NCT00054262已完成2 期
A Phase II Study Of Intravenous T900607-Sodium In Subjects With Chemotherapy-Naive Unresectable Hepatocellular Carcinoma
University Hospitals Seidman Cancer Center2 个研究点 分布在 1 个国家开始时间: 2002年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of T900607 in treating patients who have unresectable liver cancer.
详细描述
OBJECTIVES:
- Determine the complete and partial response rates of patients with chemotherapy-naïve unresectable hepatocellular carcinoma treated with T900607.
- Determine the efficacy of this drug, in terms of duration of response and time to disease progression, in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the safety profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive T900607 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
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 unresectable hepatocellular carcinoma (HCC)
- •Bidimensionally measurable disease defined as at least 1 lesion that is 1 cm or more in 2 dimensions by CT scan
- •Class A or B Child-Pugh liver classification
- •No prior CNS metastases or carcinomatous meningitis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3*
- •Platelet count at least 100,000/mm^3*
- •Hemoglobin at least 8.5 g/dL* NOTE: *More than 7 days since prior blood transfusions or growth factors
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Albumin greater than 2.5 g/dL
- •AST and ALT no greater than 3 times ULN
- •INR no greater than 1.5 (unless receiving anticoagulants)
- •Creatinine no greater than 2 times ULN
- •Cardiovascular
- •LVEF at least 50%
- •No New York Heart Association class III or IV cardiac disease
- •No acute anginal symptoms
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study
- •No severe concurrent disease, infection, or co-morbidity that would preclude study entry
- •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
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior immunotherapy for HCC
- •No concurrent therapeutic biological response modifier
- •Chemotherapy
- •No prior chemotherapy for HCC
- •No prior chemoembolization for HCC
- •No other concurrent cytotoxic chemotherapy
- •Endocrine therapy
- •At least 6 weeks since prior hormonal therapy (an indicator lesion must exist outside the area of therapy
- •No concurrent hormonal anticancer therapy
- •Radiotherapy
- •No prior radiotherapy for HCC
- •At least 6 weeks since prior radiofrequency ablation, selective internal radiation, or embolization (an indicator lesion must exist outside the area of therapy)
- •No concurrent radiotherapy (including palliative therapy)
- •At least 6 weeks since prior surgical resection (an indicator lesion must exist outside the area of therapy)
- •Recurrence at the margin of the surgical resection is allowed
- •At least 6 weeks since prior cryosurgery
- •More than 4 weeks since other prior major surgery
- •More than 4 weeks since prior investigational therapy
- •At least 6 weeks since prior intratumoral ethanol injection (an indicator lesion must exist outside the area of therapy)
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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