NCT00003981已完成1 期
Phase I Study to Determine the Safety of E7070 in Patients With a Solid Tumor as a Single IV Infusion Weekly X 4, Repeated Every 6 Weeks
European Organisation for Research and Treatment of Cancer - EORTC52 个研究点 分布在 9 个国家目标入组 30 人开始时间: 1998年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 52
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 I trial to study the effectiveness of E7070 in treating patients who have solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of E7070 when administered to adult patients with solid tumors.
- Determine the qualitative and quantitative toxic effects of this drug and study the predictability, duration, intensity, onset, reversibility and dose relationship of the toxic effects in this patient population.
- Propose a safe dose for phase II study.
- Assess the pharmacokinetics of this drug at different dose levels in this patient population.
- Determine any possible antitumor activity of this drug in this patient population.
OUTLINE: This is a dose escalation study.
Patients receive E7070 IV over 1 hour on days 1, 8, 15, and 22. Treatment continues every 6 weeks for at least 2 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of E7070 is escalated until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 solid tumor that is not amenable to standard therapy
- •No brain involvement or leptomeningeal disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9 g/dL
- •Bilirubin less than 1.5 mg/dL
- •Liver function tests no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)
- •Creatinine no greater than 1.4 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No active bacterial infections (e.g., abscess or fistulae)
- •No other nonmalignant disease that precludes protocol therapy
- •No history of alcoholism, drug addiction, or psychotic disorders that preclude participation
- •No glaucoma
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •No other concurrent antitumor drugs
- •Endocrine therapy:
- •At least 4 weeks since prior anticancer hormonal therapy
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy)
- •No concurrent radiotherapy (except localized palliative radiotherapy)
- •Not specified
- •No concurrent sulfonylurea agent for diabetes or antiarrhythmic agents
- •No other concurrent investigational drugs
排除标准
- 未提供
研究者
研究点 (52)
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