FR901228 in Treating Patients With Refractory Stomach Cancer or Gastroesophageal Junction Cancer
A Phase 2 Study of Single Agent Depsipeptide (FK228) in Gastric and Esophageal Cancers
研究概览
详细说明
PRIMARY OBJECTIVES:
I. Determine the radiographic response rate (complete response and partial response) in patients with refractory adenocarcinoma of the stomach or gastroesophageal junction treated with FR901228 (depsipeptide).
SECONDARY OBJECTIVES:
I. Determine the median time to progression and progression-free survival of patients treated with this drug.
II. Determine the grade 3 and 4 toxic effects of this drug in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 13-20 patients will be accrued for this study within 6.5-10 months.
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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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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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
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Refractory* to at least 1, but no more than 3, of the following first-line agents:
- Fluoropyrimidine (e.g., capecitabine or fluorouracil)
- Taxane (e.g., paclitaxel or docetaxel)
- Platinum (e.g., carboplatin, cisplatin, or oxaliplatin)
No known active brain metastases
- Treated brain metastases allowed provided metastases are stable off steroids for ≥ 30 days
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- At least 3 months
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- Creatinine clearance ≥ 50 mL/min
- No congestive heart failure
- No New York Heart Association class III or IV heart disease
- No myocardial infarction within the past 6 months
- No ventricular arrhythmias requiring medication
- No angioplasty or vascular stenting within the past 3 months
- No unstable angina
- No left ventricular hypertrophy by EKG
- No known history of serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- QTc < 500 msec
- LVEF > 40% by MUGA or echocardiogram
- No other significant cardiac disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Potassium ≥ 4.0 mmol/L (stable level with no change in supplementation within the past 2 weeks)
- Magnesium ≥ 2.0 mg/dL (stable level with no change in supplementation within the past 2 weeks)
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drug
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- Prior biological agents allowed
- No concurrent prophylactic filgrastim (G-CSF)
- No concurrent biologic therapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No other concurrent chemotherapy
- More than 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
- Prior targeted agents allowed
- No other prior or concurrent cytotoxic agents
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- No concurrent medications causing QTc prolongation
- No concurrent potassium supplementation > 40 mg/day or magnesium supplementation > 1 g/week
- No concurrent hydrochlorothiazide
- 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 |
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实验性的:治疗(罗米地辛)
患者在第 1、8 和 15 天接受 FR901228(缩酚肽)静脉注射超过 4 小时。
在没有疾病进展或不可接受的毒性的情况下,课程每 28 天重复一次。
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相关研究
鉴于IV
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Radiographic response rate (complete response & partial response)
大体时间:Not Provided
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Not Provided
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Progression-free survival (PFS) according to RECIST
大体时间:Up to more than 6 months
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The median time to progression and median PFS for all eligible patients, along with their CIs, will be reported.
The Kaplan-Meier analysis approach may be used to summarize these time-to-event endpoints.
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Up to more than 6 months
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Frequency of treatment related grade 1-4 toxicities and cardiac toxicities as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
大体时间:Up to 12 months
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Up to 12 months
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Correlation of changes in gene expression profile in dermal granulation tissue pre- and post-treatment with gene expression profile
大体时间:Not Provided
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Not Provided
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Correlation of wound vascular scores pre- and post-treatment with gene/protein changes
大体时间:Not Provided
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Not Provided
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Toxicity
大体时间:Not Provided
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Not Provided
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Changes in gene expression profile
大体时间:At pre- and post-treatment
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At pre- and post-treatment
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Changes in levels of p21 and thymidine kinase expression, and tubulin acetylation using Western blotting
大体时间:From baseline to 3 weeks
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From baseline to 3 weeks
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Changes in gene expression profile in dermal granulation tissue
大体时间:From baseline to up to 3 weeks
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From baseline to up to 3 weeks
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Change in plasma and urine TGFB levels
大体时间:At pre-and post-treatment
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At pre-and post-treatment
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合作者和调查者
调查人员
- 首席研究员:Herbert Hurwitz、Duke University
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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