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Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer

2014年5月2日 更新者:National Cancer Institute (NCI)

A Phase II Trial Of Gemcitabine in Combination With 17-Allylaminogeldamycin (17-AAG) In Advanced Epithelial Ovarian And Primary Peritoneal Carcinoma

Phase II trial to study the effectiveness of gemcitabine hydrochloride and tanespimycin in treating patients who have recurrent advanced ovarian epithelial or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and tanespimycin, work in different ways to stop tumor cells from dividing so they stop growing or die.

研究概览

详细说明

OBJECTIVES:

I. Determine the response rate, time to progression, and survival of patients with recurrent advanced ovarian epithelial or primary peritoneal cavity cancer treated with gemcitabine hydrochloride and 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) (tanespimycin).

II. Determine the toxicity of this regimen in these patients. III. Correlate the effect of 17-AAG alone on chaperone and client proteins in tumor samples and peripheral blood mononuclear cells with response, time to progression, and survival of these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to gemcitabine hydrochloride therapy (gemcitabine hydrochloride-naive/no prior exposure to gemcitabine hydrochloride vs gemcitabine hydrochloride-resistant/prior exposure to gemcitabine hydrochloride as a single agent with disease progression while on treatment). Patients receive tanespimycin intravenously (IV) over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.

研究类型

介入性

注册 (实际的)

29

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

    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic

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

女性

描述

Inclusion Criteria:

  • Diagnosis of ovarian epithelial or primary peritoneal cavity cancer

    • Relapsed disease
    • Persistent disease
  • Platinum-resistant disease, defined as having evidence of disease that would be expected to be non-responsive to additional platinum-containing regimens or contraindication to platinum-based chemotherapy and 1 of the following:

    • Failure to obtain a complete response to initial platinum therapy
    • Recurrence < 6 months after completing a platinum-containing regimen for initial or recurrent disease
    • Any of the above situations and following treatment with additional chemotherapy regimens (e.g., non-platinum containing regimens)
    • Relative or absolute contraindication to platinum-based chemotherapy regimens (e.g., platinum allergy) as determine by the investigator
  • Measurable or evaluable disease

    • Patients with a rising CA 125 level, even in the absence of other indicators of disease, allowed provided CA 125 is ≥ 2 times upper limit of normal (ULN)
  • Patients with accessible disease must be willing to undergo tumor biopsies
  • No CNS metastases
  • Performance status - ECOG 0-2
  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Bilirubin normal
  • Alkaline phosphatase ≤ 2.5 times ULN
  • AST ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Ejection fraction > 40% by ECHO for patients with prior anthracycline therapy
  • No significant cardiac disease including any of the following:

    • New York Heart Association class III or IV heart disease
    • History of myocardial infraction within the past year
    • Uncontrolled dysrhythmias or requirement for antiarrhythmic drugs
    • Poorly controlled angina
  • No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
  • No history of QTc ≥ 500 msec
  • No active ischemic heart disease within the past 12 months
  • No congenital long QT syndrome
  • No left bundle branch block
  • No cardiac symptoms ≥ grade 2
  • No history of cardiac toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone, bleomycin, or carmustine)
  • Does not meet the medicare criteria for home oxygen
  • No pulse oximetry at rest and exercise < 88%
  • No symptomatic pulmonary disease requiring medication including any of the following:

    • Dyspnea on or off exertion
    • Paroxysmal nocturnal dyspnea
    • Oxygen requirement
    • Significant pulmonary disease (e.g., chronic obstructive/restrictive pulmonary disease)
  • No pulmonary symptoms ≥ grade 2
  • No history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone, bleomycin, or carmustine)
  • K+, Mg ++, and Ca ++ normal
  • No seizure disorder
  • No uncontrolled infection
  • No history of serious allergic reaction to eggs
  • More than 4 weeks since prior immunotherapy
  • More than 4 weeks since prior biologic therapy
  • No concurrent immunotherapy
  • No concurrent routine or prophylactic colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
  • Prior gemcitabine hydrochloride allowed provided 1 of the following criteria is met:

    • Patients have no prior exposure to gemcitabine hydrochloride
    • Patients who have prior exposure to gemcitabine hydrochloride as a single agent have experienced progressive disease while on treatment
  • No other concurrent chemotherapy
  • No prior radiotherapy to > 25% of bone marrow
  • No history of radiotherapy that potentially included the heart in the field (e.g., mantle)

    • Chest wall irradiation or other radiotherapy techniques that do not include the heart in the radiation field area allowed
  • More than 4 weeks since prior radiotherapy
  • More than 4 weeks since prior radiopharmaceuticals
  • No concurrent radiotherapy
  • No other concurrent investigational therapy
  • No concurrent medications that may prolong QTc

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:Treatment (chemotherapy)
Patients are stratified according to gemcitabine hydrochloride therapy (gemcitabine hydrochloride-naive/no prior exposure to gemcitabine hydrochloride vs gemcitabine hydrochloride-resistant/prior exposure to gemcitabine hydrochloride as a single agent with disease progression while on treatment). Patients receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
鉴于IV
其他名称:
  • 金扎
  • 吉西他滨
  • dFdC
  • 二氟脱氧胞苷盐酸盐
鉴于IV
其他名称:
  • 17-AAG

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
Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria.
大体时间:Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum).

Objective response will be measured using the modified RECIST criteria. A confirmed response requires an objective status of complete or partial response on 2 consecutive evaluations occurring 4 or more weeks apart.

Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.

Partial Response (PR): At least a 30% decrease in the sum of the target lesions from the baseline.

Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum).

次要结果测量

结果测量
措施说明
大体时间
Times to Progression
大体时间:Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.
Defined as the time from registration to the date of progression or last follow-up, whichever comes first. Estimated using the method of Kaplan-Meier
Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.
Overall Survival
大体时间:Every 3 months until disease progression and then every 6 months for up to 5 years.
Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier.
Every 3 months until disease progression and then every 6 months for up to 5 years.
Toxicity
大体时间:Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)
Defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 as an adverse event classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Participants were evaluated every 6 weeks on treatment (maximum 42 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。

调查人员

  • 首席研究员:Paul Haluska、Mayo Clinic

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

2007年10月1日

初级完成 (实际的)

2010年4月1日

研究完成 (实际的)

2012年3月1日

研究注册日期

首次提交

2004年10月6日

首先提交符合 QC 标准的

2004年10月7日

首次发布 (估计)

2004年10月8日

研究记录更新

最后更新发布 (估计)

2014年5月20日

上次提交的符合 QC 标准的更新

2014年5月2日

最后验证

2011年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • NCI-2009-00052 (注册表标识符:CTRP (Clinical Trial Reporting Program))
  • P30CA015083 (美国 NIH 拨款/合同)
  • N01CM62205 (美国 NIH 拨款/合同)
  • 6307 (其他标识符:CTEP)
  • CDR0000388036
  • NCI-6307
  • MAYO-MC0362
  • MC0362 (其他标识符:Mayo Clinic)

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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