previous biopsy/resection or if it is not available, a repeat biopsy must be performed.
- Patients must agree to have a 20 cc blood sample drawn in addition to routine labs with each cycle of chemotherapy.
- Patients must have measurable disease by clinical exam or radiologic studies, that is at least one lesion measurable in at least one dimension, measuring 10 mm or more on a spiral CT scan, or at least 20 mm by an exam or a non-spiral scan. If prior radiation therapy was administered, measurable disease must be outside the radiation field.
- Patients must have a Zubrod performance status of 0-2.
- Patients must have a predicted life expectancy of at least 12 weeks.
Patients must have:
- a pre-treatment granulocyte count (i.e., segmented neutrophils + bands) of >1,500/mm3,
- a hemoglobin level of greater than or equal to 9.0 gm/dl, and
- a platelet count of >100,000/mm3.
- Patients must have adequate renal function as documented by a calculated creatinine clearance > 60.
- Patients must have adequate hepatic function as documented by a serum bilirubin less than or equal to the institutional upper limit of normal, regardless of whether patients have liver involvement secondary to tumor.
- No major surgery within 1 month of starting study drug.
- Women of childbearing potential must have a negative pregnancy test.
- Peripheral neuropathy: must be < grade 1
Exclusion Criteria:
- Patients may not have a history of an allergy to irinotecan.
- Patients with any active or uncontrolled infection, including known HIV infection.
- Patients with psychiatric disorders that would interfere with consent or follow-up.
- Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy.
- Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on treatment and for at least 3 months thereafter.
- Presence of clinically apparent central nervous system metastases or carcinomatous meningitis.
- Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other anti-epileptic prophylaxis are ineligible.
- Patients with any other severe concurrent disease, which in the judgment of the investigator would make the patient inappropriate for entry into this study.
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
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:Arm 1 - Irinotecan and Docetaxel
Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days
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docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.
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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 |
---|---|---|
Objective Response (Complete, Partial, Stable and Progression)
大体时间:every 2 cycles
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Objective response was defined using standard RECIST criteria.
CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter or target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet criteria of CR, PR, and PD.
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every 2 cycles
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Progression Free Survival
大体时间:every 2 cycles
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Progression free survival is measured from the start of treatment until the time the participant is first recorded as having disease progression, or death due to any cause.
If a participant has not progressed or died, progression free survival is censored at the time of the last follow up.
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every 2 cycles
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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。
合作者
调查人员
- 首席研究员:Syma Iqbal, M.D.、University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center
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 (实际的)
2005年4月14日
初级完成 (实际的)
2014年10月20日
研究完成 (实际的)
2015年10月20日
研究注册日期
首次提交
2005年9月9日
首先提交符合 QC 标准的
2005年9月9日
首次发布 (估计)
2005年9月16日
研究记录更新
最后更新发布 (实际的)
2018年2月19日
上次提交的符合 QC 标准的更新
2018年1月21日
最后验证
2017年12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.