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PEG-Interferon Alfa-2b in Treating Patients With Platinum-Resistant Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer

2012年8月1日 更新者:M.D. Anderson Cancer Center

A Phase I/II Study to Evaluate the Optimum Dose of Pegylated-Interferon (PEG INTRON) in Patients With Platinum Resistant Ovarian, Peritoneal or Fallopian Tube Cancer

RATIONALE: PEG-interferon alfa-2b may interfere with the growth of cancer cells.

PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of PEG-interferon alfa-2b and to see how well it works in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.

研究概览

详细说明

OBJECTIVES:

  • Determine the optimum biologic dose of PEG-interferon alfa-2b in patients with platinum-resistant ovarian epithelial, peritoneal, or fallopian tube cancer.
  • Determine the safety and tolerability of this drug in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 different treatment arms.

  • Arm I: Patients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22.
  • Arm II: Patients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22.
  • Arm III: Patients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22.

In all arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for at least 28 days after study treatment.

PROJECTED ACCRUAL: A maximum of 75 patients will be accrued for this study within 19 months.

研究类型

介入性

注册 (实际的)

30

阶段

  • 阶段2
  • 阶段1

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

    • Texas
      • Houston、Texas、美国、77030
        • M D Anderson Cancer 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

  • 孩子
  • 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:

  1. Women with platinum-resistant epithelial ovarian, fallopian tube or peritoneal cancer whose tumor test positive for IL-8 (>31.0 pg/ml), bFGF >7.0 pg/ml), or VEGF (>700 pg/ml). Resistance is defined as:

    1. Progression of disease during platinum chemotherapy, or
    2. Progression of disease within 6 months of completing platinum chemotherapy
    3. Failure to achieve a complete response, with persistent macroscopic disease, after 6 cycles of chemotherapy, if the last two cycles had no measurable change in disease status
  2. Patients with a known hypersensitivity to platinum compounds who have failed a desensitization regimen, or who are not good candidates for desensitization are eligible.
  3. Patients are limited to 4 prior chemotherapy regimens (all platinum and taxane regimens to be counted as one).
  4. Patients must have measurable disease.
  5. Women of any racial and ethnic group.
  6. Zubrod performance status < 2.
  7. Expected survival of > 12 weeks.
  8. Patients must have adequate hepatic, renal, and bone marrow function, defined as serum creatinine < 2 mg/dl (estimated creatinine clearance 50 ml/min); total bilirubin < 2.0 X the upper limit of normal (ULN); alanine aminotransferase (ALT) < 2X ULN; fasting triglycerides < 800 mg/dL; white blood count (WBC) > 3,000/mm3 ; absolute neutrophil count (ANC) > 1,500/mm3; platelets > 100,000/mm3, hemoglobin > 9 g/dl.
  9. At least three weeks must have elapsed from completion of chemotherapy.
  10. Patient agrees not to use complementary alternative medications (e.g., shark cartilage).
  11. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the hospital. The only approved consent is appended to this protocol.

Exclusion Criteria:

  1. Patients with borderline, low grade or low malignant potential tumors are not eligible.
  2. Patients who are pregnant or lactating.
  3. Concurrent chemotherapy, radiation therapy or surgery.
  4. Concurrent, uncontrolled, medical or psychiatric disorders.
  5. Patients with a known hypersensitivity to interferon.
  6. Patients with severe cardiovascular disease (i.e. arrhythmias requiring chronic treatment or congestive heart failure) (NYHA classification III or IV).
  7. Patients who have had interferon within the last 6 months.
  8. Patients with overt psychosis or mental disability or otherwise incompetent to give informed consent.
  9. Patients with a known autoimmune disorder.

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: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
实验性的:PEG-interferon alfa-2b
Patients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22.
Starting dose 1.0 mg/kg/week given subcutaneously
其他名称:
  • PEG-内含子

Biological/Vaccine: PEG-interferon alfa-2b

Dose 1.5 mg/kg/week given subcutaneously

EG-Intron

其他名称:
  • PEG-内含子
实验性的:Arm II
Patients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22.

Biological/Vaccine: PEG-interferon alfa-2b

Dose 1.25 mg/kg/week given subcutaneously

其他名称:
  • PEG-内含子
实验性的:Arm III
Patients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22.
Starting dose 1.0 mg/kg/week given subcutaneously
其他名称:
  • PEG-内含子

Biological/Vaccine: PEG-interferon alfa-2b

Dose 1.5 mg/kg/week given subcutaneously

EG-Intron

其他名称:
  • PEG-内含子

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
Optimal Biologic Dose at 8 weeks
大体时间:8 weeks
Optimum biologic dose of PEG Intron in patients with platinum-resistant ovarian, fallopian tube or peritoneal cancer whose tumors test positive for IL-8, BFGF, or VEGF.
8 weeks
Tumor Response
大体时间:Every 2 -3 cycles (8 - 12 weeks)
Each patient tumor response scored as either complete/partial response (CR/PR), stable disease (SD), or failure (F) at 8 weeks after initial treatment.
Every 2 -3 cycles (8 - 12 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

  • 学习椅:Judith K. Wolf, MD、M.D. Anderson Cancer Center
  • 学习椅:Pedro T. Ramirez, MD、M.D. Anderson Cancer Center
  • 学习椅:Diane C. Bodurka, MD、M.D. Anderson Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2002年7月1日

初级完成 (实际的)

2005年11月1日

研究完成 (实际的)

2007年4月1日

研究注册日期

首次提交

2004年6月10日

首先提交符合 QC 标准的

2004年6月10日

首次发布 (估计)

2004年6月11日

研究记录更新

最后更新发布 (估计)

2012年8月2日

上次提交的符合 QC 标准的更新

2012年8月1日

最后验证

2012年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • ID02-115
  • P30CA016672 (美国 NIH 拨款/合同)
  • P50CA083639 (美国 NIH 拨款/合同)
  • MDA-ID-02115 (其他标识符:UT MD Anderson Cancer Center)
  • CDR0000368964 (注册表标识符:NCI PDQ)

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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