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Rebeccamycin Analog in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer

2013年2月8日 更新者:National Cancer Institute (NCI)

A Phase II Study of Rebeccamycin Analogue NSC 655649 in Patients With Metastatic Colorectal Cancer (IMT Codes 23988, 23989, 23993)

Phase II trial to study the effectiveness of rebeccamycin analog in treating patients who have metastatic or locally recurrent colorectal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

研究概览

地位

完全的

条件

详细说明

OBJECTIVES:

I. Determine the objective response rate of patients with metastatic or locally recurrent colorectal cancer treated with rebeccamycin analogue.

II. Determine the toxicity of this regimen in this patient population. III. Determine the effect of this regimen on progression-free and overall survival in these patients.

OUTLINE: This is a multicenter study.

Patients receive rebeccamycin analogue IV once on day 1. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

研究类型

介入性

注册 (实际的)

37

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

    • Georgia
      • Atlanta、Georgia、美国、30342
        • Atlanta Cancer Care
    • New York
      • Bronx、New York、美国、10461
        • Albert Einstein Comprehensive Cancer Center
      • Valhalla、New York、美国、10595
        • New York Medical College

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed metastatic or locally recurrent adenocarcinoma of the colon or rectum
  • No curable stage of disease
  • At least 1 unidimensionally measurable lesion
  • At 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No tumor lesions in previously irradiated area except clearly measurable lesion documented histologically to be consistent with recurrent tumor in previously irradiated bed within pelvis
  • The following are considered nonmeasurable disease:

    • Bone lesions Leptomeningeal disease
    • Ascites
    • Pleural/pericardial effusion
    • Inflammatory breast disease
    • Lymphangitis cutis/pulmonis
    • Abdominal masses not confirmed and followed by imaging techniques
    • Cystic lesions
    • No known brain metastases

PATIENT CHARACTERISTICS:

  • Age: 18 and over
  • Performance status: ECOG 0-2 OR Karnofsky 60-100%
  • Life expectancy: More than 12 weeks
  • WBC at least 3,000/mm3
  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance at least 60 mL/min
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study
  • Eligible for placement of a central venous catheter
  • No prior allergic reactions attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue
  • No other uncontrolled concurrent illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • No concurrent prophylactic growth factors (e.g., epoetin alfa) except for clinically defined indication (e.g., filgrastim (G-CSF) for febrile neutropenia)
  • At least 4 weeks since prior chemotherapy (e.g., fluorouracil, oral fluoropyrimidines, irinotecan, or oxaliplatin) (6 weeks for nitrosoureas or mitomycin)
  • No other concurrent chemotherapy
  • No concurrent hormones except for clinically defined indication
  • At least 4 weeks since prior radiotherapy (including to bony sites, whole pelvis, lung, liver, or spinal cord/brain) and recovered
  • No prior total dose of radiotherapy more than 7,000 cGy
  • No prior radiotherapy to 40% or more of total bone marrow
  • No prior radiotherapy to only site of measurable disease
  • No concurrent radiotherapy
  • Recovered from prior therapy 1 prior adjuvant treatment allowed 1 prior treatment for advanced disease allowed
  • At least 4 weeks since prior investigational agents
  • No other concurrent investigational antineoplastic drugs
  • No other concurrent investigational agents
  • No concurrent commercial agents for colorectal cancer
  • No concurrent combination antiretroviral therapy for HIV-positive patients

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:Arm I
Patients receive rebeccamycin analogue IV once on day 1. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

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:Sridhar Mani, MD、Albert Einstein College of Medicine

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

2000年2月1日

初级完成 (实际的)

2002年6月1日

研究注册日期

首次提交

2000年4月6日

首先提交符合 QC 标准的

2004年3月15日

首次发布 (估计)

2004年3月16日

研究记录更新

最后更新发布 (估计)

2013年2月11日

上次提交的符合 QC 标准的更新

2013年2月8日

最后验证

2002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.

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