NCT00087282已完成2 期
A Non-Randomized Phase II Study of Sequential Irinotecan (CPT-11) And Flavopiridol In Patients With Advanced Hepatoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan and flavopiridol, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with flavopiridol works in treating patients with advanced liver cancer.
详细描述
OBJECTIVES:
Primary
- Determine the time to progression in patients with advanced hepatocellular carcinoma treated with irinotecan and flavopiridol.
Secondary
- Determine the response rate and overall survival in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
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 hepatocellular carcinoma
- •Advanced disease
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Prior local therapy (e.g., surgery, hepatic arterial embolization, radiofrequency ablation, or cryoablation) allowed provided therapy was completed ≥ 8 weeks before study entry AND ≥ 1 of the following conditions are met:
- •Target lesion was not subjected to local therapy
- •25% increase in the size of target lesion within the field of prior local therapy
- •Lesions treated with external beam radiotherapy are not acceptable as target lesions
- •Child-Pugh class A or B status if liver cirrhosis is present
- •Score 7 or 8 only
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 75,000/mm^3
- •WBC ≥ 3,000/mm^3
- •See Disease Characteristics
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Bilirubin ≤ 1.5 mg/dL
- •Creatinine normal OR
- •Creatinine clearance ≥ 60 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No deep vein thrombosis within the past 6 months
- •Patients maintained on anticoagulation therapy for an event that occurred more than 6 months ago are eligible
- •No myocardial infarction within the past 6 months
- •No cardiac arrhythmia within the past 6 months
- •Rate-controlled atrial fibrillation allowed if stable for at least 6 months
- •No pulmonary embolus within the past 6 months
- •Patients maintained on anticoagulation therapy for an event that occurred more than 6 months ago are eligible
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study participation
- •No prior allergic reaction attributed to compounds of similar chemical or biological composition to flavopiridol or irinotecan
- •No clinically significant gastrointestinal bleeding requiring hospitalization within the past month
- •No active or ongoing infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or superficial bladder tumors [Ta, Tis, or T1]
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior systemic biologic therapy
- •Chemotherapy
- 另有 13 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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