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Squalamine Lactate Plus Carboplatin in Treating Patients With Recurrent or Refractory Stage III or Stage IV Ovarian Cancer

2013年12月17日 更新者:Jonsson Comprehensive Cancer Center

A Phase IIA Trial of Continuous Five Day Infusions of MSI-1256F (Squalamine Lactate) Plus Carboplatin for Therapy of Refractory and Resistant Stage III and IV Ovarian Cancer

RATIONALE: Squalamine lactate may stop or slow the growth of ovarian cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining squalamine lactate with carboplatin may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining squalamine lactate and carboplatin in treating patients who have recurrent or refractory stage III or stage IV ovarian cancer.

研究概览

地位

未知

条件

详细说明

OBJECTIVES: I. Determine the response rate and time to progression in patients with recurrent or refractory stage III or IV ovarian cancer treated with squalamine lactate and carboplatin. II. Determine the safety profile of this regimen in these patients.

OUTLINE: Patients receive carboplatin IV over 15-30 minutes on day 1 and squalamine lactate IV continuously on days 1-5. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at approximately 1 month.

PROJECTED ACCRUAL: Approximately 45 patients will be accrued for this study.

研究类型

介入性

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

    • California
      • Los Angeles、California、美国、90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA

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

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian cancer Refractory disease Progression on prior primary paclitaxel and carboplatin OR Resistant disease Recurrence within 12 months of initial response after completion of prior paclitaxel and carboplatin Recurrence within 12 months of initial response to a prior secondary or tertiary regimen allowed Bidimensionally measurable or evaluable disease OR Elevated CA125 level CA125 at least 100 U/mL (risen from prior lower levels) OR CA125 greater than 50 U/mL but less than 100 U/mL (at least doubled from prior lower levels) No known brain metastases unless clinically stable after treatment with prior surgery and/or radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 OR SWOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 OR Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST less than 5 times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No significant cardiac disease No uncontrolled high blood pressure No unstable angina No congestive heart failure No myocardial infarction within the past year No serious cardiac arrhythmia requiring medication Other: No clinically significant neuropathy No other active malignancy No uncontrolled serious active infection No uncontrolled diabetes mellitus No other condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 30 days after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biological response modifiers No prior anti-angiogenesis agents No prior squalamine lactate No concurrent growth factors, except for epoetin alfa Chemotherapy: See Disease Characteristics Received 1-3 prior chemotherapy regimens for ovarian cancer At least 5 years since prior chemotherapy for other malignancy Endocrine therapy: Concurrent hormonal therapy allowed if therapy initiated at least 6 months prior to study Radiotherapy: See Disease Characteristics Recovered from prior radiotherapy At least 5 years since prior radiotherapy for other malignancy No prior radiotherapy to only area of measurable or evaluable disease unless that site had subsequent disease progression Concurrent localized radiotherapy for pain or symptom relief allowed if other methods are ineffective and measurable and/or evaluable disease remains outside the radiotherapy portals Surgery: See Disease Characteristics Other: At least 30 days since prior investigational therapy No prior enrollment in this study No other concurrent antitumor treatment No other concurrent investigational therapy

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

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

  • 学习椅:Linnea Chap, MD、Jonsson 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

2001年5月1日

研究注册日期

首次提交

2001年7月11日

首先提交符合 QC 标准的

2004年2月3日

首次发布 (估计)

2004年2月4日

研究记录更新

最后更新发布 (估计)

2013年12月18日

上次提交的符合 QC 标准的更新

2013年12月17日

最后验证

2002年5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.

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