NCT00077337已完成2 期
Phase II Trial of Depsipeptide (NSC-630176) in Colorectal Cancer Patients Who Have Received Either One or Two Prior Chemotherapy Regimens for Metastatic or Locally Advanced, Unresectable Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 176
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with unresectable locally advanced or metastatic colorectal cancer.
详细描述
OBJECTIVES:
- Determine the confirmed response (complete and partial) in patients with previously treated unresectable locally advanced or metastatic colorectal cancer treated with FR901228 (depsipeptide).
- Determine the time to treatment failure and overall survival of patients treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
OUTLINE: This is a 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.
Patients are followed every 8 weeks until disease progression and then every 3 months until 1 year after study entry and then every 6 months until 3 years after study entry.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed colorectal cancer meeting 1 of the following criteria:
- •Locally advanced unresectable disease
- •Distant metastatic disease
- •Measurable disease
- •Previously treated with at least 1, but no more than 2, prior chemotherapy regimens for unresectable locally advanced or metastatic disease
- •May have included irinotecan or oxaliplatin
- •No more than 1 prior chemotherapy regimen (not oxaliplatin-based) for advanced or metastatic disease if previously treated with oxaliplatin-based adjuvant chemotherapy
- •No more than 1 prior chemotherapy regimen (not irinotecan-based) for advanced or metastatic disease if previously treated with irinotecan-based adjuvant chemotherapy
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ upper limit of normal (ULN)
- •SGOT and SGPT ≤ 2.5 times ULN
- •Creatinine ≤ ULN
- •Cardiovascular
- •No New York Heart Association class III or IV congestive heart failure
- •No myocardial infarction within the past year
- •No uncontrolled dysrhythmias
- •No poorly controlled angina
- •No prior serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- •No left ventricular hypertrophy
- •QTc < 500 msec
- •No other significant cardiac disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No prior allergic reaction attributed to compounds of similar chemical or biological composition to FR901228
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent anticancer immunotherapy
- •Chemotherapy
- •See Disease Characteristics
- •At least 28 days since prior chemotherapy and recovered
- •No prior FR901228 (depsipeptide)
- •No other concurrent anticancer chemotherapy
- •Endocrine therapy
- •No concurrent anticancer hormonal therapy
- •Radiotherapy
- •At least 28 days since prior radiotherapy and recovered
- •No concurrent anticancer radiotherapy
- •At least 28 days since prior surgery and recovered
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- 另有 5 项未显示
排除标准
- 未提供
研究者
研究点 (176)
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