Rebeccamycin Analog in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
A Phase II Study of Rebeccamycin Analogue NSC 655649 in Patients With Metastatic Colorectal Cancer (IMT Codes 23988, 23989, 23993)
研究概览
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
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Georgia
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Atlanta、Georgia、美国、30342
- Atlanta Cancer Care
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New York
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Bronx、New York、美国、10461
- Albert Einstein Comprehensive Cancer Center
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Valhalla、New York、美国、10595
- New York Medical College
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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
调查人员
- 学习椅:Sridhar Mani, MD、Albert Einstein College of Medicine
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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